Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

Overview

About this study

The main objective of this study is to compare effectiveness of bemarituzumab combined with oxaliplatin and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adults with unresectable, locally advanced or metastatic gastric or gastroesophageal junction cancer not amenable to curative therapy.
  • Confirmed fibroblast growth factor receptor 2b (FGFR2b) overexpression by immunohistochemistry (IHC) (central testing result).
  • Eastern Cooperative Oncology Group (ECOG) less than or equal to 1.
  • Measurable, evaluable, or non-evaluable disease as long as evaluable by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Participant has no contraindications to mFOLFOX6 chemotherapy.
  • Adequate organ and bone marrow function:
    • absolute neutrophil count greater than or equal to 1.5 times 10^9/L;
    • platelet count greater than or equal to 100 times 10^9/L;
    • hemoglobin greater than or equal to 9 g/dl;
    • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal (ULN) (or less than 5 times ULN if liver involvement).
    • total bilirubin less than 1.5 times ULN (or less than 2 times ULN if liver involvement); with the exception of participants with Gilbert's disease);
    • calculated or measured creatinine clearance (CrCl) of greater than or equal to 30 mL/minute calculated using the formula of Cockcroft and Gault -international normalized ratio (INR) or prothrombin time (PT) less than 1.5 times ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment.

Exclusion Criteria:

  • Prior treatment for metastatic or unresectable disease.
    • Note: prior adjuvant or neo-adjuvant therapy for local disease is allowed if ended more than 6 months of 1st dose.
  • Prior treatment with any selective inhibitor of fibroblast growth factor.
  • ibroblast growth factor receptor (FGF-FGFR) pathway.
  • Known human epidermal growth factor receptor 2 (HER2) positive.
  • Untreated or symptomatic central nervous system (CNS) disease or brain metastases.
  • Peripheral sensory neuropathy greater than or equal to Grade 2.
  • Clinically significant cardiac disease.
  • Other malignancy within the last 2 years (exceptions for definitively treated disease).
  • Chronic or systemic ophthalmological disorders.
  • Major surgery or other investigational study within 28 days prior to first dose of study treatment.
  • Palliative radiotherapy within 14 days prior to the first dose of study treatment.
  • Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer.

Eligibility last updated 10/22/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Harry Yoon, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mohamad Sonbol, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Jason Starr, D.O.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions