Efficacy and Safety of Pemigatinib in Subjects With Advanced / Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)

The purpose of this study is evaluate the efficacy of pemigatinib in subjects with advanced / metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation who have failed at least 1 previous treatment.

Inclusion Criteria

• Histologically or cytologically confirmed cholangiocarcinoma.
• Radiographically measurable or evaluable disease per RECIST v1.1.
• Tumor assessment for FGF/FGFR gene alteration status.
• Documented disease progression after at least 1 line of prior systemic therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• Life expectancy ≥ 12 weeks.

Exclusion Criteria

• Prior receipt of a selective FGFR inhibitor.
• History of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
• Current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.
• Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug. Topical ketoconazole will be allowed.

Lead Organization
Incyte Corporation