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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Open-Label, Single-Arm, Multicenter Study 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 (FIGHT-208)

Conditions
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Advanced or Metastatic Solid Tumors, FGFR Mutations, FGFR Translocations

Intervention / Treatment
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* Drug: Pemigatinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Participants will be assigned to 1 of 2 cohorts (Cohort A: FGFR1-3 in-frame fusions or FGFR2 intron 17 rearrangements; Cohort B: Known/predicted activating point mutations in FGFR1-3 [excluding kinase domain]) but there is no difference in the treatment regimen between the cohorts.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pemigatinib<br> | Drug: Pemigatinib<br>* Pemigatinib administered orally once daily.<br>* Other names: INCB054828;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Up to approximately 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) | 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. | Up to approximately 6 months | 
| Duration of Response (DOR) | 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. | Up to approximately 6 months | 
| Disease Control Rate (DCR) | Defined as the proportion of participants who achieved best overall response of CR, PR, or stable disease per RECIST v1.1 or RANO. | Up to approximately 6 months | 
| Overall Survival (OS) | Defined as the time from first dose of study drug to death of any cause in each cohort. | Up to approximately 6 months | 
| Number of Treatment-related Adverse Events | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment. | Up to approximately 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced solid tumor, metastatic solid tumor, FGFR inhibitor, FGFR mutation, FGFR translocation