Futibatinib in Patients With Specific FGFR Aberrations
Megadott ok: Sponsor made a strategic decision to terminate the study considering enrollment challenges for some of the cohorts in the trial.
Key facts
- Where
- Baltimore, Boston, Chicago, Gilbert, Houston, Los Angeles, Oklahoma City, Philadelphia, Washington D.C. és Woodhaven, Egyesült ÁllamokSee the 11 sites
- Phase
- 2. fázis
Where in Egyesült Államok
- University of MarylandBaltimore, Egyesült ÁllamokNo longer taking part
- Beth Israel Deaconess Medical CenterBoston, Egyesült ÁllamokNo longer taking part
- University of Chicago Comprehensive Cancer CenterChicago, Egyesült ÁllamokNo longer taking part
- Banner MD Anderson Cancer CenterGilbert, Egyesült ÁllamokNo longer taking part
- Houston Methodist Cancer CenterHouston, Egyesült ÁllamokNo longer taking part
- The University of Texas M. D. Anderson Cancer CenterHouston, Egyesült ÁllamokNo longer taking part
- UCLA Medical CenterLos Angeles, Egyesült ÁllamokNo longer taking part
- Mercy Clinic Oncology and Hematology - ColettaOklahoma City, Egyesült ÁllamokNo longer taking part
- Fox Chase Cancer CenterPhiladelphia, Egyesült ÁllamokNo longer taking part
- Georgetown University - Lombardi Comprehensive Cancer CenterWashington D.C., Egyesült ÁllamokNo longer taking part
- Henry Ford HospitalWoodhaven, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Taiho Oncology, Inc.
- Trial code
- NCT04189445
- Record updated
- 2025. október 8.
- Original description
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.Read full original descriptionShow less
A Phase 2 Study of Futibatinib in Patients With Specific FGFR Aberrations
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.
Inclusion: 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:; Cohort A; Histologically-confirmed, locally-advanced, advanced, or metastatic solid tumors harboring a FGFR1-4; Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; Had disease progression/recurrence after standard treatment for their cancer; Cohort B; Histologically-confirmed, locally-advanced, advanced, or metastatic gastric or gastroesophageal junction cancer harboring a FGFR2 amplification; Measurable disease per RECIST 1.1; Received at least 2 prior systemic regimens for advanced/metastatic disease; Experienced disease progression/recurrence during or after the most recent prior systemic treatment for advanced/metastatic gastric cancer or GEJ cancer; Cohort C; Confirmed myeloid or lymphoid neoplasms as defined by WHO criteria with a FGFR1 rearrangement; 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: Prior treatment with an FGFR inhibitor; 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; Brain metastases that are untreated or clinically or radiologically unstable (that is, have been stable for <1 month).