Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer
NCT ID: NCT00628251
Last Updated: 2019-12-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
97 participants
INTERVENTIONAL
2008-07-30
2018-09-19
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
NONE
Study Groups
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1
AZD2281 Oral 200 mg BID
AZD2281
200mg oral twice daily
2
Liposomal Doxorubicin
Liposomal Doxorubicin
50mg/m2 Monthly Intravenous
3
AZD2281 Oral 400 mg BID
AZD2281
400mg Oral twice daily
Interventions
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AZD2281
400mg Oral twice daily
Liposomal Doxorubicin
50mg/m2 Monthly Intravenous
AZD2281
200mg oral twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Progressive or recurrent disease after platinum-based chemotherapy
* Measurable disease by RECIST
Exclusion Criteria
* Brain metastases
* Less than 28 days since last treatment used to treat the disease
* Considered a poor medical risk due to a serious uncontrolled disorder
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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Jane Robertson, BSc, MBCHB, MD
Role: STUDY_DIRECTOR
AstraZeneca
Stan Kaye, BSc, MB, FRCP, FRCR, SMedSCi
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden NHS Foundation Trust
Locations
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Research Site
Los Angeles, California, United States
Research Site
San Francisco, California, United States
Research Site
Boca Raton, Florida, United States
Research Site
Boston, Massachusetts, United States
Research Site
New York, New York, United States
Research Site
Houston, Texas, United States
Research Site
East Melbourne, , Australia
Research Site
Melbourne, Parkville, , Australia
Research Site
Randwick, , Australia
Research Site
Leuven, , Belgium
Research Site
Cologne, , Germany
Research Site
München, , Germany
Research Site
Haifa, , Israel
Research Site
Ramat Gan, , Israel
Research Site
Tel Aviv, , Israel
Research Site
Szczecin, , Poland
Research Site
Barcelona, , Spain
Research Site
Hospitalet deLlobregat, , Spain
Research Site
Lund, , Sweden
Research Site
Cambridge, , United Kingdom
Research Site
Edinburgh, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Sutton, , United Kingdom
Countries
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References
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Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
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.
Penson RT, Valencia RV, Cibula D, Colombo N, Leath CA 3rd, Bidzinski M, Kim JW, Nam JH, Madry R, Hernandez C, Mora PAR, Ryu SY, Milenkova T, Lowe ES, Barker L, Scambia G. Olaparib Versus Nonplatinum Chemotherapy in Patients With Platinum-Sensitive Relapsed Ovarian Cancer and a Germline BRCA1/2 Mutation (SOLO3): A Randomized Phase III Trial. J Clin Oncol. 2020 Apr 10;38(11):1164-1174. doi: 10.1200/JCO.19.02745. Epub 2020 Feb 19.
Matulonis UA, Penson RT, Domchek SM, Kaufman B, Shapira-Frommer R, Audeh MW, Kaye S, Molife LR, Gelmon KA, Robertson JD, Mann H, Ho TW, Coleman RL. Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: a multistudy analysis of response rates and safety. Ann Oncol. 2016 Jun;27(6):1013-1019. doi: 10.1093/annonc/mdw133. Epub 2016 Mar 8.
Ang JE, Gourley C, Powell CB, High H, Shapira-Frommer R, Castonguay V, De Greve J, Atkinson T, Yap TA, Sandhu S, Banerjee S, Chen LM, Friedlander ML, Kaufman B, Oza AM, Matulonis U, Barber LJ, Kozarewa I, Fenwick K, Assiotis I, Campbell J, Chen L, de Bono JS, Gore ME, Lord CJ, Ashworth A, Kaye SB. Efficacy of chemotherapy in BRCA1/2 mutation carrier ovarian cancer in the setting of PARP inhibitor resistance: a multi-institutional study. Clin Cancer Res. 2013 Oct 1;19(19):5485-93. doi: 10.1158/1078-0432.CCR-13-1262. Epub 2013 Aug 6.
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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CSR\_Synopsis\_D0810C00012.pdf
Other Identifiers
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D0810C00012
Identifier Type: -
Identifier Source: org_study_id
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