RecruitingPhase 2NCT05727176
Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement
Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusions or Rearrangements
Sponsor
Taiho Oncology, Inc.
Enrollment
120 participants
Start Date
Jul 5, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
This is an open-label, multinational, randomized Phase 2 study confirming the clinical benefit of 20 mg futibatinib and evaluating the safety and efficacy of 16 mg futibatinib in previously treated CCA harboring FGFR2 gene fusions and other rearrangements.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- Histologically or cytologically confirmed, locally advanced, metastatic, or unresectable intrahepatic of extrahepatic Cholangiocarcinoma.
- Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangement
- Received at least one prior systemic gemcitabine and platinum-based regimen for CCA
- Documentation of radiographic disease progression on the most recent prior therapy
- Measurable disease
- performance status 0 or 1
- Adequate organ function
Exclusion Criteria17
- History or current evidence of calcium and phosphate homeostasis disorder
- Current evidence of clinically significant retinal disorder
- Treatment with any of the following within the specified time frame prior to the first dose of futibatinib:
- Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of futibatinib) and radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks
- Patients with locoregional therapy, eg, transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks
- Any non investigational anticancer therapy within 3 weeks or have not recovered from side effects of such therapy prior to futibatinib. Endocrine therapy is allowed for patients with breast or prostate cancer
- Targeted therapy or immunotherapy within 3 weeks or within 5 half lives Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever is shorter.
- Patients with prior FGFR-directed therapy
- A serious illness or medical condition(s) including (but not limited to) the following:
- Known brain metastasis (not including primary brain tumors) unless patient is clinically stable for ≥1 month
- Known acute systemic infection
- Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (New York Heart Association \[NYHA\] Class III or IV New York Heart Association \[NYHA\] Classification) within the previous 2 months; if \>2 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms
- Significant gastrointestinal disorder(s) that could interfere with the absorption of futibatinib.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the Investigator would make the patient inappropriate for entry into this study.
- Known additional malignancy that is progressing or requires active treatment, with the exception of patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or antitumor assessment of the investigational regimen. Exceptions must be discussed with the Sponsor prior to patient enrollment.
- Pregnant or lactating female.
- Known hypersensitivity or severe reaction to futibatinib or its excipients.
Interventions
DRUGTAS-120
TAS-120 is an oral FGFR inhibitor
Locations(65)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05727176
Related Trials
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
NCT059698602 locations
AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease
NCT057914482 locations
Phase I/II Trial of Pemigatinib in Combination With Atezolizumab and Bevacizumab for Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion
NCT064394851 location
Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
NCT058233111 location
Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients with Advanced Cholangiocarcinoma
NCT055320591 location