Study of Olaparib Maintenance Following Cabazitaxel-Carbo in Men With AVPC

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

October 3, 2017

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Prostate Cancer AggressivenessProstate Carcinoma
Interventions
DRUG

Cabazitaxel

25mg/m2 administered intravenously over 60 minutes on day 1 of cycles 1-6; given before carboplatin.

DRUG

Carboplatin

AUC 4 administered intravenously over 60 minutes on day 1 of cycles 1-6

DRUG

Prednisone 5Mg

5 mg administered by mouth twice daily on days 1-21 of cycles 1-6.

DRUG

Olaparib

Administered by mouth twice daily at a dose of 300 mg by mouth twice daily, dispensed on Day 1 of cycle 7 to participants randomized to receive olaparib maintenance and every 21 days thereafter until the participant completes the study, withdraws from the study or the closure of the study.

Trial Locations (1)

77030

MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER