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

Status: Active

Description

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.

Eligibility 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.

Locations & Contacts

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not Available

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: Active
Name Not Available

Florida

Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Name Not Available

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Incyte Corporation

Trial IDs

Primary ID INCB 54828-202
Secondary IDs NCI-2017-00027, s16-02031
Clinicaltrials.gov ID NCT02924376