Phase I/II AZD8931/Paclitaxel in treatment of advanced solid tumours (Phase I) and advanced breast cancer (Phase II) - THYME
Study identifier:D0102C00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Neoplasms
Phase
Phase 1/2
Healthy volunteers
No
Study drug
AZD8931, Paclitaxel, Placebo
Sex
All
Actual Enrollment
330
Study type
Interventional
Age
18 Years - 150 Years
Date
Study Start Date: 01 Jun 2009
Primary Completion Date: 01 Apr 2012
Study Completion Date: 01 Feb 2015
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jun 2015 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD8931 plus Paclitaxel | Drug: AZD8931 Tablet Oral bid Drug: Paclitaxel IV once weekly for 3 weeks followed by a week off (repeated cycles) Other Name: Taxol |
| Placebo Comparator: 2 Placebo plus Paclitaxel | Drug: Paclitaxel IV once weekly for 3 weeks followed by a week off (repeated cycles) Other Name: Taxol Drug: Placebo Oral bid (twice daily) |
Contacts
Investigators
Principal Investigator
Dr Serban Ghiorghiu
AstraZeneca
