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

Incyte

Status and phase: Terminated; Phase 2

Conditions: FGFR Translocations; FGFR Mutations; Advanced or Metastatic Solid Tumors

Treatments: Drug: Pemigatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04003623

INCB 54828-MA-TA-208

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Pemigatinib

Experimental group

Treatment:

Drug: Pemigatinib