Status:
COMPLETED
Phase I/II AZD8931/Paclitaxel in Treatment of Advanced Solid Tumours (Phase I) and Advanced Breast Cancer (Phase II)
Lead Sponsor:
AstraZeneca
Conditions:
Neoplasms
Breast Neoplasms
Eligibility:
All Genders
18-150 years
Phase:
PHASE1
PHASE2
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 fi...
Eligibility Criteria
Inclusion
- Male/ female with solid, malignant tumour which is unresponsive to standard therapies (Phase I). Female patients with advanced breast cancer with low HER2 expression (Phase II)
- Suitable for paclitaxel chemotherapy
- Life expectancy more than 12 weeks
Exclusion
- Inadequate kidney, liver, heart, gastric, lung or eye function
- Hypersensitive to paclitaxel
- No symptomatic uncontrolled brain metastases
- Previous taxane chemotherapy within 12 months (Phase II)
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00900627
Start Date
June 1 2009
End Date
February 1 2015
Last Update
January 20 2016
Active Locations (38)
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1
Research Site
Brussels (Jette), Belgium
2
Research Site
Leuven, Belgium
3
Research Site
Namur, Belgium
4
Research Site
Sint-Niklaas, Belgium