Clinical trial · Interventional
Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was closed due to lack of enrollment.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced or Metastatic Solid Tumors | — | UNRESOLVED | — |
| FGFR Mutations | — | UNRESOLVED | — |
| FGFR Translocations | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pemigatinib | Drug | Pemigatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pemigatinib
- interventionNames
- Drug: Pemigatinib
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Up to approximately 6 months
- 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 outcomes (5)
- measure
- Progression-free Survival (PFS)
- timeFrame
- Up to approximately 6 months
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available