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.
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
Drug | Synonyms | Arms |
---|
Pemigatinib | INCB054828 | Pemigatinib |
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
Name | Type | Description | Interventions |
---|
Pemigatinib | Experimental | | |
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: | Active, not recruiting |
Lead Sponsor: | Incyte Corporation |
Trial Keywords
- Advanced solid tumor
- metastatic solid tumor
- FGFR inhibitor
- FGFR mutation
- FGFR translocation
Last Updated
July 16, 2021