INCB54828-302 Pemigatinib versus Chemotherapy in Cholangiocarcinoma
Research type
Research Study
Full title
A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)
IRAS ID
255226
Contact name
Harpreet Wasan
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2018-002894-23
Clinicaltrials.gov Identifier
138,179, IND Number
Duration of Study in the UK
4 years, 2 months, 4 days
Research summary
This is an open-label, randomised study of pemigatinib versus gemcitabine plus cisplatin chemotherapy as first-line treatment in participants with unresectable and/or metastatic cholangiocarcinoma with FGFR2 rearrangement.
The study drug pemigatinib is an inhibitor of the fibroblast growth factor receptor (FGFR) family of receptor tyrosine kinases. Fibroblast growth factor receptor signalling contributes to the developing of malignancies by promoting tumour cell proliferation (rapid growth), survival, migration, and angiogenesis (development of new blood vessels).
Participants will sign a pre-screening informed consent form and a tumour biopsy will be evaluated by a central laboratory to document FGFR2 rearrangement.
Following documentation of the participant's FGFR2 rearrangement, the participants will then undergo screening and if they meet the rest of the inclusion/exclusion criteria, they will be enrolled into the study into one of the following two groups by randomisation (means that they will receive either the Study Drug or chemotherapy by chance):
• Treatment Group A: Pemigatinib (13.5 mg) taken by mouth, once a day, every day for each 3-week cycle.
• Treatment Group B: Gemcitabine (1000 mg/m2) plus cisplatin (25 mg/m2) administered as intravenous infusion (through a vein) on Days 1 and 8 of every 3-weeks cycle for up to 8 cycles.Treatment will start on Day 1. Participants will undergo regular safety assessments during treatment as well as regular efficacy assessments.
Participants in the treatment group A (Pemigatinib) will be allowed to continue administration in 21-day cycles as long as they are receiving benefit and have not met any criteria for study withdrawal.
Participants in the treatment group B (Chemotherapy: Gemcitabine plus Cisplatin)who progress under this treatment, will be eligible to receive second-line treatment with pemigatinib under the cross over part of this study.The study will enrol approximately 432 participants in total. This study is sponsored by Incyte Corporation.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
19/NW/0155
Date of REC Opinion
30 May 2019
REC opinion
Further Information Favourable Opinion