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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 Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric 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: mFOLFOX6 + Zolbetuximab - Participants received intravenous (IV) infusion (minimum 2-hour) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle1 day1(C1D1) followed by 600 mg/m\^2 every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received upto 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4/more cycles. mFOLFOX6 was administered on Days 1, 15 \& 29 of each cycle (5-FU:400mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85mg/m\^2 IV infusion over 2 hours) A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants continued to receive 5-FU \& Folinic acid on Days 1, 15 \& 29 of each cycle at the investigator discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.

Placebo comparator: Placebo plus mFOLFOX6 - Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.


Treatment: Drugs: zolbetuximab
Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Each cycle was approximately 42 days.

Treatment: Drugs: placebo
Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C1D22 until participant met study treatment discontinuation criteria. Each cycle was approximately 42 days.

Treatment: Drugs: oxaliplatin
Participants received up to 12 treatments of oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours) on Days 1, 15 and 29 of each cycle.. A maximum of 12 doses of oxaliplatin was permitted. Each cycle was approximately 42 days.

Treatment: Drugs: folinic acid
Participants received up to 12 treatments of folinic acid administered 400 mg/m\^2 IV infusion over 2 hours 4 or more cycles on Days 1, 15 and 29 of each cycle. participants could continue to receive folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.

Treatment: Drugs: fluorouracil
Participants received up to 12 treatments of 5-fluorouracil over 4 or more cycles administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Participants could continue to receive 5-fluorouracil on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
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
From date of randomization until the date of first documented radiological progression or date of death from any cause, whichever occurred first (up to 50 months and 19 days)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From the date of randomization until 63 months
Secondary outcome [2] 0 0
Time to Confirmed Deterioration (TTCD) Using Physical Functioning (PF) as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30)
Timepoint [2] 0 0
From the date of randomization until 51 months
Secondary outcome [3] 0 0
Time to Confirmed Deterioration (TTCD) Using Oesophago-gastric Questionnaire (OG25) on Abdominal Pain and Discomfort as Measured by EORTC QLQ-OG25
Timepoint [3] 0 0
From the date of randomization until 51 months
Secondary outcome [4] 0 0
Time to Confirmed Deterioration (TTCD) Using Global Health Status as Measured by EORTC QLQ-C30
Timepoint [4] 0 0
From the date of randomization until 51 months
Secondary outcome [5] 0 0
Objective Response Rate (ORR)
Timepoint [5] 0 0
From the date of randomization until 51 months
Secondary outcome [6] 0 0
Duration Of Response (DOR)
Timepoint [6] 0 0
From date of first response (CR/PR) until 51 months
Secondary outcome [7] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timepoint [7] 0 0
From first dose until 51 months
Secondary outcome [8] 0 0
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Timepoint [8] 0 0
Baseline, cycle (C) 1 day (D) 22, D1 and D22 of C2 through C30, C31D1, C32D1
Secondary outcome [9] 0 0
Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire
Timepoint [9] 0 0
Baseline, C1D22, D1 and D22 of C2 through C19, C20D1, C21D1, 30 day follow up, 90 day follow up
Secondary outcome [10] 0 0
Change From Baseline in HRQoL Measured by the QLQ-OG25 Questionnaire
Timepoint [10] 0 0
Baseline, C1D22, D1 and D22 of C2 through C19, C20D1, C21D1, 30 day follow up, 90 day follow up
Secondary outcome [11] 0 0
Change From Baseline in HRQoL Measured by Global Pain (GP)
Timepoint [11] 0 0
Baseline, C1D22, D1 and D22 of C2 through C19, C20D1, C21D1, 30 day follow up, 90 day follow up
Secondary outcome [12] 0 0
Change From Baseline in HRQoL Measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) Questionnaire
Timepoint [12] 0 0
Baseline, C1D22, D1 and D22 of C2 through C19, C20D1, C21D1, 30 day follow up, 90 day follow up
Secondary outcome [13] 0 0
Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough)
Timepoint [13] 0 0
Predose on C1D22, C3D1, C5D1, C7D1, C9D1
Secondary outcome [14] 0 0
Number of Participants With Anti-drug Antibodies (ADA)
Timepoint [14] 0 0
Predose on C1D1, C1D22, C3D1, C5D1, C7D1, C9D1, 30-day follow up, 90-day follow up

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
30/09/2025
Actual
Sample size
Target
Accrual to date
Final
565
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
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Colorado
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Connecticut
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Illinois
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Kentucky
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Michigan
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New Jersey
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New York
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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China
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China
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China
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Sachsen
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Dresden
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Heilbronn
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Israel
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HaMerkaz
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Israel
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HaDarom
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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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VI
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Milano
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Padova
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Parma
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Perugia
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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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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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Japan
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Osaka
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Saitama
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Shizuoka
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Tokyo
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State/province [114] 0 0
Fukuoka
Country [115] 0 0
Korea, Republic of
State/province [115] 0 0
Gyeonggi-do
Country [116] 0 0
Korea, Republic of
State/province [116] 0 0
Gyeonggido [Kyonggi-do]
Country [117] 0 0
Korea, Republic of
State/province [117] 0 0
Seoul Teugbyeolsi
Country [118] 0 0
Korea, Republic of
State/province [118] 0 0
Incheon
Country [119] 0 0
Korea, Republic of
State/province [119] 0 0
Seoul
Country [120] 0 0
Mexico
State/province [120] 0 0
Distrito Federal
Country [121] 0 0
Mexico
State/province [121] 0 0
Veracruz
Country [122] 0 0
Mexico
State/province [122] 0 0
Aguascalientes
Country [123] 0 0
Mexico
State/province [123] 0 0
Jalisco
Country [124] 0 0
Mexico
State/province [124] 0 0
Oaxaca
Country [125] 0 0
Mexico
State/province [125] 0 0
San Luis De Potosi
Country [126] 0 0
Peru
State/province [126] 0 0
Lima
Country [127] 0 0
Peru
State/province [127] 0 0
Arequipa
Country [128] 0 0
Poland
State/province [128] 0 0
Lubuskie
Country [129] 0 0
Poland
State/province [129] 0 0
Mazowieckie
Country [130] 0 0
Poland
State/province [130] 0 0
Podkarpackie
Country [131] 0 0
Poland
State/province [131] 0 0
Warszawa
Country [132] 0 0
Spain
State/province [132] 0 0
Barcelona
Country [133] 0 0
Spain
State/province [133] 0 0
Castilla Y Leon
Country [134] 0 0
Spain
State/province [134] 0 0
Madrid
Country [135] 0 0
Spain
State/province [135] 0 0
Burgos
Country [136] 0 0
Spain
State/province [136] 0 0
Murcia
Country [137] 0 0
Spain
State/province [137] 0 0
Sevilla
Country [138] 0 0
Spain
State/province [138] 0 0
Zaragoza
Country [139] 0 0
Taiwan
State/province [139] 0 0
Taoyuan
Country [140] 0 0
Taiwan
State/province [140] 0 0
Kaohsiung
Country [141] 0 0
Taiwan
State/province [141] 0 0
Taichung
Country [142] 0 0
Taiwan
State/province [142] 0 0
Tainan
Country [143] 0 0
Taiwan
State/province [143] 0 0
Taipei
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Aberdeenshire
Country [145] 0 0
United Kingdom
State/province [145] 0 0
London, City Of
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Surrey
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Cambridge
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Coventry
Country [149] 0 0
United Kingdom
State/province [149] 0 0
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


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03504397