Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)

• Status: Active, not recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumors harboring activating FGFR mutations or translocations.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic (Stage IIIB or IV) or is surgically unresectable.

• Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors).

• Documentation of an FGFR1-3 gene mutation or translocation.

• Objective disease progression after at least 1 prior therapy.

• Not eligible or able to participate in any other Incyte-sponsored clinical trial.

Exclusion Criteria:

• Advanced/metastatic bladder cancer or advanced/metastatic cholangiocarcinoma.

• Prior receipt of a selective FGFR inhibitor.

• Current evidence of clinically significant corneal or retinal disorder.

• History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.