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
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01081951 |
Recruitment Status :
Active, not recruiting
First Posted : March 5, 2010
Results First Posted : December 10, 2012
Last Update Posted : April 5, 2022
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Cancer | Drug: olaparib Drug: paclitaxel Drug: carboplatin Drug: Drug: carboplatin | Phase 2 |
Expanded Access : An investigational treatment associated with this study has been approved for sale to the public. More info ...
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 162 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Open Label Randomised Comparative Multicentre Study to Compare the Efficacy and Tolerability of Olaparib in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone in Patients With Platinum Sensitive Advanced Serous Ovarian Cancer |
Actual Study Start Date : | February 12, 2010 |
Actual Primary Completion Date : | October 10, 2011 |
Estimated Study Completion Date : | December 30, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator. Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions. |
Drug: olaparib
Tablets Oral BID
Other Name: Lynparza Drug: paclitaxel 175mg/m2 iv for up to 6 cycles (18 weeks) Drug: Drug: carboplatin AUC4 iv for up to 6 cycles (18 weeks) |
Active Comparator: 2
paclitaxel iv and carboplatin iv
|
Drug: paclitaxel
175mg/m2 iv for 6 cycles (18 weeks) day 1 of 21 day cycle
Other Name: Taxol Drug: carboplatin AUC6 iv for 6 cycles (18 weeks) day 1 of 21 day cycle |
- Progression Free Survival (PFS) [ Time Frame: 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).
- Overall Survival (OS) [ Time Frame: Following disease progression, patients will be contacted every 12 weeks to assess survival status until the final analysis (approximately 50 months) ]OS was defined as the time from randomisation until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive.
- Percentage Change in Tumour Size [ Time Frame: Week 9 (+/- 1 week) ]The total tumour size was defined as the sum of the longest diameters of the target lesions. At week 9, the percentage change in tumour size was calculated as [(week 9 sum of target lesions - baseline sum of target lesions)/baseline sum of target lesions]*100 for each patient. Imputations were used for missing data where possible.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 125 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081951

Study Director: | Jane Robertson, BSc, MBCHB, MD | AstraZeneca | |
Principal Investigator: | Amit Oza, MD | Princess Margaret Hospital, Canada |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01081951 |
Other Study ID Numbers: |
D0810C00041 |
First Posted: | March 5, 2010 Key Record Dates |
Results First Posted: | December 10, 2012 |
Last Update Posted: | April 5, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
Time Frame: | AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
Access Criteria: | When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
URL: | https://astrazenecagroup-dt.pharmacm.com/DT/Home |
Poly(ADP ribose) polymerisation (PARP) Platinum sensitive Advanced Serous Ovarian cancer |
olaparib PARP inhibitors Platinum Sensitive Advanced Serous Ovarian Cancer |
Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Paclitaxel Albumin-Bound Paclitaxel Carboplatin Olaparib Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Poly(ADP-ribose) Polymerase Inhibitors Enzyme Inhibitors |