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

Brief Title

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

Official Title

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)

Brief Summary

      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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Objective Response Rate (ORR) in Participants With FGFR2 Rearrangements or Fusions

Secondary Outcome

 ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions

Condition

Cholangiocarcinoma

Intervention

Pemigatinib

Study Arms / Comparison Groups

 Cohort A Pemigatinib

Description:  Pemigatinib in subjects with FGFR2 translocation with a documented fusion partner in central laboratory report

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

147

Start Date

January 16, 2017

Completion Date

February 1, 2022

Primary Completion Date

February 1, 2022

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Luis Féliz Vinas, MD, , 

Location Countries

Belgium

Location Countries

Belgium

NCT ID

NCT02924376

Organization ID

INCB 54828-202

Responsible Party

Sponsor

Study Sponsor

Incyte Corporation

Study Sponsor

Luis Féliz Vinas, MD, Study Director, Incyte Corporation

Verification Date

January 2023