Finding studies
Finding studies
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Lead
Paul Mathew, MD
With
OUTLINE: This is a multi-center trial. INVESTIGATIONAL TREATMENT: Each eligible subject will begin treatment with a 28-day enzalutamide 160 mg/day lead-in cycle. If a subject is able to tolerate the lead-in enzalutamide cycle without Grade 2 or Grade 2-4 drug-related toxicity, dose reduction, or missed doses due to toxicity, cycle 1 of combined enzalutamide and niraparib will commence. Enzalutamide will continue at 160 mg daily. Niraparib will be dosed daily starting at 100mg (dose level 1). Six subjects will be enrolled per dose level. If less than 33% of the subjects experience a dose-limiting toxicity (DLT) at the beginning of cycle 2, then the daily dose of niraparib will escalate to 200mg (dose level 2). If dose level 2 is similarly tolerated, then the daily dose of niraparib escalate to 300mg (dose level 3). The following required laboratory values must be obtained within 14 days prior to registration for protocol therapy: Hematopoietic: * White blood cell count (WBC) ≥ 1500/mm3 * Hemoglobin (Hgb) ≥ 9 g/dL * Platelets ≥ 150,000/µL * Absolute neutrophil count (ANC) ≥ 1500/mm3 Renal: * Calculated creatinine clearance of ≥ 40 cc/min using the Cockcroft-Gault formula Hepatic: * Bilirubin ≤ 1.5 × upper limit of normal (ULN) * Aspartate aminotransferase (AST, SGOT) ≤ 2.5 × ULN
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted