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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04189445.
Locations matching your search criteria
United States
Maryland
Baltimore
University of Maryland/Greenebaum Cancer CenterStatus: Active
Contact: Nancy S. Tait
Phone: 410-328-3546
Study TAS-120-202 is an open-label, multinational, 3-arm Phase 2 study evaluating the
efficacy, safety, tolerability, PK, and pharmacodynamics of futibatinib in patients with
FGFR aberrations. Eligible patients will be assigned to 1 of 3 treatment cohorts based on
diagnosis and FGFR gene aberration status.
Patients will receive futibatinib at an oral dose of 20 mg once a day on a continuous
28-day cycle.
The study will enroll approximately:
- Cohort A: 60 patients with locally advanced, advanced, or metastatic solid tumor
harboring FGFR rearrangements other than primary brain tumor or iCCA;
- Cohort B: 35 patients with locally-advanced, advanced, or metastatic gastric cancer
or gastro-esophageal junction (GEJ) with FGFR2 amplification;
- Cohort C: 20 patients with myeloid or lymphoid neoplasms (MLN) with FGFR1
rearrangements
Treatment in all cohorts will continue until disease progression, unacceptable toxicity,
or any other of the criteria for treatment discontinuation is met. For patients who
discontinue treatment for reasons other than disease progression, tumor assessments
should be continued until radiologic disease progression is documented or until
initiation of subsequent new anticancer therapy (whichever occurs first).
Patients will be followed for survival every 12 weeks (±2 weeks) until survival events
(deaths) have been reported for 75% of enrolled patients or the study is terminated early
by the Sponsor.
Additional cohorts may be added in the future in case of new emerging efficacy data.
Lead OrganizationTaiho Pharmaceutical Company Limited
