Ovarian CancerPhase 2NCT01081951
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
A Phase 2 study testing olaparib, paclitaxel and carboplatin in people with Ovarian Cancer, run by AstraZeneca at 53 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 125 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- olaparib, paclitaxel and carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 53 sitesin 13 countries
- Study dates
- 4 Feb 2010to 31 Dec 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 125 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
53 sites in 13 countries.
53 sites in 13 countries
United States8 sites
Research Site
Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02215
Research Site
Indianapolis, Indiana, 46202
Research Site
New York, New York, 10016
Research Site
Orlando, Florida, 32806
Research Site
Portland, Oregon, 97227-1191
Research Site
Stanford, California, 94305
Research Site
West Hollywood, California, 90048
Japan7 sites
Research Site
Chūōku, 104-0045
Research Site
Fukuoka, 811-1395
Research Site
Matsuyama, 791-0280
Research Site
Morioka, 028-3695
Research Site
Shinjuku-ku, 160-8582
Research Site
Yamagata, 990-9585
Research Site
Yonago-shi, 683-8504
Canada6 sites
Research Site
Hamilton, Ontario, L8V 5C2
Research Site
Québec, Quebec, G1R 2J6
Research Site
Sherbrooke, Quebec, J1H 5N4
Research Site
Toronto, Ontario, M4N 3M5
Research Site
Toronto, Ontario, M5G 2M9
Research Site
Vancouver, British Columbia, V5Z 4E6
Czechia5 sites
Research Site
Brno, 625 00
Research Site
Brno, 656 53
Research Site
Hradec Králové, 500 05
Research Site
Olomouc, 775 20
Research Site
Prague, 120 00
Germany5 sites
Research Site
Essen, 45147
Research Site
Frankfurt, 60590
Research Site
Hamburg, 20246
Research Site
München, 81675
Research Site
Solingen, 42653
Belgium4 sites
Research Site
Brussels, 1090
Research Site
Leuven, 3000
Research Site
Namur, 5000
Research Site
Wilrijk, 2610
Italy4 sites
Research Site
Genova, 16132
Research Site
Milan, 20141
Research Site
Monza, 20052
Research Site
Torino, 10126
Netherlands4 sites
Research Site
Amsterdam, 1066 CX
Research Site
Amsterdam, 1105 AZ
Research Site
Nijmegen, 6525 GA
Research Site
Rotterdam, 3015 GD
United Kingdom3 sites
Research Site
Birmingham, B18 7QH
Research Site
Coventry, CV2 2DX
Research Site
Edinburgh, EH4 2XR
About this study
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
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
- Ovarian Cancer
- Being tested
- olaparib, paclitaxel, carboplatin, Drug: carboplatin
- Keywords
- Poly(ADP ribose), polymerisation (PARP), Platinum sensitive, Advanced Serous Ovarian cancer, olaparib, PARP inhibitors, Platinum Sensitive Advanced Serous Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olaparibDrug
Also called Lynparza
Tablets Oral BID
paclitaxelDrug
Also called Taxol
175mg/m2 iv for 6 cycles (18 weeks) day 1 of 21 day cycle
carboplatinDrug
AUC6 iv for 6 cycles (18 weeks) day 1 of 21 day cycle
paclitaxelDrug
175mg/m2 iv for up to 6 cycles (18 weeks)
Drug: carboplatinDrug
AUC4 iv for up to 6 cycles (18 weeks)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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. Receives: Drug: olaparib; Drug: paclitaxel; Drug: Drug: carboplatin |
| 2 | Active comparator | paclitaxel iv and carboplatin iv Receives: Drug: paclitaxel; Drug: carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
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).
Measured: 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)
Secondary outcomes (2)
Overall Survival (OS)
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. Updated OS based on final OS analysis (DCO 31 January 2014)
Measured: Following disease progression, patients will be contacted every 12 weeks to assess survival status until the final analysis (approximately 50 months)
Percentage Change in Tumour Size
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.
Measured: Week 9 (+/- 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study start4 Feb 2010
- Primary completion10 Oct 2011
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jane Robertson, BSc, MBCHB, MD, Study director, AstraZenecaAmit Oza, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081951
- Sponsor's protocol ID
- D0810C00041
- Other IDs
- 2009-015970-36, 2009
- Status last verified
- Aug 2026
- First submitted
- 26 Feb 2010
- Last updated
- 5 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
- Expanded access
- Available
Publications
Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.
PubMed 35170751Gunderson CC, Moore KN. PARP inhibition in ovarian cancer: state of the science. Gynecol Oncol. 2015 Jan;136(1):8-10. doi: 10.1016/j.ygyno.2014.12.009. No abstract available.
PubMed 25554012Oza AM, Cibula D, Benzaquen AO, Poole C, Mathijssen RH, Sonke GS, Colombo N, Spacek J, Vuylsteke P, Hirte H, Mahner S, Plante M, Schmalfeldt B, Mackay H, Rowbottom J, Lowe ES, Dougherty B, Barrett JC, Friedlander M. Olaparib combined with chemotherapy for recurrent platinum-sensitive ovarian cancer: a randomised phase 2 trial. Lancet Oncol. 2015 Jan;16(1):87-97. doi: 10.1016/S1470-2045(14)71135-0. Epub 2014 Dec 4.
PubMed 25481791