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

• Status: Completed
• Trial end date: 2021-09-29
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

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.