Clinical Trials Logo
  1. Home
  2. Advanced Cholangiocarcinoma
  3. NCT03773302

Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations

Advanced Cholangiocarcinoma Clinical Trial

Official title:
A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial

Clinical Trial Summary

Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement. Subjects will be randomized 2:1 to receive infigratinib or gemcitabine plus cisplatin.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03773302
Study type Interventional
Source QED Therapeutics, Inc.
Contact
Status Terminated
Phase Phase 3
Start date December 27, 2019
Completion date March 1, 2023
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 NCT05727176 - Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement Phase 2
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
Terminated 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
Approved for marketing NCT04507503 - Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements