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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04807972
Registration number
NCT04807972
Ethics application status
Date submitted
17/03/2021
Date registered
19/03/2021
Titles & IDs
Public title
Study to Evaluate Adverse Events and Change in Disease Activity When Intravenous (IV) Infusion of ABBV-927 is Administered in Combination With IV Modified FOLFIRINOX (mFFX) With or Without IV Budigalimab Compared to mFFX in Adult Participants With Untreated Pancreatic Cancer Metastasis
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Scientific title
A Phase 1b/2, Randomized, Controlled, Open-Label Study Evaluating the Safety and Efficacy of ABBV-927 Administered in Combination With Modified FOLFIRINOX (mFFX) With or Without Budigalimab Compared to mFFX in Subjects With Untreated Metastatic Pancreatic Adenocarcinoma
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Secondary ID [1]
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2020-005767-31
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Secondary ID [2]
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M20-732
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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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Condition category
Condition code
Cancer
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Pancreatic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ABBV-927
Treatment: Drugs - Budiglimab
Treatment: Drugs - modified FOLFIRINOX
Experimental: Phase 1b Dose Escalation - Participants will receive escalating doses of ABBV-927 in combination with modified FOLFIRINOX (mFFX) and Budigalimab.
Experimental: Phase 2 Cohort A - Participants will receive modified FOLFIRINOX on Day 1 and Day 15 of each 28 day cycle.
Experimental: Phase 2 Cohort B - Participants will receive modified FOLFIRINOX (Day 1 and Day 15) + ABBV-927 in each 28 day cycle.
Experimental: Phase 2 Cohort C Expansion - Participants will receive modified FOLFIRINOX (Day 1 and Day 15) + ABBV 927 and Budigalimab as Intravenous (IV) Infusion in each 28 day cycle.
Treatment: Drugs: ABBV-927
Intravenous (IV) Infusion
Treatment: Drugs: Budiglimab
Intravenous (IV) Infusion
Treatment: Drugs: modified FOLFIRINOX
Intravenous (IV) 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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Phase 1b: Percentage of participants experiencing Adverse Events
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Assessment method [1]
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An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.
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Timepoint [1]
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Up to 6 months
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Primary outcome [2]
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Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Laboratory (Hematological and Chemistry) Values
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Assessment method [2]
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Baseline values and changes from baseline will be summarized for each scheduled post-baseline visit for laboratory data as applicable. If more than one measurement exists for a participant on a particular day and time, an arithmetic average will be calculated. This average will be that participant's measurement for that day. For participants that do not have any post-baseline measurements, only their baseline values will be summarized.
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Timepoint [2]
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Up to 6 months
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Primary outcome [3]
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Phase 1b: Number of Participants with Potentially Clinically Significant (PCS) Vital Signs
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Assessment method [3]
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Baseline values and changes from baseline will be summarized for each scheduled post-baseline visit for vital signs data.
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Timepoint [3]
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Up to 6 months
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Primary outcome [4]
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Phase 1b: Number of Participants with Dose Limiting Toxicities (DLT)
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Assessment method [4]
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A DLT is defined as any serious AE for which a clear alternative cause cannot be established (e.g., attributed to the disease under study, another disease, or to a concomitant medication \[e.g., COVID-19 vaccine\] by the investigator or AbbVie Therapeutic Area (TA) MD\] that occurs during the DLT observation period, and is not listed as a predefined exception in the protocol.
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Timepoint [4]
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Up to 6 months
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Primary outcome [5]
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Phase 2: Overall Survival
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Assessment method [5]
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Overall survival is defined as the time between the date of randomization and death due to any cause.
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Timepoint [5]
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48 months.
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Secondary outcome [1]
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Phase 1b and Phase 2: Maximum Plasma Concentration (Cmax)
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Assessment method [1]
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The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval.
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Timepoint [1]
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Up to approximately 3 months
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Secondary outcome [2]
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Phase 1b and Phase 2: Time to Maximum Observed Plasma Concentration (Tmax)
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Assessment method [2]
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The time to maximum plasma concentration (Tmax; measured in hours) is the time it takes for a drug to achieve Cmax.
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Timepoint [2]
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Up to approximately 3 months
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Secondary outcome [3]
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Phase 1b and Phase 2: Area Under the Concentration-time Curve Over the Time Interval (AUC) in Plasma
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Assessment method [3]
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The area under the plasma concentration-time curve (AUC; measured in ng\*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma.
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Timepoint [3]
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Up to approximately 3 months.
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Secondary outcome [4]
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Phase 1b and Phase 2: Objective Response Rate (ORR)
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Assessment method [4]
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ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) per investigator assessment according to RECIST version 1.1.
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Timepoint [4]
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Up to approximately 27 months
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Secondary outcome [5]
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Phase 1b and Phase 2: Clinical Benefit Rate (CBR)
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Assessment method [5]
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Clinical Benefit Rate (CBR) is defined as the percentage of participants whose best overall response is either Complete Response (CR), Partial Response (PR), or stable disease (SD) according to RECIST version 1.1.
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Timepoint [5]
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Up to approximately 27 months
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Secondary outcome [6]
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Phase 1b and Phase 2: Duration of Response (DOR) for Participants Who Achieve a Documented Confirmed Response of CR/PR
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Assessment method [6]
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DOR is defined as the time from the initial response of CR/PR per investigator review according to RECIST version 1.1 criteria to the first occurrence of radiographic disease progression, clinical progression or death from any cause whichever occurs first.
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Timepoint [6]
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Up to approximately 27 months
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Secondary outcome [7]
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Phase 1b and Phase 2: Progression Free Survival (PFS)
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Assessment method [7]
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PFS is defined as the time from randomization to a documented radiographic disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, clinical progression or death from any cause, whichever occurs earlier.
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Timepoint [7]
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Up to approximately 24 months after study drug discontinuation
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Secondary outcome [8]
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Phase 1b and Phase 2: Quality of Life(QoL)-Measure Participant Overall Perceptions of Their Change in Pancreatic Cancer Symptoms includes the Patient Global Impression of Severity (PGIS) and the the Patient Global Impression of Change (PGIC)
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Assessment method [8]
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Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) will measure participants' overall perceptions of their pancreatic cancer symptoms over time.
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Timepoint [8]
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Up to approximately 25 months
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Secondary outcome [9]
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Phase 2: Percentage of Participants Experiencing Adverse Events
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Assessment method [9]
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An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
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Timepoint [9]
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Up to approximately 27 months.
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Eligibility
Key inclusion criteria
* Body weight >= 35 kg.
* Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with metastatic disease.
* Measurable disease per Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1).
* Prior history of or clinically stable concurrent malignancy are eligible for enrollment provided the malignancy is clinically insignificant, no treatment is required, and the participant is clinically stable.
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Minimum age
18
Years
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Maximum age
75
Years
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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
* Participants with locally advanced disease.
* Participants with neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.
* Prior radiotherapy, surgery, or systemic anti-cancer therapy for the treatment of metastatic pancreatic adenocarcinoma.
* Prior radiotherapy, surgery, or systemic anti-cancer therapy in the adjuvant setting, or earlier, within the last 4 months.
* Prior radiotherapy to any measurable metastatic lesion at any time.
* Clinically significant third-space fluid accumulation (e.g., ascites or pleural effusion).
* Known metastases to the central nervous system (CNS).
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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
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
28/05/2021
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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
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Actual
25/03/2024
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Sample size
Target
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Medical Centre /ID# 231379 - Clayton
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Recruitment hospital [2]
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Austin Health /ID# 231378 - Heidelberg
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3084 - Heidelberg
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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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Colorado
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Country [2]
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United States of America
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State/province [2]
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Maryland
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Country [3]
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United States of America
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State/province [3]
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Ohio
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Country [4]
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United States of America
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State/province [4]
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Pennsylvania
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Country [5]
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Israel
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State/province [5]
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H_efa
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Country [6]
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Israel
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State/province [6]
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Tel-Aviv
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Country [7]
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Korea, Republic of
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State/province [7]
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Seoul Teugbyeolsi
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Country [8]
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Puerto Rico
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State/province [8]
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Rio Piedras
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Country [9]
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Spain
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State/province [9]
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Barcelona
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Country [10]
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Spain
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State/province [10]
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Madrid
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Country [11]
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Spain
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State/province [11]
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Zaragoza
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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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
Metastatic Pancreatic Cancer Disease is one of the most aggressive and deadliest forms of cancer with very poor survival. This study will evaluate adverse events and change in disease activity in participants 18 to 75 years of age with a body weight greater than or equal to 35 kg with Metastatic Pancreatic Cancer Disease treated with Intravenous (IV) infusion of modified FOLFIRINOX (mFFX) combined with IV infusions of ABBV-927 with or without Budigalimab. ABBV-927 and Budigalimab are the investigational drugs being developed for treatment of Metastatic Pancreatic Cancer Disease. In this study, doctors will enroll participants between 18 and 75 years of age with a body weight greater than or equal to 35 kg diagnosed diagnosed with Metastatic Pancreatic Cancer Disease in 4 different groups, called treatment arms. Each group will receive different treatments. Approximately 129 adult participants will be enrolled in the study across approximately 27 sites worldwide. Participants will receive ABBV-927 and Budigalimab as Intravenous (IV) Infusion in Phase 1b and Phase 2 on day 3 of every 28 day cycle, modified FOLFIRINOX as IV Infusion in Phase 1b and Phase 2 on Day1 and Day 15 of every 28 day cycle up to maximum of 2 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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Trial website
https://clinicaltrials.gov/study/NCT04807972
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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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ABBVIE INC.
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Address
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AbbVie
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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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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04807972