Metastatic Prostate Cancer Clinical Trial
Official title:
Combined Targeting of the Androgen Receptor in Metastatic Castrate-Resistant Prostate Cancer With Enzalutamide and the Poly (ADP- Ribose) Polymerase (PARP) Inhibitor Niraparib: Hoosier Cancer Research Network GU14-202
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).
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
;
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