AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer
NCT ID: NCT00610714
Last Updated: 2012-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
211 participants
INTERVENTIONAL
2008-04-30
2012-01-31
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
TRIPLE
Study Groups
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Active Comparator
carboplatin plus paclitaxel
Carboplatin
intravenous injection
Paclitaxel
intravenous infusion
2
AZD0530 in combination with carboplatin plus paclitaxel
AZD0530
oral once daily dose
Carboplatin
intravenous injection
Paclitaxel
intravenous infusion
Interventions
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AZD0530
oral once daily dose
Carboplatin
intravenous injection
Paclitaxel
intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have evidence of recurrence or disease progression at least 6 months following treatment cessation of 1st or 2nd line platinum containing therapy
* Estimated life expectancy of more than 12 weeks
Exclusion Criteria
* Received more than 2 prior chemotherapy regimens for ovarian cancer treatment
* Inadequate bone marrow reserve
* Inadequate liver function, renal function or low haemoglobin
* Pregnant, breastfeeding or if of child-bearing status unwilling to use an acceptable method of contraception
18 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Chris Poole, Prof
Role: PRINCIPAL_INVESTIGATOR
Dept. of Oncology, University Hospital, Clifford Bridge Road, Walsgrave, Coventry
Mireille Cantarini, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Pleven, , Bulgaria
Research Site
Plovdiv, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Varna, , Bulgaria
Research Site
Edmonton, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada
Research Site
Aalborg, , Denmark
Research Site
Herning, , Denmark
Research Site
Næstved, , Denmark
Research Site
Paris, Cedex 04, France
Research Site
Avignon, , France
Research Site
Bordeaux, , France
Research Site
Caen, , France
Research Site
Lyon, , France
Research Site
Montpellier, , France
Research Site
Nantes, , France
Research Site
Pierre-Bénite, , France
Research Site
Reims, , France
Research Site
Vandœuvre-lès-Nancy, , France
Research Site
Amsterdam, , Netherlands
Research Site
Leiden, , Netherlands
Research Site
Nijmegen, , Netherlands
Research Site
The Hague, , Netherlands
Research Site
Bergen, , Norway
Research Site
Oslo, , Norway
Research Site
Lima, Lima Province, Peru
Research Site
Coimbra, , Portugal
Research Site
Funchal, , Portugal
Research Site
Lisbon, , Portugal
Research Site
Porto, , Portugal
Research Site
Baia Mare, Maramureş, Romania
Research Site
Alba Iulia, , Romania
Research Site
Bucharest, , Romania
Research Site
Cluj-Napoca, , Romania
Research Site
Kazan', , Russia
Research Site
Moscow, , Russia
Research Site
Nizhny Novgorod, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Córdoba, Andalusia, Spain
Research Site
Barcelona, Catalonia, Spain
Research Site
Hospitalet Dellobregat(barcelo, Catalonia, Spain
Research Site
Madrid, Madrid, Spain
Research Site
Valencia, Valencia, Spain
Research Site
Coventry, , United Kingdom
Countries
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References
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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.
Other Identifiers
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AZD0530 Study 15
Identifier Type: -
Identifier Source: secondary_id
D8180C00015
Identifier Type: -
Identifier Source: org_study_id