Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer
NCT ID: NCT00753545
Last Updated: 2025-02-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
265 participants
INTERVENTIONAL
2008-08-28
2023-10-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
AZD2281
AZD2281
Tablets Oral BID
2
matching placebo
matching placebo
matching placebo bid
Interventions
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AZD2281
Tablets Oral BID
matching placebo
matching placebo bid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have completed at least 2 previous courses of platinum containing therapy; the patient must have been platinum sensitive to the penultimate chemo regimen.
* For the last chemotherapy course prior to enrolment on the study, patients must have demonstrated an objective stable maintained response (partial or complete response) and this response needs to be maintained until completion of chemotherapy.
* Patients must be treated on the study within 8 wks of completion of their final dose of the platinum containing regimen.
Exclusion Criteria
* Patients with low grade ovarian carcinoma.
* Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study
* Patients receiving any chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry (or a longer period depending on the defined characteristics of the agents used).
18 Years
130 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Mika Sovak, BSc, MBCHB, MD
Role: STUDY_DIRECTOR
AstraZeneca
Prof Jonathan A Lederman
Role: PRINCIPAL_INVESTIGATOR
University College, London
Locations
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Research Site
Berkeley, California, United States
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San Francisco, California, United States
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West Hollywood, California, United States
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Sunrise, Florida, United States
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West Palm Beach, Florida, United States
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Indianapolis, Indiana, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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New York, New York, United States
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Providence, Rhode Island, United States
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Adelaide, , Australia
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East Bentleigh, , Australia
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Heidelberg, , Australia
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Melbourne, , Australia
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Nambour, , Australia
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Randwick, , Australia
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South Brisbane, , Australia
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Toorak Gardens, , Australia
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Innsbruck, , Austria
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Vienna, , Austria
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Wein, , Austria
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Brussels, , Belgium
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Leuven, , Belgium
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Vancouver, British Columbia, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Brno, , Czechia
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Brno, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Tallinn, , Estonia
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Tartu, , Estonia
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Bordeaux, , France
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Caen, , France
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Lyon, , France
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Nantes, , France
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Paris, , France
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Paris, , France
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Reims, , France
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Bonn, , Germany
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Düsseldorf, , Germany
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Essen, , Germany
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Freiburg im Breisgau, , Germany
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Göttingen, , Germany
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Hanover, , Germany
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Kiel, , Germany
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Marburg, , Germany
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München, , Germany
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Rostock, , Germany
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Ulm, , Germany
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Wiesbaden, , Germany
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Haifa, , Israel
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Holon, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Nahariya, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Ẕerifin, , Israel
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Amsterdam, , Netherlands
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Amsterdam, , Netherlands
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Bialystok, , Poland
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Grzepnica, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Baia Mare, , Romania
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Cluj-Napoca, , Romania
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Iași, , Romania
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Suceava, , Romania
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Barnaul, , Russia
Research Site
Obninsk, , Russia
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Orenburg, , Russia
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Perm, , Russia
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Pyatigorsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Voronezh, , Russia
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Yekaterinburg, , Russia
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Córdoba, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Valencia, , Spain
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Donetsk, , Ukraine
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Kharkiv Region, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Lutsk, , Ukraine
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Odesa, , Ukraine
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Odesa, , Ukraine
Research Site
Ternopil, , Ukraine
Research Site
Uzhhorod, , Ukraine
Research Site
Dundee, , United Kingdom
Research Site
Edinburgh, , United Kingdom
Research Site
London, , United Kingdom
Research Site
London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
Research Site
Metropolitan Borough of Wirral, , United Kingdom
Research Site
Northwood, , United Kingdom
Research Site
Sutton, , United Kingdom
Countries
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References
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Barnicle A, Ray-Coquard I, Rouleau E, Cadoo K, Simpkins F, Aghajanian C, Leary A, Poveda A, Lheureux S, Pujade-Lauraine E, You B, Ledermann J, Matulonis U, Gourley C, Timms KM, Lai Z, Hodgson DR, Elks CE, Dearden S, Egile C, Lao-Sirieix P, Harrington EA, Brown JS. Patterns of genomic instability in > 2000 patients with ovarian cancer across six clinical trials evaluating olaparib. Genome Med. 2024 Dec 18;16(1):145. doi: 10.1186/s13073-024-01413-5.
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.
Ledermann JA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Bennett B, Parry D, Spencer S, Mann H, Matulonis U. Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer. Br J Cancer. 2016 Nov 22;115(11):1313-1320. doi: 10.1038/bjc.2016.348. Epub 2016 Nov 8.
Ledermann JA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Rowe P, Lowe E, Hodgson D, Sovak MA, Matulonis U. Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: an updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Oncol. 2016 Nov;17(11):1579-1589. doi: 10.1016/S1470-2045(16)30376-X. Epub 2016 Sep 9.
Matulonis UA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Parry D, Grinsted L, Ledermann JA. Olaparib maintenance therapy in patients with platinum-sensitive, relapsed serous ovarian cancer and a BRCA mutation: Overall survival adjusted for postprogression poly(adenosine diphosphate ribose) polymerase inhibitor therapy. Cancer. 2016 Jun 15;122(12):1844-52. doi: 10.1002/cncr.29995. Epub 2016 Apr 8.
Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott CL, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Dougherty B, Orr M, Hodgson D, Barrett JC, Matulonis U. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncol. 2014 Jul;15(8):852-61. doi: 10.1016/S1470-2045(14)70228-1. Epub 2014 May 31.
Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Macpherson E, Watkins C, Carmichael J, Matulonis U. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med. 2012 Apr 12;366(15):1382-92. doi: 10.1056/NEJMoa1105535. Epub 2012 Mar 27.
Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81. doi: 10.1038/nrc2583.
Related Links
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Other Identifiers
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2008-003439-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D0810C00019
Identifier Type: -
Identifier Source: org_study_id
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