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

NCT03263650 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-02-17

No results posted yet for this study

Summary

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.

Conditions

  • Prostate Cancer Aggressiveness
  • Prostate 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.

Sponsors & Collaborators

Principal Investigators

  • Ana M. Aparicio, MD · UT MD Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-03
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03263650 on ClinicalTrials.gov