Clinical Trials /

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

NCT04003623

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)
  • Official Title: 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)

Clinical Trial IDs

  • ORG STUDY ID: INCB 54828-MA-TA-208
  • NCT ID: NCT04003623

Conditions

  • Advanced or Metastatic Solid Tumors
  • FGFR Mutations
  • FGFR Translocations

Interventions

DrugSynonymsArms
PemigatinibINCB054828Pemigatinib

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
PemigatinibExperimental
  • Pemigatinib

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:Up to approximately 6 months
Safety Issue:
Description: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

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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Advanced solid tumor
  • metastatic solid tumor
  • FGFR inhibitor
  • FGFR mutation
  • FGFR translocation

Last Updated

January 9, 2020