TerminatedPhase 2

Futibatinib in Patients With Specific FGFR Aberrations

Stopped: Sponsor made a strategic decision to terminate the study considering enrollment challenges for some of the cohorts in the trial.

United States115 participantsStarted 2020-08-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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:

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)

What they're measuring

Objective Response Rate (ORR) Based on Independent Central Review (IRC) in Cohorts A and B

Timeframe: At the end of every 2 cycles until disease progression (Up to 31 months)

Complete Response (CR) Rate in Cohort C

Timeframe: At the end of every 2 cycles until disease progression (Up to 31 months)

Trial details

NCT IDNCT04189445

SponsorTaiho Oncology, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-11

Results submitted2025-09-19

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