INCB 54828-201 A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations (FIGHT-201)
- Conditions
- bladder cancerurothelial carcinoma10038364
- Registration Number
- NL-OMON49349
- Lead Sponsor
- Incyte Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 7
* 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.
* 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Objective response rate in subjects with FGFR3 mutations or fusions based on<br /><br>central genomics laboratory results and INCB054828<br /><br>administered using a continuous dose regimen (Cohort A-CD). Response will be<br /><br>based on review of scans by a centralized radiological review committee.</p><br>
- Secondary Outcome Measures
Name Time Method