Spots Global Cancer Trial Database for Phase I/II Study of AZD2281 Given in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer
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Trial Identification
Brief Title: Phase I/II Study of AZD2281 Given in Combination With Paclitaxel in Metastatic Triple Negative Breast Cancer
Official Title: Phase I/II Randomised, Double- Blind, Multi-centre Study to Assess the Efficacy of AZD2281 When Given in Combination With Paclitaxel in the 1st or 2nd Line Treatment of Patients With Metastatic Triple Negative Breast Cancer.
Study ID: NCT00707707
Study Description
Brief Summary: This is the first part of a 2-part study assessing the efficacy of AZD2281 in combination with paclitaxel in 1st or 2nd line treatment of patients with metastatic triple negative breast cancer. This first part (Phase I) is an open-label, intra patient dose finding study to establish the appropriate doses and schedule of paclitaxel and AZD2281 in combination, to be used in the randomized Phase II part. The safety and tolerability of AZD2281 in combination with paclitaxel will be explored. Approximately 10 patients per cohort from 4-5 countries will be enrolled in Phase I.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Research Site, Auchenflower, , Australia
Research Site, Parkville, , Australia
Research Site, Perth, , Australia
Research Site, Wien, , Austria
Research Site, Leuven, , Belgium
Research Site, Toronto, Ontario, Canada
Contact Details
Name: Rebecca Dent, MD
Affiliation: Sunnybrook Health Sciences Centre, Toronto
Role: PRINCIPAL_INVESTIGATOR
Name: Mark Clemons, MD
Affiliation: Princess Margaret Hospital, Toronto
Role: PRINCIPAL_INVESTIGATOR
Name: Mika Sovak, MD PhD
Affiliation: AstraZeneca
Role: STUDY_DIRECTOR
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