A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)

Incyte

Status and phase: Completed; Phase 2

Conditions: UC (Urothelial Cancer)

Treatments: Drug: pemigatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02872714

INCB 54828-201

Details and patient eligibility

About

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.

Enrollment: 263 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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263 participants in 3 patient groups

Cohort A-ID (Intermittent Dose) Pemigatinib

Experimental group

Description:

Pemigatinib in subjects with FGFR3 mutations or fusions.

Treatment:

Drug: pemigatinib

Drug: pemigatinib

Cohort A-CD (Continuous Dose) Pemigatinib

Experimental group

Description:

Pemigatinib in subjects with FGFR3 mutations or fusions.

Treatment:

Drug: pemigatinib

Drug: pemigatinib

Cohort B Pemigatinib

Experimental group

Description:

Pemigatinib in subjects with other FGF/FGFR alterations.

Treatment:

Drug: pemigatinib

Drug: pemigatinib