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 · tracked via the Priya Life Science Netherlands tracker

Sponsor

AstraZeneca

Phase

Phase 2

Started

2010-02-04

Last updated

2026-08-05

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

olaparib →paclitaxel →carboplatin →paclitaxel →Drug: carboplatin →

olaparib: Tablets Oral BID

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

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

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

Drug: carboplatin: AUC4 iv for up to 6 cycles (18 weeks)

Study 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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

125 Years

Healthy volunteers

Inclusion Criteria: * Diagnosed with serous ovarian cancer * Patients who have received no more than 3 previous platinum containing treatments and were progression free for at least 6 months following the end of the last platinum treatment * At least one lesion that is suitable for accurate repeated measurements Exclusion Criteria: * Patients receiving any systemic anticancer chemotherapy, radiotherapy (except palliative) within two weeks from the last dose prior to study treatment * Hypersensitivity to pre medications required for treatment with paclitaxel/carboplatin

Primary outcome measure(s)

Progression Free Survival (PFS) — Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months)
PFS (based on independent central review) was defined as the time from randomisation until objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression).

Trial sites (53)

Facility	City	Region
Research Site	Stanford	California
Research Site	West Hollywood	California
Research Site	Orlando	Florida
Research Site	Indianapolis	Indiana
Research Site	Boston	Massachusetts
Research Site	Boston	Massachusetts
Research Site	New York	New York
Research Site	Portland	Oregon
Research Site	Parkville	Australia
Research Site	Randwick	Australia
Research Site	Brussels	Belgium
Research Site	Leuven	Belgium
Research Site	Namur	Belgium
Research Site	Wilrijk	Belgium
Research Site	Vancouver	British Columbia
Research Site	Hamilton	Ontario
Research Site	Toronto	Ontario
Research Site	Toronto	Ontario
Research Site	Québec	Quebec
Research Site	Sherbrooke	Quebec
Research Site	Brno	Czechia
Research Site	Brno	Czechia
Research Site	Hradec Králové	Czechia
Research Site	Olomouc	Czechia
Research Site	Prague	Czechia
Research Site	Essen	Germany
Research Site	Frankfurt	Germany
Research Site	Hamburg	Germany
Research Site	München	Germany
Research Site	Solingen	Germany
Research Site	Genova	Italy
Research Site	Milan	Italy
Research Site	Monza	Italy
Research Site	Torino	Italy
Research Site	Chūōku	Japan
Research Site	Fukuoka	Japan
Research Site	Matsuyama	Japan
Research Site	Morioka	Japan
Research Site	Shinjuku-ku	Japan
Research Site	Yamagata	Japan

+ 13 more sites — see the full list on the official registry below.

On this site

📄 Lynparza (olaparib) drug profile →

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Other trials for the same condition

Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression Recruiting

Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65). Active, not recruiting

Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Active, not recruiting

Utility of Adjusting Chemotherapy Dose & Dosing Schedule With the SALVage Weekly Dose-dense Regimen in Patients With Poor Prognostic OVARian Cancers Based on the Tumor Unfavorable Primary Chemosensitivity and Incomplete Debulking Surgery Recruiting

OveRcoming immunosupprEssion aNd rebAlancing the Immune reSponSe in ovAriaN CancEr Study Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01081951 on ClinicalTrials.gov ↗ ← All trials in the Netherlands