Efficacy and Safety of Pemigatinib in Subjects With Advanced / Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202)
Trial Status: Complete
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.
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: CLOSED_TO_ACCRUAL
Tucson
Banner University Medical Center - Tucson
Status: CLOSED_TO_ACCRUAL
Contact: Gloria E Rippe
Phone: 520-694-9049
Email:
GRippe@uacc.arizona.edu
California
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Colorado
Aurora
University of Colorado Hospital
Status: COMPLETED
Connecticut
New Haven
Yale University
Status: CLOSED_TO_ACCRUAL
Contact: Kamil Sadowski
Phone: 203-785-6661
Email:
kamil.sadowski@yale.edu
District of Columbia
Washington
MedStar Georgetown University Hospital
Status: ACTIVE
Florida
Jacksonville
Mayo Clinic in Florida
Status: CLOSED_TO_ACCRUAL
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Kansas
Fairway
University of Kansas Clinical Research Center
Status: CLOSED_TO_ACCRUAL
Kansas City
University of Kansas Cancer Center
Status: CLOSED_TO_ACCRUAL
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: CLOSED_TO_ACCRUAL
Maryland
Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE
Michigan
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Detroit
Wayne State University / Karmanos Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: COMPLETED
New York
New York
Icahn School of Medicine at Mount Sinai
Status: ADMINISTRATIVELY_COMPLETE
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: COMPLETED
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: COMPLETED
Oregon
Portland
OHSU Knight Cancer Institute
Status: CLOSED_TO_ACCRUAL
Pennsylvania
Philadelphia
Fox Chase Cancer Center
Status: CLOSED_TO_ACCRUAL
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE
Texas
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
Contact: Marcella West Aguilar
Phone: 214-648-1479
Utah
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: COMPLETED
Wisconsin
Madison
University of Wisconsin Carbone Cancer Center
Status: COMPLETED
Trial Phase Phase II
Trial Type Treatment
Lead Organization
Incyte Corporation
- Primary ID INCB 54828-202
- Secondary IDs NCI-2017-00027, s16-02031
- Clinicaltrials.gov ID NCT02924376