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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03504397




Registration number
NCT03504397
Ethics application status
Date submitted
12/04/2018
Date registered
20/04/2018

Titles & IDs
Public title
A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer
Scientific title
A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Secondary ID [1] 0 0
2017-002567-17
Secondary ID [2] 0 0
8951-CL-0301
Universal Trial Number (UTN)
Trial acronym
Spotlight
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer 0 0
Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer 0 0
Metastatic Gastric Adenocarcinoma or Cancer 0 0
Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - zolbetuximab
Treatment: Drugs - placebo
Treatment: Drugs - oxaliplatin
Treatment: Drugs - folinic acid
Treatment: Drugs - fluorouracil

Experimental: Arm A (zolbetuximab plus mFOLFOX6) - Participants will receive a loading dose of zolbetuximab at Cycle 1 Day 1 followed by a lower dose in subsequent cycles every 3 weeks. Additionally, participants will receive up to 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 or more cycles (each cycle is approximately 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. After 12 mFOLFOX6 treatments, participants may continue to receive fluorouracil (5-FU) and folinic acid at the investigator's discretion until the subject meets study treatment discontinuation criteria.

Placebo comparator: Arm B (Placebo plus mFOLFOX6) - Participants will receive placebo starting at Cycle 1 Day 1 and every 3 weeks thereafter. Additionally, participants will receive up to 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 or more cycles (each cycle is approximately 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. After 12 mFOLFOX6 treatments, participants may continue to receive fluorouracil (5-FU) and folinic acid at the investigator's discretion until the subject meets study treatment discontinuation criteria.


Treatment: Drugs: zolbetuximab
Zolbetuximab will be administered as a minimum 2-hour IV infusion.

Treatment: Drugs: placebo
Placebo will be administered as a minimum 2-hour IV infusion.

Treatment: Drugs: oxaliplatin
Oxaliplatin will be administered as a 2-hour IV infusion

Treatment: Drugs: folinic acid
Folinic acid will be administered as a 2-hour IV infusion.

Treatment: Drugs: fluorouracil
Fluorouracil will be administered as IV bolus over 5-15 minutes and continuous IV infusion over 46-48 hours.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Up to 13 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 23 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to 13 months
Secondary outcome [3] 0 0
Duration Of Response (DOR)
Timepoint [3] 0 0
Up to 13 months
Secondary outcome [4] 0 0
Safety and tolerability assessed by adverse events (AEs)
Timepoint [4] 0 0
Up to 16 months
Secondary outcome [5] 0 0
Number of participants with laboratory assessments abnormalities and or adverse events
Timepoint [5] 0 0
Up to 14 months
Secondary outcome [6] 0 0
Number of participants with vital signs abnormalities and or adverse events
Timepoint [6] 0 0
Up to 14 months
Secondary outcome [7] 0 0
Number of participants with electrocardiograms (ECG) abnormalities and or adverse events
Timepoint [7] 0 0
Up to 14 months
Secondary outcome [8] 0 0
Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events
Timepoint [8] 0 0
Up to 13 months
Secondary outcome [9] 0 0
Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer (EORTC-QLQ-C30) questionnaire
Timepoint [9] 0 0
Up to 16 months
Secondary outcome [10] 0 0
HRQoL measured by the QLQ-OG25 questionnaire
Timepoint [10] 0 0
Up to 16 months
Secondary outcome [11] 0 0
HRQoL measured by the Global Pain (GP) questionnaire
Timepoint [11] 0 0
Up to 16 months
Secondary outcome [12] 0 0
HRQoL measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) questionnaire
Timepoint [12] 0 0
Up to 16 months
Secondary outcome [13] 0 0
Time to confirmed deterioration (TTCD)
Timepoint [13] 0 0
Up to 16 months
Secondary outcome [14] 0 0
PK of zolbetuximab: Concentration Immediately Prior to Dosing at multiple dosing (Ctrough)
Timepoint [14] 0 0
Up to 16 months
Secondary outcome [15] 0 0
Number of anti-drug antibody (ADA) Positive Participants
Timepoint [15] 0 0
Up to 16 months

Eligibility
Key inclusion criteria
* Female subject eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin and a demonstrated non-pregnant status through additional testing are eligible) and at least one of the following conditions applies:

* Not a woman of child-bearing potential (WOCBP) OR
* WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs
* 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 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs.
* A sexually active male subject with a female partner(s) who is 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.
* Male subject must agree not to donate sperm starting at screening and throughout the study period, and for 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 has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.
* Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization.
* Subject has radiologically evaluable disease (measurable and/or non-measurable disease according to RECIST 1.1), per local assessment, = 28 days prior to randomization. For subjects with only 1 evaluable lesion and prior radiotherapy = 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.
* Subject's tumor expresses CLDN18.2 in = 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing.
* Subject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen. (Unique to China: Subject has a known HER2-negative gastric or GEJ tumor.)
* Subject has ECOG performance status 0 to 1.
* Subject has predicted life expectancy = 12 weeks.
* Subject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility.

* Hemoglobin (Hgb) = 9 g/dL. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb = 9 g/dL.
* Absolute neutrophil count (ANC) = 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) without liver metastases (or < 3.0 x ULN if liver metastases are present)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN without liver metastases (or = 5 x ULN if liver metastases are present)
* Estimated creatinine clearance = 30 mL/min
* Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) = 1.5 x ULN (except for subjects receiving anticoagulation therapy)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subject has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies, as long as it was completed at least 6 months prior to randomization. Subject may have received treatment with herbal medications that have known antitumor activity > 28 days prior to randomization.
* Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ 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. Subjects 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 received other investigational agents or devices within 28 days prior to randomization.
* Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies.
* Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment.
* Subject has prior severe allergic reaction or intolerance to any component of mFOLFOX6.
* Subject has known dihydropyrimidine dehydrogenase deficiency.
* Subject has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.
* Subject has significant gastric bleeding and/or untreated gastric ulcers that would exclude the subject from participation.
* Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen (HBs Ag)) or C infection. NOTE: Screening for these infections should be conducted per local requirements.

* For subjects who are negative for HBs Ag, but hepatitis B core antibody (HBc Ab) positive, an HB deoxyribonucleic acid (DNA) test will be performed and if positive, the subject will be excluded.
* Subjects with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test are eligible.
* Subjects treated for HCV with undetectable viral load results are eligible.
* Subject has an active autoimmune disease that has required systemic treatment within the past 3 months prior to randomization.
* Subject has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization.
* Subject has significant cardiovascular disease, including any of the following:

* Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident (CVA) 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
* History or family history of congenital long QT syndrome
* Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial fibrillation for > 1 month prior to randomization are eligible).
* Subject has a history of central nervous system metastases and/or carcinomatous meningitis from gastric/GEJ cancer.
* Subject has known peripheral sensory neuropathy > Grade 1 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 is without complete recovery from a major surgical procedure = 14 days prior to randomization.
* Subject has 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 comorbid 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
Accrual to date
Final
566
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Site AU61002 - Douglas
Recruitment hospital [2] 0 0
Site AU61011 - Tugun
Recruitment hospital [3] 0 0
Site AU61008 - Adelaide
Recruitment hospital [4] 0 0
Site AU61006 - East Bentleigh
Recruitment hospital [5] 0 0
Site AU61007 - Kogarah
Recruitment postcode(s) [1] 0 0
4814 - Douglas
Recruitment postcode(s) [2] 0 0
4224 - Tugun
Recruitment postcode(s) [3] 0 0
5011 - Adelaide
Recruitment postcode(s) [4] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [5] 0 0
2217 - Kogarah
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Arizona
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California
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Colorado
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Connecticut
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Illinois
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Kentucky
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Maryland
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Washington
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Liege
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Brugge
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Chile
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Santiago
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Chile
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Providencia
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Chile
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China
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China
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Zhejiang
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China
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China
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Hefei
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China
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Xiamen
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China
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Zhengzhou
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Colombia
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Antioquia
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Córdoba
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DC
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Valle
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Cali
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Israel
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Israel
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Israel
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Holon
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Israel
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Israel
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Tel Aviv
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VI
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Ancona
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Bergamo
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Cremona
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Italy
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Milano
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Modena
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Italy
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Padova
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Parma
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Italy
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Perugia
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Italy
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Piacenza
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Italy
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Pisa
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Italy
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Reggio Emilia
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Italy
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Roma
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Italy
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Terni
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Italy
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Turin TO
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Japan
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Aichi
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Chiba
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Ehime
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Hokkaido
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Hyogo
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Osaka
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Japan
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Saitama
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Shizuoka
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Japan
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Tokyo
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Japan
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Fukuoka
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Korea, Republic of
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Gyeonggi-do
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Gyeonggido [Kyonggi-do]
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Mexico
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Distrito Federal
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Mexico
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Veracruz
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Mexico
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Aguascalientes
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Mexico
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Jalisco
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Mexico
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Oaxaca
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Mexico
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San Luis De Potosi
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Peru
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Lima
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Peru
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Arequipa
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Poland
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Lubuskie
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Poland
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Mazowieckie
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Poland
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Podkarpackie
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Poland
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Warszawa
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Spain
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Barcelona
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Spain
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Castilla Y Leon
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Spain
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Madrid
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Spain
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Burgos
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Spain
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Murcia
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Spain
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Sevilla
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Spain
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Zaragoza
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Taiwan
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Taoyuan
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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United Kingdom
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Aberdeenshire
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United Kingdom
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London, City Of
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United Kingdom
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Surrey
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United Kingdom
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Cambridge
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United Kingdom
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Coventry
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United Kingdom
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Dundee
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Leeds
Country [151] 0 0
United Kingdom
State/province [151] 0 0
London
Country [152] 0 0
United Kingdom
State/province [152] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Global Development, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Medical Lead
Address 0 0
Astellas Pharma Global Development, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Available to whom?
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com/


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/NCT03504397