drugset / Trial / NCT03656536
A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is 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.
Timeline
- Start
- 2019-06-03
- Primary completion
- 2025-07-07
- Completion
- 2025-07-07
Outcome
Met primary endpoint
Stopped (Enrollment): “The study was terminated due to lack of enrollment resulting from a change in the standard of care for the first-line treatment of patients with cholangiocarcinoma. There were no safety concerns that contributed to this decision.”
paper 8.3 months in the pemigatinib group versus 6.8 months in the chemotherapy group (hazard ratio, 0.58 [95% CI, 0.39 to 0.87]; nominal P = .0078) PMID 42223137 ↗
Publications
- Bekaii-Saab TS, Melisi D, Wilmink H, Garufi C, Tran N, Tortora G, De Braud F, Frodin JE, Lonardi S, Lin E, Babiker H, Lin B, Fornaro L, Munoz Martin A, Bridgewater J, Knox JJ, De Vos-Geelen J, Scott-Brown M, Veronese L, Ioannidis S, Gilmartin A, Janik JE, Guo Y, Furuse J, Ioka T, Rimassa L, Vogel A. Pemigatinib for Unresectable or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor-2 Rearrangement: Results From the Phase III FIGHT-302 Trial. J Clin Oncol. 2026 Jun 1:JCO2600788. doi: 10.1200/JCO-26-00788. Online ahead of print.
- Bekaii-Saab TS, Valle JW, Van Cutsem E, Rimassa L, Furuse J, Ioka T, Melisi D, Macarulla T, Bridgewater J, Wasan H, Borad MJ, Abou-Alfa GK, Jiang P, Lihou CF, Zhen H, Asatiani E, Feliz L, Vogel A. FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements. Future Oncol. 2020 Oct;16(30):2385-2399. doi: 10.2217/fon-2020-0429. Epub 2020 Jul 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Pemigatinib | Small molecule | 13.5 mg | Oral |