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

Study drug

AZD8931, Paclitaxel

Sex

All

Actual Enrollment

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

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Osaka, Japan

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

Documents available

D0102C00010 Clinical Synospis Report
Download
Reducted Protocol
Download
Clinical Study Protocol Redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Mary Stuart

AstraZeneca