Description:
The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a
monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma
harboring FGF/FGFR alterations.
Title
- Brief Title: A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)
- Official Title: A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations - (FIGHT-201)
Clinical Trial IDs
- ORG STUDY ID:
INCB 54828-201
- NCT ID:
NCT02872714
Conditions
Interventions
Drug | Synonyms | Arms |
---|
pemigatinib | INCB054828 | Cohort A-ID (Intermittent Dose) Pemigatinib |
pemigatinib | INCB054828 | Cohort A-CD (Continuous Dose) Pemigatinib |
Purpose
The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a
monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma
harboring FGF/FGFR alterations.
Trial Arms
Name | Type | Description | Interventions |
---|
Cohort A-ID (Intermittent Dose) Pemigatinib | Experimental | Pemigatinib in subjects with FGFR3 mutations or fusions. | |
Cohort A-CD (Continuous Dose) Pemigatinib | Experimental | Pemigatinib in subjects with FGFR3 mutations or fusions. | |
Cohort B Pemigatinib | Experimental | Pemigatinib in subjects with other FGF/FGFR alterations. | |
Eligibility Criteria
Inclusion Criteria:
- 20 years and older in Japan
- Histologically documented metastatic or surgically unresectable urothelial carcinoma;
may include primary site from urethra, ureters, upper tract, renal pelvis, and
bladder.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Life expectancy ≥ 12 weeks.
- Radiographically measurable per RECIST v1.1.
- Documented FGF/FGFR alteration and have either 1a) failed at least 1 previous
treatment for their metastatic or surgically unresectable urothelial carcinoma (ie,
chemotherapy, immunotherapy) or 1b) have not received chemotherapy due to poor ECOG
status or 2) have insufficient renal function.
Exclusion Criteria:
- Prior receipt of a selective FGFR inhibitor.
- Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives
(whichever is shorter) before the first dose of study drug.
- Inability or unwillingness to swallow pemigatinib or significant gastrointestinal
disorder(s) that could interfere with the absorption, metabolism, or excretion of
pemigatinib.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective response rate (ORR) in subjects with FGFR3 mutations based on RECIST v1.1 |
Time Frame: | Every 9 weeks throughout the study, up to approximately 6 months |
Safety Issue: | |
Description: | Defined as the proportion of subjects with best response (complete response or partial response) by RECIST v1.1. |
Secondary Outcome Measures
Measure: | Safety and tolerability of pemigatinib as assessed by the frequency, duration, and severity of adverse events |
Time Frame: | From screening through 30-35 days after end of treatment, up to approximately 6 months |
Safety Issue: | |
Description: | |
Measure: | Overall response rate (ORR) measuring the efficacy of pemigatinib in subjects with advanced/metastatic or surgically unresectable urothelial cancer with different molecular subgroups |
Time Frame: | From screening through 30-35 days after end of treatment, up to approximately 6 months |
Safety Issue: | |
Description: | |
Measure: | Progression-free survival (PFS) based on RECIST v1.1 |
Time Frame: | Every 9 weeks throughout the study, up to approximately 6 months |
Safety Issue: | |
Description: | Defined as number of days from the first day of taking study drug dose to the earlier of death or disease progression by RECIST v1.1 as assessed by the central radiographic review committee |
Measure: | Duration of response |
Time Frame: | Every 9 weeks throughout the study, up to approximately 6 months |
Safety Issue: | |
Description: | Defined as the number of days from the date of the first confirmed response to the date of the first documented evidence of disease progression or death. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Incyte Corporation |
Trial Keywords
- Urothelial carcinoma
- fibroblast growth factor (FGF)
- fibroblast growth factor receptor (FGFR)
- FGF/FGFR alterations
Last Updated
July 2, 2021