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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 : Active, not recruiting
First Posted : October 3, 2018
Last Update Posted : May 3, 2021
Sponsor:
Collaborator:
Zai Lab (Shanghai) Co., Ltd.
Information provided by (Responsible Party):
Five Prime Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE September 14, 2018
First Posted Date  ICMJE October 3, 2018
Last Update Posted Date May 3, 2021
Actual Study Start Date  ICMJE September 14, 2018
Actual Primary Completion Date September 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2021)
Progression-Free Survival (PFS) [ Time Frame: up to approximately 30 months ]
Time from enrollment until the EARLIER OF a. progression or b. death from any cause.
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
Overall Survival (OS) [ Time Frame: up to approximately 46 months ]
Time from enrollment until death from any cause
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2021)
  • Overall Survival (OS) [ Time Frame: Up to approximately 30 months ]
    Time from enrollment until death from any cause
  • Overall response rate (ORR) [ Time Frame: Up to approximately 30 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT)
Official Title  ICMJE 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
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)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double blinded (participant, treating physician)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • Drug: bemarituzumab (FPA144)
    bemarituzumab (FPA144)
  • Drug: Placebo
    Placebo
  • Drug: mFOLFOX6
    mFOLFOX6
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: bemarituzumab (FPA144)
    • Drug: 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.

    Interventions:
    • Drug: Placebo
    • Drug: mFOLFOX6
Publications * Xiang H, Liu L, Gao Y, Ahene A, Macal M, Hsu AW, Dreiling L, Collins H. Population pharmacokinetic analysis of phase 1 bemarituzumab data to support phase 2 gastroesophageal adenocarcinoma FIGHT trial. Cancer Chemother Pharmacol. 2020 Nov;86(5):595-606. doi: 10.1007/s00280-020-04139-4. Epub 2020 Sep 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 4, 2020)
155
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2018)
548
Estimated Study Completion Date  ICMJE May 31, 2022
Actual Primary Completion Date September 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   China,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Poland,   Portugal,   Romania,   Spain,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03694522
Other Study ID Numbers  ICMJE FPA144-004 Phase 2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Five Prime Therapeutics, Inc.
Study Sponsor  ICMJE Five Prime Therapeutics, Inc.
Collaborators  ICMJE Zai Lab (Shanghai) Co., Ltd.
Investigators  ICMJE Not Provided
PRS Account Five Prime Therapeutics, Inc.
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP