Phase I/II AZD8931/Paclitaxel in Treatment of Advanced Solid Tumours (Phase I) and Advanced Breast Cancer (Phase II)
NCT ID: NCT00900627
Last Updated: 2016-01-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
330 participants
INTERVENTIONAL
2009-06-30
2015-02-28
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
AZD8931 plus Paclitaxel
AZD8931
Tablet Oral bid
Paclitaxel
IV once weekly for 3 weeks followed by a week off (repeated cycles)
2
Placebo plus Paclitaxel
Paclitaxel
IV once weekly for 3 weeks followed by a week off (repeated cycles)
Placebo
Oral bid (twice daily)
Interventions
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AZD8931
Tablet Oral bid
Paclitaxel
IV once weekly for 3 weeks followed by a week off (repeated cycles)
Placebo
Oral bid (twice daily)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Suitable for paclitaxel chemotherapy
* Life expectancy more than 12 weeks
Exclusion Criteria
* Hypersensitive to paclitaxel
* No symptomatic uncontrolled brain metastases
* Previous taxane chemotherapy within 12 months (Phase II)
18 Years
150 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Dr Serban Ghiorghiu
Role: STUDY_DIRECTOR
AstraZeneca
Professor Jose Baselga
Role: PRINCIPAL_INVESTIGATOR
Vall d'Hebron University Hospital
Locations
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Research Site
Brussels (Jette), , Belgium
Research Site
Leuven, , Belgium
Research Site
Namur, , Belgium
Research Site
Sint-Niklaas, , Belgium
Research Site
São Paulo, , Brazil
Research Site
Sofia, , Bulgaria
Research Site
Stara Zagora, , Bulgaria
Research Site
Varna, , Bulgaria
Research Site
Vratsa, , Bulgaria
Research Site
Halifax, Nova Scotia, Canada
Research Site
London, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Brno, , Czechia
Research Site
Jičín, , Czechia
Research Site
Olomouc, , Czechia
Research Site
Prague, , Czechia
Research Site
Praha 4 - Krc, , Czechia
Research Site
Znojmo, , Czechia
Research Site
Villejuif, , France
Research Site
Budapest, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Győr, , Hungary
Research Site
Szeged, , Hungary
Research Site
Lido di Camaiore, , Italy
Research Site
Modena, , Italy
Research Site
Treviglio, , Italy
Research Site
Panama City, , Panama
Research Site
Lima, , Peru
Research Site
Barcelona, , Spain
Research Site
Madrid, , Spain
Research Site
Valencia, , Spain
Research Site
Uppsala, , Sweden
Research Site
Chur, , Switzerland
Research Site
Glasgow, , United Kingdom
Research Site
Leicester, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Nottingham, , United Kingdom
Research Site
Surrey, , United Kingdom
Countries
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Other Identifiers
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D0102C00003
Identifier Type: -
Identifier Source: org_study_id
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