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 | Active Not Recruiting Phase 2 Results

• 2 other identifiers: D0810C000412009-015970-36
• Study Type: interventional
• Target: 162
• Locations: 13 countries
• Sites: 53

Brief 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.

Conditions

Ovarian Cancer

Keywords

Poly(ADP ribose); polymerisation (PARP); Platinum sensitive; Advanced Serous Ovarian cancer; olaparib; PARP inhibitors; Platinum Sensitive Advanced Serous Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall Survival (OS)

  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

  Week 9 (+/- 1 week)

Study Arms (2)

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.

Drug: olaparib; Drug: paclitaxel; Drug: Drug: carboplatin

2

ACTIVE COMPARATOR

paclitaxel iv and carboplatin iv

Drug: paclitaxel; Drug: carboplatin

Interventions

olaparib DRUG

Tablets Oral BID

Also known as: Lynparza

1

paclitaxel DRUG

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

Also known as: Taxol

2

carboplatin DRUG

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

2

Drug: carboplatin DRUG

AUC4 iv for up to 6 cycles (18 weeks)

1

Eligibility Criteria

• Age: 18 Years - 125 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (53)

Research Site

Stanford, California, 94305, United States

Location

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West Hollywood, California, 90048, United States

Location

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Orlando, Florida, 32806, United States

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Indianapolis, Indiana, 46202, United States

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Boston, Massachusetts, 02114, United States

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Boston, Massachusetts, 02215, United States

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New York, New York, 10016, United States

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Portland, Oregon, 97227-1191, United States

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Parkville, 3050, Australia

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Randwick, 2031, Australia

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Brussels, 1090, Belgium

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Leuven, 3000, Belgium

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Namur, 5000, Belgium

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Wilrijk, 2610, Belgium

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Vancouver, British Columbia, V5Z 4E6, Canada

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Hamilton, Ontario, L8V 5C2, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Québec, Quebec, G1R 2J6, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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Brno, 625 00, Czechia

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Brno, 656 53, Czechia

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Hradec Králové, 500 05, Czechia

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Olomouc, 775 20, Czechia

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Prague, 120 00, Czechia

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Essen, 45147, Germany

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Frankfurt, 60590, Germany

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Hamburg, 20246, Germany

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München, 81675, Germany

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Solingen, 42653, Germany

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Genova, 16132, Italy

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Milan, 20141, Italy

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Monza, 20052, Italy

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Torino, 10126, Italy

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Chūōku, 104-0045, Japan

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Fukuoka, 811-1395, Japan

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Matsuyama, 791-0280, Japan

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Morioka, 028-3695, Japan

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Shinjuku-ku, 160-8582, Japan

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Yamagata, 990-9585, Japan

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Yonago-shi, 683-8504, Japan

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Amsterdam, 1066 CX, Netherlands

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Amsterdam, 1105 AZ, Netherlands

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Nijmegen, 6525 GA, Netherlands

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Rotterdam, 3015 GD, Netherlands

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Panama City, 2723, Panama

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Lima, LIMA 27, Peru

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Lima, LIMA 41, Peru

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Madrid, 08035, Spain

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Valencia, 46010, Spain

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Birmingham, B18 7QH, United Kingdom

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Coventry, CV2 2DX, United Kingdom

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Edinburgh, EH4 2XR, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 35170751 DERIVED

• 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.

  PMID: 25554012 DERIVED

• 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.

  PMID: 25481791 DERIVED

Related Links

• CSR-D0810C00041.pdf

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

olaparib; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Jane Robertson, BSc, MBCHB, MD

  AstraZeneca

  STUDY DIRECTOR

• Amit Oza, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 5, 2010
• Study Start: February 4, 2010
• Primary Completion: October 10, 2011
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 5, 2026
• Results First Posted: December 10, 2012

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

PE (2); ES (2); AU (2); PA (1); CA (6); DE (5); GB (3); CZ (5); IT (4); JP (7); US (8); BE (4); NL (4)