Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated 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: 1. Dose escalation portion to determine the MTD and/ or RP2D of futibatinib. 2. 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. 3. 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

  1. Provide written informed consent
  2. Age ≥ 18 years of age
  3. Has histologically or cytologically confirmed, locally advanced or metastatic cancer
  4. 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...

  1. History and/or current evidence of clinically significant non-tumor related alteration of calcium-phosphorus homeostasis.
  2. History and/or current evidence of clinically significant ectopic mineralization/calcification.
  3. History and/or current evidence of clinically significant retinal disorder
  4. A serious illness or medical condition(s)
  5. 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
At least 386 people participating
Last Updated