Clinical Trials Logo
  1. Home
  2. Advanced Cholangiocarcinoma
  3. NCT05727176

Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement — FOENIX-CCA4  

Advanced Cholangiocarcinoma Clinical Trial

Official title:
Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusions or Rearrangements

Clinical Trial 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.

Clinical Trial Description

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. Eligible patients will be randomized on a 1:1 basis to the following study arms: - Patients will receive futibatinib at an oral dose of 16 mg, administered daily (QD) on every day of a 21-day cycle. - Patients will receive futibatinib at an oral dose of 20 mg, administered daily (QD) on every day of a 21-day cycle. Patients may continue to receive continuous futibatinib until documentation of progressive disease (PD) per RECIST 1.1, or until other withdrawal criteria are met, whichever comes first. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05727176
Study type Interventional
Source Taiho Oncology, Inc.
Contact Taiho Oncology, INC
Phone 609-250-7336
Email clinicaltrialinfo@taihooncology.com
Status Recruiting
Phase Phase 2
Start date May 12, 2023
Completion date June 2026
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05823311 - Lenvatinib, Tislelizumab Combined With Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma Phase 3
Recruiting NCT05791448 - AU409 for the Treatment of Advanced Primary Liver Cancers or Solid Tumor With Liver Metastatic Disease Phase 1
Active, not recruiting NCT04093362 - Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements Phase 3
Recruiting NCT03996408 - Study of TQB2450 Combined With Anlotinib in Subjects With Advanced Cholangiocarcinoma Phase 1/Phase 2
Terminated NCT02982720 - Evaluating Combination Immunotherapy for Advanced Cholangiocarcinoma With Pembrolizumab and PEG-Intron Phase 2
Terminated NCT02150967 - A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma Phase 2
Recruiting NCT03982680 - Toripalimab Combined With Gemcitabine/5--fluoropyrimidine for Advanced Cholangiocarcinoma Phase 2
Recruiting NCT05532059 - Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin (GPLET) in Patients With Advanced Cholangiocarcinoma Phase 2
Active, not recruiting NCT04088188 - Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma Phase 1
Completed NCT02989857 - Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy) Phase 3
Recruiting NCT05805956 - IMM2902 in Patients With Advanced Solid Tumors Expressing HER2 Phase 1/Phase 2
Terminated NCT03773302 - Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations Phase 3
Approved for marketing NCT04507503 - Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements