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
18 Years
N/A
Both
Neoplasms, Breast Neoplasms, Breast Cancer
Trial Information
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
Inclusion Criteria:
- 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 Criteria:
- 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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Phase I: To investigate the maximum tolerated dose of AZD8931 in combination with weekly paclitaxel
Outcome Time Frame:
Weekly visits for routine safety monitoring
Safety Issue:
No
Principal Investigator
Dr Serban Ghiorghiu
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
D0102C00003
NCT ID:
NCT00900627
Start Date:
June 2009
Completion Date:
March 2013
Related Keywords:
- Neoplasms
- Breast Neoplasms
- Breast Cancer
- Cancer
- Tumour
- Breast cancer
- Metastatic
- Secondary
- Breast Neoplasms
- Neoplasms
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