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 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: olaparib; Drug: paclitaxel; Drug: paclitaxel; Drug: Drug: carboplatin; Drug: carboplatin

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Phase 2

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

Study Locations

• Australia
  • Parkville, Australia, 3050
    • Research Site
  • Randwick, Australia, 2031
    • Research Site
• Belgium
  • Brussels, Belgium, 1090
    • Research Site
  • Leuven, Belgium, 3000
    • Research Site
  • Namur, Belgium, 5000
    • Research Site
  • Wilrijk, Belgium, 2610
    • Research Site
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Research Site
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Research Site
    • Toronto, Ontario, Canada, M5G 2M9
      • Research Site
    • Toronto, Ontario, Canada, M4N 3M5
      • Research Site
  • Quebec
    • Québec, Quebec, Canada, G1R 2J6
      • Research Site
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Research Site
• Czechia
  • Brno, Czechia, 656 53
    • Research Site
  • Brno, Czechia, 625 00
    • Research Site
  • Hradec Králové, Czechia, 500 05
    • Research Site
  • Olomouc, Czechia, 775 20
    • Research Site
  • Prague, Czechia, 120 00
    • Research Site
• Germany
  • Essen, Germany, 45147
    • Research Site
  • Frankfurt, Germany, 60590
    • Research Site
  • Hamburg, Germany, 20246
    • Research Site
  • München, Germany, 81675
    • Research Site
  • Solingen, Germany, 42653
    • Research Site
• Italy
  • Genova, Italy, 16132
    • Research Site
  • Milan, Italy, 20141
    • Research Site
  • Monza, Italy, 20052
    • Research Site
  • Torino, Italy, 10126
    • Research Site
• Japan
  • Chūōku, Japan, 104-0045
    • Research Site
  • Fukuoka, Japan, 811-1395
    • Research Site
  • Matsuyama, Japan, 791-0280
    • Research Site
  • Morioka, Japan, 028-3695
    • Research Site
  • Shinjuku-ku, Japan, 160-8582
    • Research Site
  • Yamagata, Japan, 990-9585
    • Research Site
  • Yonago-shi, Japan, 683-8504
    • Research Site
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Research Site
  • Amsterdam, Netherlands, 1105 AZ
    • Research Site
  • Nijmegen, Netherlands, 6525 GA
    • Research Site
  • Rotterdam, Netherlands, 3015 GD
    • Research Site
• Panama
  • Panama City, Panama, 2723
    • Research Site
• Peru
  • Lima, Peru, LIMA 27
    • Research Site
  • Lima, Peru, LIMA 41
    • Research Site
• Spain
  • Madrid, Spain, 08035
    • Research Site
  • Valencia, Spain, 46010
    • Research Site
• United Kingdom
  • Birmingham, United Kingdom, B18 7QH
    • Research Site
  • Coventry, United Kingdom, CV2 2DX
    • Research Site
  • Edinburgh, United Kingdom, EH4 2XR
    • Research Site
• United States
  • California
    • Stanford, California, United States, 94305
      • Research Site
    • West Hollywood, California, United States, 90048
      • Research Site
  • Florida
    • Orlando, Florida, United States, 32806
      • Research Site
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Research Site
    • Boston, Massachusetts, United States, 02215
      • Research Site
  • New York
    • New York, New York, United States, 10016
      • Research Site
  • Oregon
    • Portland, Oregon, United States, 97227-1191
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 125 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Lynparza; Drug: paclitaxel; 175mg/m2 iv for 6 cycles (18 weeks) day 1 of 21 day cycle; Other Names: Taxol; 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 Names: Taxol; Drug: paclitaxel; 175mg/m2 iv for up to 6 cycles (18 weeks); Drug: carboplatin; AUC6 iv for 6 cycles (18 weeks) day 1 of 21 day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 9 (+/- 1 week)
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)	Following disease progression, patients will be contacted every 12 weeks to assess survival status until the final analysis (approximately 50 months)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Jane Robertson, BSc, MBCHB, MD, AstraZeneca; Principal Investigator: Amit Oza, MD, Princess Margaret Hospital, Canada

Publications and helpful links

General 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.
• Gunderson 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.
• Oza 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.

Helpful Links

• CSR-D0810C00041.pdf

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2010
• Primary Completion (Actual): October 10, 2011
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 26, 2010
• First Submitted That Met QC Criteria: March 4, 2010
• First Posted (Estimated): March 5, 2010

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: olaparib; Platinum sensitive; PARP inhibitors; Poly(ADP ribose); polymerisation (PARP); Advanced Serous Ovarian cancer; Platinum Sensitive Advanced Serous Ovarian Cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Ovarian Neoplasms; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Coordination Complexes; Taxoids; Cyclodecanes; Diterpenes; Carboplatin; Paclitaxel; olaparib
• Other Study ID Numbers: D0810C00041; 2009-015970-36 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP