Cholangiocarcinoma (CCA) affects approximately 8,000 to 10,000 individuals a year in the United States.11,12 FGFR genetic alterations are present in 25% of CCA cases.3 These include mutations, amplifications/deletions, and rearrangements/translocations, which sometimes result in fusion genes.13,14
In early clinical trials, infigratinib* has shown clinical activity in CCA with FGFR2 fusions.7 A single-arm, open-label, Phase 2 trial for infigratinib is being conducted in patients with advanced or metastatic CCA with FGFR2 gene fusions/translocations, or other FGFR genetic alterations who also:
- Show evidence of radiologic progression following a gemcitabine + cisplatin regimen for advanced disease
- Have been treated with a gemcitabine-containing regimen, but cannot tolerate cisplatin
This trial remains open and is enrolling patients previously treated with an FGFR inhibitor, and patients with alterations other than FGFR2 fusions.
Amended Cohorts of the Second-line Trial
- Cohort 1: patients with FGFR2 gene fusions or translocations
- Cohort 2: patients with FGFR genetic alterations other than FGFR2 gene fusions or translocations
- Cohort 3: patients with FGFR2 gene fusions or translocations who have received a prior FGFR inhibitor
- All patients will receive oral infigratinib, once daily, on a schedule of 3 weeks on (21 days), 1 week off (7 days). One treatment cycle consists of 28 days.
Learn more about Phase 2, Second-line Clinical Trial for Cholangiocarcinoma, which is currently enrolling