A Phase 2, Open-Label, Single-Agent, Multicenter Study to investigate the Efficacy and Safety of INCB054828 in Subjects Advanced Bladder cancer with FGF/FGFR Alterations (FIGHT-201)
- Conditions
- Subjects with metastatic or surgically unresectable urothelial cancer (may include primary site from ureters, upper tract, renal pelvis, and bladder) with an FGF/FGFR alteration, who failed at least 1 previous treatment or are platinum ineligible.MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-001321-14-NL
- Lead Sponsor
- Incyte Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
• Men and women, aged 18 or older. For subjects in Japan, if the subject is below the age of 20 years, voluntary agreement shall be obtained from the subject and the representative or legal guardian using the written consent form.
• 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, 1, or 2.
• Life expectancy = 12 weeks.
• Radiographically measurable disease per RECIST v1.1.
• Documented FGF/FGFR alteration and have either:
- have failed at least 1 previous treatment for their metastatic or surgically unresectable urothelial carcinoma (ie, chemotherapy, immunotherapy), or
- have not received chemotherapy for metastatic or surgically unresectable urothelial carcinoma due to poor performance status (ie, ECOG performance status of 2) and insufficient renal function (ie, creatinine clearance < 60 mL/min or local guidelines).
• Willingness to avoid pregnancy or fathering children. For subjects in Japan, female subjects who have been amenorrhoeic for at least 12 months resulting from chemotherapy/radiotherapy are considered of childbearing potential and should agree to use adequate contraceptive measures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 70
• Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 28 days before first dose of study drug. Subjects must have recovered (Grade = 1 or at pretreatment baseline) from AEs from previously administered therapies.
• Prior receipt of a selective FGFR inhibitor.
• Abnormal laboratory parameters:
- Total bilirubin = 1.5 × upper limit of normal (ULN; = 2.5 × ULN if Gilbert syndrome or metastatic disease involving liver).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 × ULN (AST and ALT > 5 × ULN in the presence of liver metastases).
- Creatinine clearance = 30 mL/min based on Cockroft-Gault.
- Serum phosphate > institutional ULN.
- Serum calcium outside of the institutional normal range or serum albumin-corrected calcium outside of the institutional normal range when serum albumin is outside of the institutional normal range.
• 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.
• Known hypersensitivity or severe reaction to INCB054828 or excipients of INCB054828 study drug.
• Inability or unwillingness to swallow INCB054828 or significant gastrointestinal disorder(s) that could interfere with the absorption, metabolism, or excretion of INCB054828.
• Subjects who require hemodialysis.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method