A Study of TAS-120 in Patients With Advanced Solid Tumors
a study on Cholangiocarcinoma Transitional Cell Carcinoma Metastatic Cancer Patients With Tumors Harboring FGF/FGFR Tumors Central Nervous System Tumor Breast Cancer Stomach Cancer Solid Tumor Neoplasms
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCSF
- Dates
- study startedestimated completion
Description
Summary
This is an open-label, nonrandomized, Phase 1/2 study for the fibroblast growth factor receptor (FGFR) inhibitor futibatinib (TAS-120). The purpose of the study is to evaluate the safety, tolerability, PK, pharmacodynamic, and anti-tumor activity of futibatinib in patients with advanced solid tumors with and without genomic FGF/FGFR abnormalities. The study will be conducted in 3 parts:
- Dose escalation portion to determine the MTD and/ or RP2D of futibatinib.
- Phase 1 expansion portion to further evaluate the safety and efficacy of futibatinib in patients with tumors harboring FGF/FGFR aberrations, including patients with cholangiocarcinoma (CCA), primary CNS tumors, urothelial carcinoma, breast cancer, gastric cancer.
- Phase 2 study portion to confirm ORR of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).
Official Title
Phase 1/2 Study of TAS-120 in Patients With Advanced Solid Tumors Harboring FGF/FGFR Aberrations
Keywords
Cholangiocarcinoma, Urothelial Cancer, Advanced and Metastatic Cancer Patients With Tumors Harboring FGF/FGFR Tumors, Primary CNS Tumors, Breast Cancer, Gastric Cancer, FGF, FGFR, Futibatinib, TAS-120, Neoplasms
Eligibility
You can join if…
Open to people ages 18 years and up
- Provide written informed consent
- Age ≥ 18 years of age
- Has histologically or cytologically confirmed, locally advanced or metastatic cancer
- The following specific criteria for each study portion
Phase 1 (Dose Escalation):
- Patients with any type of solid tumor - Disease progression following standard therapies or intolerant to prior standard therapies
Phase 1 (Dose Expansion)
- Have at least one FGF/FGFR aberration - Disease progression following standard therapies or were intolerant to prior standard therapies (including prior FGFR inhibitors). - Have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009) for advanced solid tumors or RANO criteria (2010) for brain tumors. - Patients with any of the following tumor types - Patients with intrahepatic or extrahepatic CCA harboring FGFR2 gene fusions or other FGFR2 aberrations - Patients with primary CNS tumors - Patients with advanced urothelial carcinoma with FGFR3 fusions or FGFR3 activating mutations - Patients with breast cancer or gastric cancer - Patients with other solid tumor types harboring FGFR gene fusions or activating mutations - Patients with solid tumor types and other FGF/FGFR alterations not listed above
Phase 2
- Patients with iCCA and FGFR2 gene rearrangements (incl fusions) - Have been treated with at least one prior systemic gemcitabine and platinum-based chemotherapy - Must have documentation of radiographic progression of disease - No prior FGFR inhibitor - Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ function.
You CAN'T join if...
- History and/or current evidence of clinically significant non-tumor related alteration of calcium-phosphorus homeostasis.
- History and/or current evidence of clinically significant ectopic mineralization/calcification.
- History and/or current evidence of clinically significant retinal disorder
- A serious illness or medical condition(s)
- Pregnant or breast-feeding female
Locations
- UCSF Helen Diller Family Comprehensive Cancer Center. Mission Bay
San Francisco California 94158 United States - City of Hope National Medical Center
Duarte California 91010 United States
Details
- Status
- in progress, not accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Taiho Oncology, Inc.
- ID
- NCT02052778
- Phase
- Phase 1/2 research study
- Study Type
- Interventional
- Participants
- About 386 people participating
- Last Updated