NCT02500901

Enzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC)

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Paul Mathew, MD · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Metastatic Prostate Cancer

Interventions

Type	Name	Description
DRUG	Enzalutamide	Following completion of 28-day lead-in cycle, enzalutamide 160 mg PO daily will continue to be administered in 28-day cycles until documented progression, unmanageable toxicity, or decision to discontinue for any reason.
DRUG	Niraparib	Niraparib will be administered daily in three dose-escalation cohorts of 6 subjects per dose levels of 100mg PO, 200mg PO or 300mg PO in 28-day cycles until documented progression, unmanageable toxicity, or decision to discontinue for any reason.

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-05-10
• Completion: 2016-05-10
• First posted: 2015-07-17
• Last updated: 2019-10-21
• Results posted: 2019-10-21

Locations

1 site across 1 country: United States