FOENIX-CCA3 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Treatment<br/>TrialTypeTreatment
Trial

ThreePhase Three

18+Age Over 18

Stomach<br/>CancersCancer LocationStomach
Cancers

Treatment | Stomach and upper gastrointestinal tractBile duct

Trial Overview Read MoreRead more

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 MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

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

Commercial Sponsor

Taiho Oncology, Inc

Summary

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 MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

Next