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

Phase 2TerminatedNCT04003623

Incyte Corporation1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced or Metastatic Solid Tumors FGFR Mutations FGFR Translocations

Interventions

PemigatinibDRUG

Pemigatinib administered orally once daily.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

Compassionate Cancer Care Medical Group

Fountain Valley, California, United States

Ocala Oncology Center

Ocala, Florida, United States

Hawaii Cancer Care

Honolulu, Hawaii, United States

Outcomes

Primary Outcomes

Objective Response Rate (ORR)

Defined as the proportion of participants in each cohort who achieve a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)