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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
Sponsor:
Collaborator:
Zai Lab (Shanghai) Co., Ltd.
Information provided by (Responsible Party):
Five Prime Therapeutics, Inc.

Study Description
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Brief Summary:
This is a global, randomized, double-blind, controlled study to evaluate the efficacy of bemarituzumab (FPA144) + mFOLFOX6 versus placebo + mFOLFOX6 in patients with FGFR2 selected Gastric Cancer (as determined by prospective IHC FGFR2b overexpression and/or a ctDNA blood assay demonstrating FGFR2 gene amplification)

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: bemarituzumab (FPA144) Drug: Placebo Drug: mFOLFOX6 Phase 3

Detailed Description:
The main purpose of this study is to evaluate the efficacy of bemarituzumab (FPA144), which is a targeted antibody, in combination with modified FOLFOX6 compared to placebo in combination with modified FOLFOX6 in participants with Gastric Cancer as measured by overall survival.

Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: up to approximately 46 months ]
    Time from enrollment until death from any cause


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
Contact: Medical Lead (844) 333-5349 FPA144004@fiveprime.com

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Sponsors and Collaborators
Five Prime Therapeutics, Inc.
Zai Lab (Shanghai) Co., Ltd.
More Information
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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