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

Phase 2

Terminated

Conditions: Advanced or Metastatic Solid Tumors
FGFR Translocations
FGFR Mutations

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Pemigatinib	Pemigatinib	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Up to approximately 6 months	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)

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR)	Up to approximately 6 months	Defined as the proportion of participants who achieved best overall response of CR, PR, or stable disease per RECIST v1.1 or RANO.
Duration of Response (DOR)	Up to approximately 6 months	Defined as the time from the date of first assessment of CR or PR until the date of the first progressive disease (per RECIST v1.1 or RANO) or death (whichever is first) in each cohort.
Progression-free Survival (PFS)	Up to approximately 6 months	Defined as the time from first dose until progressive disease (per RECIST v1.1 or Response Assessment in Neuro-Oncology \[RANO\]) or death (whichever is first) in each cohort.
Overall Survival (OS)	Up to approximately 6 months	Defined as the time from first dose of study drug to death of any cause in each cohort.
Number of Treatment-related Adverse Events	Up to approximately 6 months	Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

Locations (11): Hawaii Cancer Care
🇺🇸
Honolulu, Hawaii, United States
FMH James M Stockman Cancer Institute
🇺🇸
Frederick, Maryland, United States
Ocala Oncology Center
🇺🇸
Ocala, Florida, United States
New Jersey Cancer Care and Blood Disorders
🇺🇸
Belleville, New Jersey, United States
Utah Cancer Specialists
🇺🇸
Salt Lake City, Utah, United States
Sanford Cancer Center
🇺🇸
Sioux Falls, South Dakota, United States
Compassionate Cancer Care Medical Group
🇺🇸
Fountain Valley, California, United States
Illinois Cancer Care
🇺🇸
Peoria, Illinois, United States
TriHealth
🇺🇸
Cincinnati, Ohio, United States
Mary Crowley Cancer Center
🇺🇸
Dallas, Texas, United States
Oncology Consultants
🇺🇸
Houston, Texas, United States