Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer

NCT01081951 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2026-05-13

Study results available
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Summary

To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4) when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian cancer.

Conditions

Interventions

DRUG

olaparib

Tablets Oral BID

DRUG

paclitaxel

175mg/m2 iv for 6 cycles (18 weeks) day 1 of 21 day cycle

DRUG

carboplatin

AUC6 iv for 6 cycles (18 weeks) day 1 of 21 day cycle

DRUG

paclitaxel

175mg/m2 iv for up to 6 cycles (18 weeks)

DRUG

Drug: carboplatin

AUC4 iv for up to 6 cycles (18 weeks)

Sponsors & Collaborators

Principal Investigators

  • Jane Robertson, BSc, MBCHB, MD · AstraZeneca

  • Amit Oza, MD · Princess Margaret Hospital, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
125 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-04
Primary Completion
2011-10-10
Completion
2026-12-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Panama
  • Peru
  • Spain
  • United Kingdom

Study Locations

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Entities

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 NCT01081951 on ClinicalTrials.gov