Efficacy and Safety of Pemigatinib in Subjects With Advanced / Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
Trial Status: Closed to Accrual
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.
- 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.
- 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.
Mayo Clinic in Arizona
Banner University Medical Center - Tucson
Contact: Gloria E Rippe
UC Irvine Health / Chao Family Comprehensive Cancer Center
University of Colorado Hospital
Contact: Kamil Sadowski
District of Columbia
MedStar Georgetown University Hospital
Mayo Clinic in Florida
University of Chicago Comprehensive Cancer Center
University of Kansas Clinical Research Center
University of Kansas Cancer Center
University of Kansas Hospital-Westwood Cancer Center
Johns Hopkins University / Sidney Kimmel Cancer Center
University of Michigan Comprehensive Cancer Center
Wayne State University / Karmanos Cancer Institute
Siteman Cancer Center at Washington University
Icahn School of Medicine at Mount Sinai
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Memorial Sloan Kettering Cancer Center
Case Comprehensive Cancer Center
OHSU Knight Cancer Institute
Fox Chase Cancer Center
University of Pittsburgh Cancer Institute (UPCI)
UT Southwestern / Simmons Cancer Center-Dallas
Contact: Marcella West Aguilar
Salt Lake City
Huntsman Cancer Institute / University of Utah
University of Wisconsin Hospital and Clinics
Trial Phase Phase II
Trial Type Treatment
- Primary ID INCB 54828-202
- Secondary IDs NCI-2017-00027, s16-02031
- Clinicaltrials.gov ID NCT02924376