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
- 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: 19.0Level: 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-ES
- Lead Sponsor
- Incyte Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 260
• Men and women, aged 18 or older.
• Histologically documented metastatic or surgically unresectable urothelial carcinoma; may include primary site from 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 or evaluable disease per RECIST v1.1.
• Known FGF/FGFR alteration from the sponsor's central laboratory 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.
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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
• Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives (whichever is longer) 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