FOENIX-CCA3
Research type
Research Study
Full 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
IRAS ID
282826
Contact name
John Bridgewater
Contact email
Sponsor organisation
Taiho Oncology Inc
Eudract number
2019-004630-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 1 months, 0 days
Research summary
Cholangiocarcinoma (CCA), also known as bile duct cancer, is a rare tumour that forms in the bile ducts. Unfortunately, symptoms of CCA are usually not apparent until the disease has reached an advanced stage and therefore most patients have disease which is unresectable at diagnosis. The prognosis of patients with advanced stage III and IV CCA is extremely poor, with 5-year survival rates of 10% and 0% respectively. Although there are no approved treatments in this setting, gemcitabine/cisplatin is the current standard first-line chemotherapy regimen for patients with advanced, metastatic, unresectable CCA.
In certain types of cancers, rearrangements in the FGFR gene has been identified as an early driver of oncogenic events. Futibatinib is a selective small molecule FGFR inhibitor, which has shown promising antitumor activity in both preclinical and ongoing clinical studies, against a variety of tumour types harbouring FGFR aberrations.In this phase 3 study, the safety and efficacy of the futibatinib will be evaluated against SoC treatment of patients with advanced, metastatic, or recurrent inoperable intrahepatic CCA, harbouring FGFR2 gene rearrangements.
Patients will be pre-screened in the first instance to assess their FGFR2 gene rearrangement status. If deemed eligible, they will be randomised on a 1:1 basis to the Experimental Arm, or the Control (SoC) Arm.In the Experimental Arm, patients may receive futibatinib at a daily oral dose of 20 mg, whilst patients in the Control Arm patients may receive gemcitabine-cisplatin chemotherapy on days 1 and 8 of a 21-day cycle. Patients who discontinue gemcitabine-cisplatin for reasons such as documented disease progressing, or other withdrawal criteria, will be able to cross over to the Experimental Arm and receive futibatinib instead, if deemed medically appropriate and inclusion criteria are met.
This study is aiming to enroll 216 participants globally.
REC name
London - Brent Research Ethics Committee
REC reference
21/LO/0239
Date of REC Opinion
6 May 2021
REC opinion
Further Information Favourable Opinion