Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations 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.
Objective Response Rate (ORR) in Participants With FGFR2 Rearrangements or Fusions
ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Study Arms / Comparison Groups
Cohort A Pemigatinib
Description: Pemigatinib in subjects with FGFR2 translocation with a documented fusion partner in central laboratory report
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
January 16, 2017
February 1, 2022
Primary Completion Date
February 1, 2022
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.
18 Years - N/A
Accepts Healthy Volunteers
Luis Féliz Vinas, MD, ,
Luis Féliz Vinas, MD, Study Director, Incyte Corporation