Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

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.

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