This phase III trial is trying to understand how safe and effective a targeted therapy drug (futibatinib)is compared to chemotherapy (gemcitabine-cisplatin) as first-line treatment in people with advanced, metastatic or recurrent cholangiocarcinoma with FGFR2 gene rearrangements.
This trial is treating patients with advanced cholangiocarcinoma with FGFR2 gene rearrangements.
This is a systemic therapy trial.
You may be able to join this trial if:
- You are able to swallow medication by mouth.
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had treatment, but your cancer has come back.
- Your cancer has not spread to other parts of the body.
- Your cancer has spread to other parts of the body.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Use the hyperlinks, where available to access additional clinical trial information.
A Phase 3, Open-Label, Randomized Study of Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements FOENIX-CCA3
Taiho Oncology, Inc
This is a randomised trial with experimental and active comparator arms. Participants in the Experimental arm will receive TAS-120 (Futibatinib) which is an FGFR inhibitor, orally on a 21-day cycle. Participants in the Active Comparator Arm will receive Cisplatin/Gemcitabine whicih is currently 1st line standard of care. Cisplatin 25 mg/m2 in 1000 mL 0.9% saline will be administered intravenously over 1 hour, followed by 500 mL 0.9% saline over 30 minutes; and Gemcitabine 1000 mg/m2 in 250-500 mL 0.9% saline will be administered intravenously over 30 minutes, beginning after completion of the cisplatin and saline infusions.
Recruiting Hospitals Read More