A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)
NCT ID: NCT00516373
Last Updated: 2024-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
98 participants
INTERVENTIONAL
2005-07-11
2023-04-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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KU-0059436
KU-0059436 administered orally twice daily
KU-0059436 (AZD2281)(PARP inhibitor)
oral
Interventions
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KU-0059436 (AZD2281)(PARP inhibitor)
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
130 Years
ALL
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
Dr. Johann De Bono, PhD MRCP FRCR
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden Hospital Trust, London, UK
Locations
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Research Site
Brussels, , Belgium
Research Site
Amsterdam, , Netherlands
Research Site
Szczecin, , Poland
Research Site
Edinburgh, , United Kingdom
Research Site
London, , United Kingdom
Countries
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References
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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.
Fong PC, Boss DS, Yap TA, Tutt A, Wu P, Mergui-Roelvink M, Mortimer P, Swaisland H, Lau A, O'Connor MJ, Ashworth A, Carmichael J, Kaye SB, Schellens JH, de Bono JS. Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers. N Engl J Med. 2009 Jul 9;361(2):123-34. doi: 10.1056/NEJMoa0900212. Epub 2009 Jun 24.
Related Links
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CSR\_Synopsis\_D0810C00002(KU36-92).pdf
Other Identifiers
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D0810C00002
Identifier Type: -
Identifier Source: secondary_id
2005-001435-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KU36-92
Identifier Type: -
Identifier Source: org_study_id
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