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Brief Title: Phase I/II AZD8931/Paclitaxel in Treatment of Advanced Solid Tumours (Phase I) and Advanced Breast Cancer (Phase II)
Official Title: A Phase I/II Multi-centre Study of AZD8931 in Combination With Weekly Paclitaxel to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and in a Selected Population With Low HER2-expressing Locally Recurrent and/or Metastatic Breast Cancer
Study ID: NCT00900627
Brief Summary: The main purpose of this study is to determine if AZD8931 can improve the efficacy of standard chemotherapy for the treatment of advanced breast cancer. This study will be conducted in 2 parts: the first part (phase I) will determine a dose of AZD8931 that can be safely administered with paclitaxel chemotherapy. The second part (phase II) will determine the efficacy and safety of AZD8931 in combination with paclitaxel chemotherapy in breast cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Brussels (Jette), , Belgium
Research Site, Leuven, , Belgium
Research Site, Namur, , Belgium
Research Site, Sint-Niklaas, , Belgium
Research Site, Sao Paulo, , Brazil
Research Site, São Paulo, , Brazil
Research Site, Sofia, , Bulgaria
Research Site, Stara Zagora, , Bulgaria
Research Site, Varna, , Bulgaria
Research Site, Vratza, , Bulgaria
Research Site, Halifax, Nova Scotia, Canada
Research Site, London, Ontario, Canada
Research Site, Ottawa, Ontario, Canada
Research Site, Brno, , Czech Republic
Research Site, Jicin, , Czech Republic
Research Site, Olomouc, , Czech Republic
Research Site, Praha 2, , Czech Republic
Research Site, Praha 4 - Krc, , Czech Republic
Research Site, Praha 4, , Czech Republic
Research Site, Znojmo, , Czech Republic
Research Site, Villejuif Cedex, , France
Research Site, Budapest, , Hungary
Research Site, Debrecen, , Hungary
Research Site, Györ, , Hungary
Research Site, Szeged, , Hungary
Research Site, Lido di Camaiore, , Italy
Research Site, Modena, , Italy
Research Site, Treviglio, , Italy
Research Site, Ciudad de Panama, , 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
Name: Dr Serban Ghiorghiu
Affiliation: AstraZeneca
Role: STUDY_DIRECTOR
Name: Professor Jose Baselga
Affiliation: Vall d'Hebron University Hospital
Role: PRINCIPAL_INVESTIGATOR