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

PHASE1TerminatedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

May 10, 2016

Study Completion Date

May 10, 2016

Conditions
Metastatic Prostate Cancer
Interventions
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.

Trial Locations (1)

02111

Tufts Medical Center, Boston

Sponsors
All Listed Sponsors
collaborator

Hoosier Cancer Research Network

OTHER

collaborator

Tesaro, Inc.

INDUSTRY

lead

Paul Mathew, MD

OTHER