NCT01732107

Dovitinib in BCG Refractory Urothelial Carcinoma With FGFR3 Mutations or Over-expression

A Phase II Trial of Dovitinib in Bacillus Calmette-Guerin(BCG) Refractory Urothelial Carcinoma Patients With Tumor Fibroblast Growth Factor Receptor 3(FGFR3) Mutations or Over-expression: Hoosier Cancer Research Network GU12-157

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Noah Hahn, M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will assess the 6-month complete response rate and toxicity profile of oral dovitinib therapy in BCG-refractory urothelial carcinoma patients with tumors with FGFR3 mutations or over-expression who are ineligible for or refusing cystectomy.

Detailed description

OUTLINE: This is a multi-center study. * Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2. * Standard of Care: Cystoscopy with tumor biopsy, bladder biopsy, urine cytology * Physician discretion: Anti-emetic medications and/or colony stimulating growth factors ECOG performance status 0 - 2 Hematopoietic: * White blood cell count (WBC) \> 3.0 K/mm3 * Absolute neutrophil count (ANC) ≥ 1.5 K/mm3 * Platelets ≥ 100 K/mm3 * Hemoglobin (Hgb) ≥ 9 g/dL Hepatic: * Serum total bilirubin: ≤ 1.5 x Upper limit of normal (ULN) * Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 3.0 x ULN Renal: * Serum creatinine ≤ 1.5 x ULN or serum creatinine \> 1.5 - 3 x ULN if calculated creatinine clearance (CrCl) is ≥ 30 mL/min using the Cockcroft-Gault equation Cardiovascular: No impaired cardiac function or clinically significant cardiac diseases, including any of the following: * History or presence of serious uncontrolled ventricular arrhythmias * Clinically significant resting bradycardia * LVEF assessed by 2-D echocardiogram (ECHO) \< 50% or lower limit of normal (whichever is higher) or multiple gated acquisition scan (MUGA), \< 45% or lower limit of normal (whichever is higher) * Myocardial Infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE)within 6 months prior to starting study drug

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Dovitinib	Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.

Timeline

• Start date: 2013-03-01
• Primary completion: 2017-03-06
• Completion: 2017-03-06
• First posted: 2012-11-22
• Last updated: 2022-07-11
• Results posted: 2018-08-22

Locations

3 sites across 1 country: United States