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
NCT ID: NCT01081951
Last Updated: 2025-11-13
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
162 participants
INTERVENTIONAL
2010-02-04
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
olaparib
Tablets Oral BID
paclitaxel
175mg/m2 iv for up to 6 cycles (18 weeks)
Drug: carboplatin
AUC4 iv for up to 6 cycles (18 weeks)
2
paclitaxel iv and carboplatin iv
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
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Hypersensitivity to pre medications required for treatment with paclitaxel/carboplatin
18 Years
125 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Jane Robertson, BSc, MBCHB, MD
Role: STUDY_DIRECTOR
AstraZeneca
Amit Oza, MD
Role: PRINCIPAL_INVESTIGATOR
Princess Margaret Hospital, Canada
Locations
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Research Site
Stanford, California, United States
Research Site
West Hollywood, California, United States
Research Site
Orlando, Florida, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Boston, Massachusetts, United States
Research Site
Boston, Massachusetts, United States
Research Site
New York, New York, United States
Research Site
Portland, Oregon, United States
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, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Québec, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada
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
Research Site
Yonago-shi, , Japan
Research Site
Amsterdam, , Netherlands
Research Site
Amsterdam, , Netherlands
Research Site
Nijmegen, , Netherlands
Research Site
Rotterdam, , Netherlands
Research Site
Panama City, , Panama
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Madrid, , Spain
Research Site
Valencia, , Spain
Research Site
Birmingham, , United Kingdom
Research Site
Coventry, , United Kingdom
Research Site
Edinburgh, , United Kingdom
Countries
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References
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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.
Related Links
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Other Identifiers
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2009-015970-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D0810C00041
Identifier Type: -
Identifier Source: org_study_id