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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03816163
Registration number
NCT03816163
Ethics application status
Date submitted
23/01/2019
Date registered
25/01/2019
Date last updated
28/05/2024
Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of IMAB362 in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma
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Scientific title
A Phase 2, Open-Label, Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (IMAB362) in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma
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Secondary ID [1]
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2018-002551-15
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Secondary ID [2]
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8951-CL-5201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer
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Metastatic Pancreatic Cancer
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Metastatic Pancreatic Adenocarcinoma
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Condition category
Condition code
Cancer
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Pancreatic
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - zolbetuximab
Treatment: Drugs - nab-paclitaxel
Treatment: Drugs - gemcitabine
Experimental: zolbetuximab +nab-paclitaxel + gemcitabine - Participants will be treated with zolbetuximab in combination with nab-paclitaxel and gemcitabine for the phase 1 portion of the study to establish the recommended dose of zolbetuximab for the phase 2 portion. In the phase 2 portion, the participants will be treated with zolbetuximab at dose determined by the phase 1 portion of the study in combination with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.
Active Comparator: nab-paclitaxel + gemcitabine - Participants will be treated with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.
Treatment: Drugs: zolbetuximab
Administered as an intravenous infusion.
Treatment: Drugs: nab-paclitaxel
Administered as an intravenous infusion
Treatment: Drugs: gemcitabine
Administered as an intravenous infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Dose Limiting Toxicities (DLT) - (safety lead in)
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Assessment method [1]
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Incidence of dose limiting toxicities.
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Timepoint [1]
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Up to 28 days
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is defined as the time from the date of randomization until the date of death from any cause.
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Timepoint [2]
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Up to 65 months
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Primary outcome [3]
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Safety assessed by Adverse Events (AEs)
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Assessment method [3]
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An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
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Timepoint [3]
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Up to 65 months
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Primary outcome [4]
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Safety assessed by incidence of serious adverse events (SAE)
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Assessment method [4]
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Adverse Event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.
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Timepoint [4]
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Up to 65 months
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Primary outcome [5]
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Safety assessed by incidence of treatment emergent adverse events (TEAE)
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Assessment method [5]
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Treatment Emergent Adverse Event (TEAE) is defined as any AE which starts, or worsens, after the first dose of study drug through 30 days after the last dose of study drug.
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Timepoint [5]
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Up to 65 months
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Primary outcome [6]
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Number of participants with laboratory value abnormalities and/or adverse events (AEs)
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Assessment method [6]
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Number of participants with potentially clinically significant laboratory values.
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Timepoint [6]
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Up to 65 months
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Primary outcome [7]
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Number of participants with vital sign abnormalities and /or adverse events (AEs)
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Assessment method [7]
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Number of participants with potentially clinically significant vital sign values.
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Timepoint [7]
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Up to 65 months
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Primary outcome [8]
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Number of participants with electrocardiograms (ECG) abnormalities and or adverse events
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Assessment method [8]
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12-lead ECGs will be recorded. Prior to the ECG, participants should rest in supine position for 10 minutes. ECGs will be read and assessed locally.
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Timepoint [8]
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Up to 65 months
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Primary outcome [9]
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Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events
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Assessment method [9]
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Number of participants with potentially clinically significant ECOG performance status values. ECOG grades 0-5, where 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair and 5 = Dead.
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Timepoint [9]
0
0
Up to 65 months
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Secondary outcome [1]
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Progression Free Survival (PFS)
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Assessment method [1]
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PFS is defined as the time from the date of randomization until the date of radiological progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by investigator evaluation or death from any cause, whichever is earliest.
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Timepoint [1]
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Up to 65 months
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Secondary outcome [2]
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Objective Response Rate (ORR)
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Assessment method [2]
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ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1.
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Timepoint [2]
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Up to 65 months
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Secondary outcome [3]
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Number of anti-drug antibody (ADA) Positive Participants
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Assessment method [3]
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Immunogenicity will be measured by the number of participants that are ADA positive.
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Timepoint [3]
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Up to 65 months
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Secondary outcome [4]
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Disease Control Rate (DCR)
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Assessment method [4]
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DCR is defined as the proportion of participants who have best overall response of stable disease, complete response (CR) or partial response (PR) as assessed by investigator evaluation per RECIST 1.1
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Timepoint [4]
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Up to 65 months
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Secondary outcome [5]
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Duration Of Response (DOR)
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Assessment method [5]
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DOR is defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by investigator evaluation per RECIST 1.1 or date of death from any cause, whichever is earliest.
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Timepoint [5]
0
0
Up to 65 months
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Secondary outcome [6]
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Change in CA (Cancer Antigen) 19-9
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Assessment method [6]
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Change from baseline in serum CA19-9 will be assessed.
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Timepoint [6]
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Baseline up to 65 months
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Secondary outcome [7]
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PK of zolbetuximab: Concentration Immediately Prior to Dosing (Ctrough)
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Assessment method [7]
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Ctrough will be derived from the PK serum samples collected.
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Timepoint [7]
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Up to 65 months
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Secondary outcome [8]
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PK of Nab-P: Area Under the Concentration-time Curve from the Time of Dosing Extrapolated to Time Infinity (AUCinf)
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Assessment method [8]
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AUCinf will be derived from the PK plasma samples collected.
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Timepoint [8]
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Up to 30 days
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Secondary outcome [9]
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PK of Nab-P: Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)
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Assessment method [9]
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AUClast will be derived from the PK plasma samples collected.
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Timepoint [9]
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Up to 30 days
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Secondary outcome [10]
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PK of Nab-P: Maximum Concentration (Cmax)
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Assessment method [10]
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Cmax will be derived from the PK plasma samples collected.
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Timepoint [10]
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Up to 30 days
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Secondary outcome [11]
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PK of Nab-P: Time of Maximum Concentration (Tmax)
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Assessment method [11]
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Tmax will be derived from the PK plasma samples collected.
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Timepoint [11]
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Up to 30 days
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Secondary outcome [12]
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PK of Nab-P: Terminal Elimination Half-life (T1/2)
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Assessment method [12]
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T1/2 will be derived from the PK plasma samples collected.
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Timepoint [12]
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Up to 30 days
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Secondary outcome [13]
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PK of Nab-P: Clearance (CL)
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Assessment method [13]
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CL will be derived from the PK plasma samples collected.
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Timepoint [13]
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Up to 30 days
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Secondary outcome [14]
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PK of Nab-P: Volume of Distribution During the Terminal Phase (Vz)
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Assessment method [14]
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Vz will be derived from the PK plasma samples collected.
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Timepoint [14]
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Up to 30 days
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Secondary outcome [15]
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PK of gemcitabine: Area Under the Concentration-time Curve from the Time of Dosing Extrapolated to Time Infinity (AUCinf)
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Assessment method [15]
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AUCinf will be derived from the PK plasma samples collected.
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Timepoint [15]
0
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Up to 30 days
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Secondary outcome [16]
0
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PK of gemcitabine: Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)
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Assessment method [16]
0
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AUClast will be derived from the PK plasma samples collected.
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Timepoint [16]
0
0
Up to 30 days
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Secondary outcome [17]
0
0
PK of gemcitabine: Maximum Concentration (Cmax)
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Assessment method [17]
0
0
Cmax will be derived from the PK plasma samples collected.
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Timepoint [17]
0
0
Up to 30 days
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Secondary outcome [18]
0
0
PK of gemcitabine: Time of Maximum Concentration (Tmax)
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Assessment method [18]
0
0
Tmax will be derived from the PK plasma samples collected.
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Timepoint [18]
0
0
Up to 30 days
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Secondary outcome [19]
0
0
PK of gemcitabine: Terminal Elimination Half-life (T1/2)
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Assessment method [19]
0
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T1/2 will be derived from the PK plasma samples collected.
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Timepoint [19]
0
0
Up to 30 days
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Secondary outcome [20]
0
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PK of gemcitabine: Clearance (CL)
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Assessment method [20]
0
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CL will be derived from the PK plasma samples collected.
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Timepoint [20]
0
0
Up to 30 days
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Secondary outcome [21]
0
0
PK of gemcitabine: Volume of Distribution During the Terminal Phase (Vz)
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Assessment method [21]
0
0
Vz will be derived from the PK plasma samples collected.
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Timepoint [21]
0
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Up to 30 days
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Secondary outcome [22]
0
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Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC-QLQ-C30)
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Assessment method [22]
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The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For functional scales, higher scores indicate better functioning, while for symptom scales/items, higher scores indicate worse symptoms.
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Timepoint [22]
0
0
Up to 65 months
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Secondary outcome [23]
0
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Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreatic Cancer Module (EORTC-QLQ-PAN-26)
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Assessment method [23]
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EORTC-QLQ-PAN26 is a 26-item questionnaire that evaluates pancreatic cancer-specific symptoms such as pain, dietary changes, jaundice, altered bowel habits, and emotional problems. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For symptom scales/items, higher scores indicate worse symptoms.
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Timepoint [23]
0
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Up to 65 months
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Secondary outcome [24]
0
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Health Related Quality of Life (HRQoL) measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L)
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Assessment method [24]
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The EQ-5D-5L is a standardized instrument for use as a measure of health outcome consisting of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale for health status.
Each domain comprises 5 severity levels (no problems, slight problems, moderate problems, severe problems, extreme problems). The general visual analog scale records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale. Responses to the 5 items will also be converted to a weighted health state index (utility score) based on values derived from general population samples.
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Timepoint [24]
0
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Up to 65 months
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Secondary outcome [25]
0
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Health Related Quality of Life (HRQoL) measured by the Patient Global Impression of Change (PGIC) scale
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Assessment method [25]
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The PGIC is a single-item questionnaire that asks participants to provide the overall self-assessment of change in their disease on a 7-point scale ranging from "very much worse" to "very much better" as compared to the participant starting the study treatment. Only PGIC questions assessing pain and overall status will be collected.
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Timepoint [25]
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Up to 65 months
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Secondary outcome [26]
0
0
Health Related Quality of Life (HRQoL) measured by the Patient Global Impression of Severity (PGIS) Scale
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Assessment method [26]
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The PGIS is a single-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week, with 1 as "None" and 4 as "Severe". Only PGIS questions assessing pain and overall status will be collected.
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Timepoint [26]
0
0
Up to 65 months
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Secondary outcome [27]
0
0
Time to Improvement of pancreatic pain as measured by Quality-of-Life Questionnaire - Core Questionnaire (QLQ-C30)
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Assessment method [27]
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The QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For functional scales, higher scores indicate better functioning, while for symptom scales/items, higher scores indicate worse symptoms.
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Timepoint [27]
0
0
Up to 65 months
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Secondary outcome [28]
0
0
Time to worsening of global health status (GHS)/quality of life (QoL) as measured by QLQ-C30
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Assessment method [28]
0
0
The QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For functional scales, higher scores indicate better functioning, while for symptom scales/items, higher scores indicate worse symptoms.
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Timepoint [28]
0
0
Up to 65 months
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Secondary outcome [29]
0
0
Time to Improvement of pancreatic pain as measured by Quality of Life Questionnaire - Pancreatic Cancer Module 26 (QLQ-PAN26)
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Assessment method [29]
0
0
EORTC-QLQ-PAN26 is a 26-item questionnaire that evaluates pancreatic cancer-specific symptoms such as pain, dietary changes, jaundice, altered bowel habits, and emotional problems. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For symptom scales/items, higher scores indicate worse symptoms.
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Timepoint [29]
0
0
Up to 65 months
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Secondary outcome [30]
0
0
Time to worsening of GHS/QoL as measured by QLQ-PAN26
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Assessment method [30]
0
0
EORTC-QLQ-PAN26 is a 26-item questionnaire that evaluates pancreatic cancer-specific symptoms such as pain, dietary changes, jaundice, altered bowel habits, and emotional problems. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For symptom scales/items, higher scores indicate worse symptoms.
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Timepoint [30]
0
0
Up to 65 months
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Secondary outcome [31]
0
0
Time to Improvement of pancreatic pain as measured by PGIS
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Assessment method [31]
0
0
The PGIS is a single-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week, with 1 as "None" and 4 as "Severe". Only PGIS questions assessing pain and overall status will be collected.
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Timepoint [31]
0
0
Up to 65 months
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Secondary outcome [32]
0
0
Time to worsening of GHS/QoL as measured by PGIS
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Assessment method [32]
0
0
The PGIS is a single-item questionnaire that asks participants to provide the overall self-assessment of their disease severity on a 4-point scale for the past week, with 1 as "None" and 4 as "Severe". Only PGIS questions assessing pain and overall status will be collected.
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Timepoint [32]
0
0
Up to 65 months
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Eligibility
Key inclusion criteria
- A female subject is eligible to participate if she is not pregnant or lactating and at
least 1 of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- WOCBP who agrees to follow the contraceptive guidance throughout the treatment
period and for at least 6 months after the final study drug administration.
- Female subject must agree not to breastfeed starting at screening and throughout the
study period, and for 6 months after the final study drug administration.
- Female subject must not donate ova starting at screening and throughout the study
period, and for 6 months after the final study drug administration.
- A male subject with female partner(s) of child-bearing potential must agree to use
contraception during the treatment period and for at least 6 months after the final
study drug administration.
- A male subject must not donate sperm during the treatment period and for at least 6
months after the final study drug administration.
- Male subject with a pregnant or breastfeeding partner(s) must agree to remain
abstinent or use a condom for the duration of the pregnancy or time partner is
breastfeeding throughout the study period and for 6 months after the final study drug
administration.
- Subject agrees not to participate in other interventional studies while receiving
study drug in present study.
- Subject has histologically or cytologically confirmed adenocarcinoma of pancreas.
- Subjects must have metastatic pancreatic adenocarcinoma that has not been previously
treated with chemotherapy.
- Prior treatment with fluorouracil (5-FU) or GEM administered as a radiation
sensitizer during and up to 4 weeks after radiation therapy is allowed
- If a subject received adjuvant therapy, tumor recurrence or disease progression
must have occurred at least 6 months after completing the last dose of the
adjuvant therapy.
- Subjects whose disease progressed on prior treatment with Nab-P and GEM are not
eligible.
- Subject has a measurable lesion(s) on at least 1 metastatic site based on RECIST 1.1
within 28 days prior to randomization. For subjects with only 1 measurable lesion and
prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must
have documented progression following radiation therapy.
- Subject's tumor sample has CLDN18.2 expression in = 75% of tumor cells demonstrating
moderate to strong membranous staining as determined by central immunohistochemistry
(IHC) testing
- Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subject has predicted life expectancy = 12 weeks.
- Subject must meet all of the following criteria based on the laboratory tests that
will be collected within 14 days prior to randomization. In case of multiple
laboratory data within this period, the most recent data should be used.
- Hemoglobin = 9 g/dl (no transfusion within 14 days of start of study treatment)
- Absolute neutrophil count = 1.5 x 10^9/L
- Platelets = 100 x 10^9/L
- Albumin = 2.5 g/dL
- Total bilirubin = 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN
without liver metastases (= 5 x ULN if liver metastases are present)
- Estimated creatinine clearance = 30 mL/min
- Prothrombin time/international normalized ratio (INR) and partial thromboplastin
time = 1.5 x ULN (except for subjects receiving anticoagulation therapy)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subject has received other investigational treatment within 28 days prior to
randomization.
- Subject has received radiotherapy for metastatic pancreatic adenocarcinoma = 14 days
prior to randomization and has not recovered from any related toxicity.
- Subject has received systemic immunosuppressive therapy, including systemic
corticosteroids within 14 days prior to randomization. Subject using a physiologic
replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day
of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of
systemic corticosteroids or receiving systemic corticosteroids as premedication for
radiologic imaging contrast use are allowed.
- Subject has prior severe allergic reaction or intolerance to known ingredients of
zolbetuximab or other monoclonal antibody, including humanized or chimeric antibodies.
- Subject has known immediate or delayed hypersensitivity, intolerance or
contraindication to any component of study treatment.
- Subject has a known history of a positive test for human immunodeficiency virus
infection or known active hepatitis B (positive HBs antigen [Ag]) or hepatitis C
infection. NOTE: Screening for these infections should be conducted per local
requirements.
1. For subjects who are negative for HBs Ag, but hepatitis B core antibody positive,
a hepatitis B virus DNA test will be performed and if positive, the subject will
be excluded.
2. Subjects with positive hepatitis C serology but negative hepatitis C virus RNA
test results are eligible.
3. Subjects treated for hepatitis C with undetectable viral load results are
eligible.
- Subject has a history of interstitial pneumonia or pulmonary fibrosis.
- Subject has pleural effusion or ascites = Grade 3.
- Subject has an active autoimmune disease that has required systemic treatment in the
past 3 months prior to randomization.
- Subject has active infection requiring systemic therapy that has not completely
resolved per investigator judgment within 7 days prior to randomization.
- Subject has significant cardiovascular disease, including:
- Congestive heart failure (defined as New York Heart Association Class III or IV),
myocardial infarction, unstable angina, coronary angioplasty, coronary stenting,
coronary artery bypass graft, cerebrovascular accident or hypertensive crisis
within 6 months prior to randomization;
- History of clinically significant ventricular arrhythmias (i.e., sustained
ventricular tachycardia, ventricular fibrillation or Torsades de Pointes);
- QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female
subjects;
- Cardiac arrhythmias requiring anti-arrhythmic medications (Subjects with rate
controlled atrial fibrillation for > 1 month prior to randomization.)
- Subject has a history of central nervous system metastases and/or carcinomatous
meningitis from pancreatic adenocarcinoma.
- Subject has known peripheral sensory neuropathy = Grade 2 unless the absence of deep
tendon reflexes is the sole neurological abnormality.
- Subject has had a major surgical procedure = 28 days prior to randomization.
- Subject without complete recovery from a major surgical procedure = 14 days prior to
randomization.
- Psychiatric illness or social situations that would preclude study compliance.
- Subject has another malignancy for which treatment is required.
- Subject has any concurrent disease, infection or co-morbid condition that interferes
with the ability of the subject to participate in the study, which places the subject
at undue risk or complicates the interpretation of data.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/03/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/04/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
393
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Site AU61008 - Gosford
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Recruitment hospital [2]
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Site AU61007 - Wollongong
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Recruitment hospital [3]
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Site AU61005 - Fitzroy
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Recruitment hospital [4]
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Site AU61006 - Warrnambool
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Recruitment postcode(s) [1]
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NSW 2250 - Gosford
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Recruitment postcode(s) [2]
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HVGM+3C - Wollongong
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Recruitment postcode(s) [3]
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5XRF+WX - Fitzroy
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Recruitment postcode(s) [4]
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VIC 3280 - Warrnambool
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Connecticut
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United States of America
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State/province [3]
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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State/province [6]
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Kentucky
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United States of America
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State/province [7]
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Louisiana
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United States of America
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Missouri
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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State/province [14]
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Washington
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Country [15]
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Brazil
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State/province [15]
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Rio Grande Do Sul
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Country [16]
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Brazil
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State/province [16]
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Centro Passo Fundo
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Brazil
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State/province [17]
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Santa Catarina
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Brazil
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State/province [18]
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Sao Paulo
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Country [19]
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China
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State/province [19]
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Beijing
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China
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Changchun
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Country [21]
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China
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State/province [21]
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Chongqing
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China
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Guangdong
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Country [23]
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China
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State/province [23]
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Guangzhou
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Country [24]
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China
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State/province [24]
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Harbin
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Country [25]
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China
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State/province [25]
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Hubei
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Country [26]
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China
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State/province [26]
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Jiangsu
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Country [27]
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China
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State/province [27]
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Shan XI
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Country [28]
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China
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State/province [28]
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Shandong
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Country [29]
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China
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State/province [29]
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Shanghai
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Country [30]
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China
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State/province [30]
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Tianjin
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Country [31]
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China
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State/province [31]
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Xinjiang
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Country [32]
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China
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State/province [32]
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Zhejiang
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Country [33]
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China
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State/province [33]
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Zhengzhou
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Country [34]
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France
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State/province [34]
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Besancon Cedex
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Country [35]
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France
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State/province [35]
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Brest Cedex
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Country [36]
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France
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State/province [36]
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Cedex 5
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Country [37]
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France
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State/province [37]
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Cedex 9
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Country [38]
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France
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State/province [38]
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Herblain Cedex
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Country [39]
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France
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State/province [39]
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Loir-et-Cher
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France
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State/province [40]
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Nancy Cedex
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France
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State/province [41]
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Normandy
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Country [42]
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France
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State/province [42]
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Pessac
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Country [43]
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France
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State/province [43]
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Villejuif Cedex
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Country [44]
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France
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State/province [44]
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Bayonne Cedex
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Country [45]
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France
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State/province [45]
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Bordeaux
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France
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State/province [46]
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Grenoble
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Country [47]
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France
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State/province [47]
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Nice Cedex 2
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Country [48]
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France
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State/province [48]
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Pierre Benite
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Country [49]
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France
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State/province [49]
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Plerin
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Country [50]
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France
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State/province [50]
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Pringy Cedex
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Country [51]
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France
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State/province [51]
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Roche-Sur-Yon
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Country [52]
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France
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State/province [52]
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Strasbourg
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Country [53]
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Ireland
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State/province [53]
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Dublin
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Country [54]
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Italy
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State/province [54]
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Milan
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Country [55]
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Italy
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State/province [55]
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Torino
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Country [56]
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Italy
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State/province [56]
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Cremona
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Country [57]
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Italy
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State/province [57]
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Lombardia
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Country [58]
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Italy
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State/province [58]
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Toscana
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Country [59]
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Italy
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State/province [59]
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Veneto
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Country [60]
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Japan
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State/province [60]
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Aichi
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Country [61]
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Japan
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State/province [61]
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Chiba
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Country [62]
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Japan
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State/province [62]
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Hokkaido
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Country [63]
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Japan
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State/province [63]
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Kanagawa
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Country [64]
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Japan
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State/province [64]
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Nara
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Country [65]
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Japan
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State/province [65]
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Tokyo
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Country [66]
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Japan
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State/province [66]
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Yamaguchi
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Country [67]
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Japan
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State/province [67]
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Fukuoka
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Country [68]
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Japan
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State/province [68]
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Osaka
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Country [69]
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Japan
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State/province [69]
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Wakayama
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Country [70]
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Korea, Republic of
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State/province [70]
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Gyeonggi-do
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Country [71]
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Korea, Republic of
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State/province [71]
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Daegu
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Country [72]
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Korea, Republic of
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State/province [72]
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Jeollanam-do
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Country [73]
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Korea, Republic of
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State/province [73]
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Seoul
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Country [74]
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Mexico
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State/province [74]
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Distrito Federal
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Country [75]
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Mexico
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State/province [75]
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San Luis Potosi
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Country [76]
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Mexico
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State/province [76]
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Veracruz
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Country [77]
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Spain
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State/province [77]
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Barcelona
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Country [78]
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Spain
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State/province [78]
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Navarra
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Country [79]
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Spain
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State/province [79]
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Caceres
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Country [80]
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Spain
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State/province [80]
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Cordoba
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Country [81]
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Spain
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State/province [81]
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Lleida
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Country [82]
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Spain
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State/province [82]
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Madrid
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Country [83]
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Spain
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State/province [83]
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Malaga
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Country [84]
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Spain
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State/province [84]
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Santander
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Country [85]
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Spain
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State/province [85]
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Santiago de Compostela
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Country [86]
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Taiwan
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State/province [86]
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New Taipei City
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Country [87]
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Taiwan
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State/province [87]
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Taichung City
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Country [88]
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Taiwan
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State/province [88]
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Taipei City
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Country [89]
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Turkey
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State/province [89]
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Ankara
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Country [90]
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Turkey
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State/province [90]
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Diyarbakir
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Country [91]
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Turkey
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State/province [91]
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Istanbul
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Country [92]
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Turkey
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State/province [92]
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Konya
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Astellas Pharma Global Development, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to confirm the recommended phase 2 dose (RP2D) of zolbetuximab
in combination with Nab-P + GEM, determine overall survival and assess the safety and
tolerability of the combination treatment.
This study will also evaluate tumor markers and pharmacokinetics (PK) of zolbetuximab, Nab-P
and GEM, and health-related quality of life (HRQoL).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03816163
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Astellas Pharma Global Development
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03816163
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