Study Assessing Safety and Tolerability of AZD8931 Alone or in Combination With Paclitaxel in Japanese Patients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-04-30

Brief Summary

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The main purpose of this study is to determine if AZD8931 can be safely administered in Japanese patients alone and in combination with weekly paclitaxel. The study will be conducted in two parts: a monotherapy and a combination part, where safe doses of study treatment will be determined.

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Detailed Description

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Conditions

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Neoplasms Metastatic Cancer Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Monotherapy part

AZD8931 monotherapy

Group Type EXPERIMENTAL

AZD8931

Intervention Type DRUG

Tablet Oral bid

Combination part

AZD8931 plus paclitaxel

Group Type EXPERIMENTAL

AZD8931

Intervention Type DRUG

Tablet Oral bid

Paclitaxel

Intervention Type DRUG

IV once weekly for 3 weeks followed by a week off

Interventions

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AZD8931

Tablet Oral bid

Intervention Type DRUG

Paclitaxel

IV once weekly for 3 weeks followed by a week off

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Cancer that is refractory to standard therapies, or for which no standard therapies exist (monotherapy part)
* Patients suitable for Paclitaxel chemotherapy, who are not candidates for hormonal and anthracycline therapy (combination part)
* Life expectancy more than 12 weeks