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Clinical Trials in Italy / NCT01081951
Active, not recruiting Phase 2

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 Italy 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
No
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)

FacilityCityRegionStatus
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 →

More AstraZeneca trials in Italy

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AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer Recruiting
Acalabrutinib Real World Italian obSErvational Study -ARISE Active, not recruiting
Observational Study on the Clinical Profile of Patients With Uncontrolled Severe Asthma Treated With Tezepelumab in Italy Active, not recruiting

Other trials for the same condition

Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01) Recruiting
Evaluating Efficacy and Tolerability of Anticancer Drug Therapies for the Treatment of Gynecologic and Breast Cancers Recruiting
A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103) Recruiting
Oregovomab Plus Chemo in Newly Diagnosed Patients With Advanced Epithelial Ovarian Cancer Following Optimal Debulking Surgery Active, not recruiting
Measure of Outcomes in Patients With Advanced Ovarian Cancer According to Homologous Recombination Status and Matched Therapies in a Real-world Scenario 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 Italy