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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03263650
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabazitaxel — DRUG
    25mg/m2 administered intravenously over 60 minutes on day 1 of cycles 1-6; given before carboplatin.
  • Carboplatin — DRUG
    AUC 4 administered intravenously over 60 minutes on day 1 of cycles 1-6
  • Prednisone 5Mg — DRUG
    5 mg administered by mouth twice daily on days 1-21 of cycles 1-6.
  • Olaparib — DRUG
    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.

Study Details

The goal of this clinical research study is to learn if olaparib, when given after treatment with cabazitaxel, carboplatin, and prednisone, can help to control aggressive variant prostate cancer (AVPC). The safety of these drugs will also be studied. This is an investigational study. Cabazitaxel and carboplatin are FDA approved and commercially available for the treatment of certain types of prostate cancer. Prednisone is FDA-approved and commercially available as a corticosteroid. Olaparib is FDA approved and commercially available for the treatment of certain types of ovarian cancer. The combination of cabazitaxel and carboplatin followed by olaparib in this study is investigational. The study doctor can describe how the study drugs are designed to work. Up to 96 participants will be enrolled on this study. All will take part at MD Anderson.

Key Dates

Start date
Oct 3, 2017
Status verified
Feb 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
96 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cabazitaxel + Carboplatin
    Cabazitaxel, Cabazitaxel and Carboplatin intravenously on day 1 of cycles 1-6. Prednisone by mouth twice daily on days 1-21 of cycles 1-6.
  • Experimental: Olaparib Maintenance
    Participants randomized to receive Olaparib by mouth twice daily on Day 1 of cycle 7.
  • No Intervention: Observation Only
    Participants randomized to observation only beginning cycle 7.

Primary Outcome Measure

Progression-free survival (PFS) of men with AVPC treated with 6 cycles of cabazitaxel + carboplatin followed by olaparib maintenance versus observation [ Time Frame: Up to one year from time of randomization ]

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
MD Anderson Cancer Center· Houston, TX

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