Study Assessing Safety and Tolerability of AZD8931 alone or in combination with paclitaxel in Japanese patients.
Study identifier:D0102C00010
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Open-label, Multiple-dose, Dose-escalation Study To Assess the Safety and Tolerability of AZD8931 Monotherapy in Japanese Patients with Advanced Solid Malignancies and in Combination with Paclitaxel in Japanese Female Patients with Advanced Breast Cancer
Medical condition
Neoplasms
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD8931, Paclitaxel
Sex
All
Actual Enrollment
17
Study type
Interventional
Age
20 Years +
Date
Study Start Date: 01 Oct 2009
Primary Completion Date: 01 Apr 2012
Study Completion Date: 01 Apr 2012
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Monotherapy part AZD8931 monotherapy | Drug: AZD8931 Tablet Oral bid |
| Experimental: Combination part AZD8931 plus paclitaxel | Drug: AZD8931 Tablet Oral bid Drug: Paclitaxel IV once weekly for 3 weeks followed by a week off |
Contacts
Investigators
Principal Investigator
Mary Stuart
AstraZeneca
