A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT) (FIGHT)
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ClinicalTrials.gov Identifier: NCT03694522 |
Recruitment Status :
Recruiting
First Posted : October 3, 2018
Last Update Posted : February 4, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastric Cancer | Drug: bemarituzumab (FPA144) Drug: Placebo Drug: mFOLFOX6 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 548 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Masking Description: | Double blinded (participant, treating physician) |
Primary Purpose: | Treatment |
Official Title: | FIGHT: A Phase 3 Randomized, Double-Blind, Controlled Study Evaluating Bemarituzumab (FPA144) and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 3 Preceded by Dose-Finding in Phase 1 |
Actual Study Start Date : | September 14, 2018 |
Estimated Primary Completion Date : | July 1, 2022 |
Estimated Study Completion Date : | July 1, 2024 |

Arm | Intervention/treatment |
---|---|
Active Comparator: bemarituzumab (FPA144)+mFOLFOX6
15mg/kg of bemarituzumab (FPA144) given intravenously and mFOLFOX6 administered after the end of the bemarituzumab (FPA144) infusion *Cycle 1 will consist of a one-time dose of 7.5 mg/kg of bemarituzumab (FPA144) given intravenously on Day 8 Treatment is repeated every 2 weeks. |
Drug: bemarituzumab (FPA144)
bemarituzumab (FPA144) Drug: mFOLFOX6 mFOLFOX6 |
Placebo Comparator: Placebo+mFOLFOX6
Placebo given intravenously and mFOLFOX6 administered after the end of the placebo infusion * Cycle 1 will consist of a one-time dose of placebo given intravenously on Day 8 Treatment is repeated every 2 weeks. |
Drug: Placebo
Placebo Drug: mFOLFOX6 mFOLFOX6 |
- Overall Survival (OS) [ Time Frame: up to approximately 46 months ]Time from enrollment until death from any cause
- Progression-free survival (PFS) [ Time Frame: Up to approximately 46 months ]time from enrollment until the EARLIER OF a. progression or b. death from any cause.
- Overall response rate (ORR) [ Time Frame: Up to approximately 46 months ]Proportion of patients with partial or complete response based on assessment of tumor lesions per RECIST v1.1
- Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03 [ Time Frame: Through completion of study treatment, an average of 1 year ]Treatment-Emergent Adverse Events (TEAEs) classified by MedDRA preferred term and assessed by CTCAE.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- 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
- FGFR2b overexpression as determined by a centrally performed IHC tissue test and/or FGFR2 gene amplification as determined by a centrally performed ctDNA blood based assay
- Candidate for mFOLFOX6 chemotherapy
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 HER2
- Women who are pregnant or breastfeeding
Note: Other protocol defined Inclusion/Exclusion criteria may apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694522
Contact: Medical Lead | (844) 333-5349 | FPA144004@fiveprime.com |

Responsible Party: | Five Prime Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT03694522 History of Changes |
Other Study ID Numbers: |
FPA144-004 Phase 3 |
First Posted: | October 3, 2018 Key Record Dates |
Last Update Posted: | February 4, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |