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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/NCT03694522
Registration number
NCT03694522
Ethics application status
Date submitted
14/09/2018
Date registered
3/10/2018
Date last updated
28/02/2024
Titles & IDs
Public title
A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer
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Scientific title
FIGHT: A Phase 2 Randomized, Double-Blind, Controlled Study Evaluating Bemarituzumab (FPA144) and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Preceded by Dose-Finding in Phase 1
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Secondary ID [1]
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2017-003507-22
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Secondary ID [2]
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FPA144-004 Phase 2
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Universal Trial Number (UTN)
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Trial acronym
FIGHT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer
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Condition category
Condition code
Cancer
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Stomach
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Bemarituzumab
Treatment: Drugs - Placebo
Treatment: Drugs - Modified FOLFOX6
Experimental: Bemarituzumab + mFOLFOX6 - Participants received 15 mg/kg bemarituzumab administered every 2 weeks (Q2W) with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Placebo Comparator: Placebo + mFOLFOX6 - Participants received placebo for bemarituzumab administered every 2 weeks with a single additional placebo dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Other interventions: Bemarituzumab
Administered by intravenous infusion over approximately 30 minutes
Treatment: Drugs: Placebo
Administered by intravenous infusion over approximately 30 minutes
Treatment: Drugs: Modified FOLFOX6
mFOLFOX6 regimen consists of the following:
Oxaliplatin 85 mg/m² IV infusion over 120 minutes
Leucovorin 400 mg/m² IV infusion over 120 minutes, or 200 mg/m² levo-leucovorin if leucovorin is unavailable
5-fluorouracil (5-FU) 400 mg/m² bolus over approximately 5 minutes then 5-FU 2400 mg/m² as a continuous IV infusion over approximately 48 hours
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Intervention code [1]
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Other interventions
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Intervention code [2]
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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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Progression-Free Survival (PFS)
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Assessment method [1]
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PFS was defined as time from randomization until the date of radiographic disease progression based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death from any cause, whichever came first. PFS was analyzed using Kaplan-Meier methods. Participants with no progression or death, or who started new anticancer therapy before documented progression or death without documented progression, or who had = 2 consecutive missing tumor assessments before documented progression or death without documented progression were censored on the date of last adequate tumor assessment. Participants with no baseline tumor assessment, were censored at the date of randomization.
The primary efficacy analysis was pre-specified to be conducted after at least 84 PFS events were observed.
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Timepoint [1]
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From randomization until the primary analysis data cut-off date of 23 September 2020; median time on follow-up was 10.9 months.
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as time from randomization until death from any cause. Participants who were lost to follow-up or did not have a date of death were censored at the last date that they were known to be alive. Participants with confirmed death or alive status after the data cutoff date were censored at the data cutoff date. Median OS was estimated using a Kaplan-Meier analysis.
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Timepoint [1]
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From randomization until the primary analysis data cut-off date of 23 September 2020; median time on follow-up was 10.9 months.
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Secondary outcome [2]
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Overall Response Rate (ORR)
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Assessment method [2]
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Tumor response assessment was performed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines. ORR is defined as the percentage of participants who achieved a best overall response (BOR) of either complete response (CR) or partial response (PR) based on investigator assessment of tumor lesions per RECIST v1.1.
CR was defined as the disappearance of all lesions except lymph node short axis < 10 mm; PR was defined as a = 30% reduction in sum of diameters in target lesions.
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Timepoint [2]
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Tumor assessments were performed every 8 weeks until 12 months and then every 12 weeks thereafter until disease progression or additional anticancer therapy was initiated; the median duration of follow-up time was 10.9 months.
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Secondary outcome [3]
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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Assessment method [3]
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TEAEs are defined as adverse events (AEs) that started or worsened from the start of study drug to 28 days after permanent discontinuation of study drug.
A serious AE is defined as any untoward medical occurrence that:
Resulted in death;
Was life-threatening;
Required inpatient hospitalization or prolongation of existing hospitalization;
Resulted in persistent or significant disability or incapacity;
Was a congenital anomaly or birth defect.
The investigator assessed the causality/relationship between study treatment and each AE, and assessed the severity of each AE according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0 on a scale from mild (Grade 1), moderate (Grade 2), severe (Grade 3), life-threatening (Grade 4), or death due to the AE (Grade 5). Cornea and retina AEs were defined by Standardized Medical Dictionary for Regulatory Activities Queries (SMQs) of corneal disorders and retinal disorders (broad).
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Timepoint [3]
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From first dose of study drug to 28 days after last dose of study drug. Actual median (min, max) duration of treatment emergent period was 29 (4.1, 157) weeks in the bemarituzumab + mFOLFOX6 group and 28 (4.3, 133) weeks in the placebo + mFOLFOX6 group.
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Eligibility
Key inclusion criteria
Key
- Histologically documented gastric or gastroesophageal junctional adenocarcinoma (not
amenable to curative therapy)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate hematological, liver and kidney function. Measurable or non-measurable, but
evaluable disease using RECIST v1.1
- Fibroblast growth factor receptor 2b (FGFR2b) overexpression as determined by a
centrally performed immunohistochemistry tissue test and/or FGFR2 gene amplification
as determined by a centrally performed circulating tumor deoxyribonucleic acid (ctDNA)
blood based assay
- Candidate for mFOLFOX6 chemotherapy
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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
- Untreated or symptomatic central nervous system (CNS) metastases
- Clinically significant cardiac disease,
- Peripheral sensory neuropathy >/= Common Terminology Criteria for Adverse Events
(CTCAE) Grade 2
- Active infection requiring systemic treatment
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
(AIDS)-related illness, or known active or chronic hepatitis B or C infection
- Prior treatment with any selective inhibitor of the fibroblast growth factor
(FGF)-FGFR pathway
- Known abnormalities of the cornea that may pose an increased risk of developing a
corneal ulcer
- Known positivity for human epidermal growth factor receptor 2 (HER2)
- Women who are pregnant or breastfeeding
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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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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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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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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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
14/09/2018
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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
13/05/2022
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Sample size
Target
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Accrual to date
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Final
155
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Chris O'brien Lifehouse - Camperdown
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The Townsville Hospital - Douglas
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Sydney Adventist Hospital - Wahroonga
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- Camperdown
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- Douglas
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- Wahroonga
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Spain
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Girona
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Spain
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Lleida
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Spain
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Madrid
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Spain
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Majadahonda
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Spain
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Pamplona
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Spain
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Sabadell
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Spain
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Servilla
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Spain
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Terrassa
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Taiwan
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Taichung
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Thailand
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Bankok
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Thailand
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Chiang Rai
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Thailand
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Hat Yai
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Thailand
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Khon Kaen
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Thailand
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Lampang
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Atakum
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Turkey
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Aydin
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Turkey
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Bursa
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Turkey
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Gaziantep
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Turkey
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Istanbul
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Izmir
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Malatya
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Van
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United Kingdom
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Dundee
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Five Prime Therapeutics, Inc.
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Zai Lab (Shanghai) Co., Ltd.
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Summary
Brief summary
The main objective of the Phase 2 part of the study is to evaluate the efficacy of
bemarituzumab (FPA144), a targeted antibody, in combination with modified FOLFOX6 compared to
placebo in combination with modified FOLFOX6 in participants with advanced gastrointestinal
cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03694522
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Contacts
Principal investigator
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MD
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Amgen
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03694522
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