Spots Global Cancer Trial Database for Enzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC)

Study Description

Brief Summary: This is a phase I study to determine the safety and feasibility of the combination of enzalutamide and niraparib in subjects with metastatic castration-resistant prostate cancer (CRPC).

Detailed Description: 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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Contact Details

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