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 Oncology Group GU12-157
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
- 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
- Serum total bilirubin: ≤ 1.5 x Upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 3.0 x ULN
- 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
No impaired cardiac function or clinically significant cardiac diseases, including any of
- 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
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine 6-Month Complete Response Rate
The 6-month complete response rate is defined as the proportion of patients treated with dovitinib with no evidence of any remaining urothelial carcinoma tumors of any T-stage (including Tis) present within the bladder as assessed by standard of care cystoscopic examination with transurethral resection of bladder tumor (TURBT) and urine cytology performed at 6 months after initiation of study therapy.
Noah Hahn, M.D.
Hoosier Oncology Group
United States: Food and Drug Administration
|Indiana University Melvin and Bren Simon Cancer Center||Indianapolis, Indiana 46202-5289|