Investigators aim 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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 240 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date: August 2016
Estimated Primary Completion Date: December 2019
Estimated Study Completion Date: January 2020
Primary Outcome Measures :
- 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 ]
Defined as the proportion of subjects with best response (complete response or partial response) by RECIST v1.1.
Secondary Outcome Measures :
- 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 ]
- 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 ]
- Progression-free survival (PFS) based on RECIST v1.1 [ Time Frame: Every 9 weeks throughout the study, up to approximately 6 months ]
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
- Duration of response [ Time Frame: Every 9 weeks throughout the study, up to approximately 6 months ]
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.
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
- 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.
- 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.