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Futibatinib in Patients With Specific FGFR Aberrations

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Brief Summary

The purpose of this study is to evaluate the efficacy and safety of futibatinib in patients with FGFR aberrations in 3 distinct cohorts. Patients will be enrolled into one of 3 cohorts: patients with advanced, metastatic or locally-advanced solid tumors harboring FGFR1-4 rearrangements (excluding primary brain tumors and intrahepatic cholangiocarcinoma [iCCA]); patients with gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification; and patients with myeloid or lymphoid neoplasms with FGFR1 rearrangements.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Known FGFR aberration status and tumor type that meet all of the criteria for 1 of the following cohorts: a. Cohort A i. Histologically-confirmed, locally-advanced, advanced, or metastatic solid tumors harboring a FGFR1-4 ii. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 iii. Had disease progression/recurrence after standard treatment for their cancer b. Cohort B i. Histologically-confirmed, locally-advanced, advanced, or metastatic gastric or gastroesophageal junction cancer harboring a FGFR2 amplification. ii. Measurable disease per RECIST 1.1 iii. Received at least 2 prior systemic regimens for advanced/metastatic disease iv. Experienced disease progression/recurrence during or after the most recent prior systemic treatment for advanced/metastatic gastric cancer or GEJ cancer c. Cohort C i. Confirmed myeloid or lymphoid neoplasms as defined by WHO criteria with a FGFR1 rearrangement ii. Not a candidate for hematological stem cell transplant (HSCT) or relapsed after HSCT and donor lymphocyte infusion, and progressed and not a candidate for other therapies

Exclusion Criteria:

  • History and/or current evidence of any of the following disorders:
    • Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator
    • Ectopic mineralization/calcification including, but not limited to, soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant in the opinion of the Investigator
    • Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant in the opinion of the Investigator.
  • Prior treatment with an FGFR inhibitor
  • Brain metastases that are untreated or clinically or radiologically unstable (that is, have been stable for <1 month)

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Study Stats
Protocol No.
20-000720
Category
Hematology-Oncology
Oncology
Contact
CHRISTOPHER LIM
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT04189445
For detailed technical eligibility, visit ClinicalTrials.gov.