Futibatinib in Patients With Specific FGFR Aberrations
Stopped early · Phase 2
Conditions studied: Advanced or Metastatic Solid Tumor, Advanced or Metastatic Gastric or Gastroesophageal Cancer, Myeloid or Lymphoid Neoplasms (MLN)
In brief
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.
Key facts
- Study ID
- NCT04189445
- Run by
- Taiho Oncology, Inc.
- People needed
- 115
- Starts
- 2020-08-05
- Expected to finish
- 2024-11-11
- Last updated by the study team
- 2025-10-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- UCLA Medical Center — Los Angeles, California, United States
- Georgetown University - Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
- University of Maryland — Baltimore, Maryland, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Henry Ford Hospital — Woodhaven, Michigan, United States
- Mercy Clinic Oncology and Hematology - Coletta — Oklahoma City, Oklahoma, United States
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
- Houston Methodist Cancer Center — Houston, Texas, United States
- The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States
- Institut Jules Bordet — Brussels, Belgium
- Centre Antoine Lacassagne — Nice, Alpes Maritimes, France
- Centre Paul Strauss — Strasbourg, Bas Rhin, France
- Centre Georges François Leclerc — Dijon, Côte-d'Or, France
- Institut Bergonié — Bordeaux, Gironde, France
- Hôpital Saint-Louis — Paris, Paris, France
- Centre Léon Bérard — Lyon, Rhone, France
- Centre Hospitalier Lyon Sud — Pierre-Bénite, Rhone, France
- Institut Gustave Roussy — Villejuif, Val De Marne, France
- Universitaetsklinikum Freiburg — Freiburg im Breisgau, Baden-Wurttemberg, Germany
- Universitaetsklinikum Heidelberg — Heidelberg, Baden-Wurttemberg, Germany
- Universitaetsklinikum Koeln — Cologne, North Rhine-Westphalia, Germany
- The University of Hong Kong — Hong Kong, Hong Kong
- Hong Kong United Oncology Centre — Jordon, Hong Kong
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
Full record on ClinicalTrials.gov
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