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

  • Interventional
  • Not Recruiting
  • NCT02924376
Eligibility Details Visit Clinicaltrials.gov

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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.

At a Glance

National Government IDNCT02924376

IRB#IRB16-0873

Lead SponsorIncyte Corporation

Lead PhysicianDaniel Catenacci

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting