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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Metastatic Cancer; Breast Cancer; Neoplasms

Treatments: Drug: Paclitaxel; Drug: AZD8931

Study type: Interventional

Funder types: Industry

Identifiers

NCT01003158

D0102C00010

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Inadequate kidney, liver, heart, gastric, lung or eye function
• Brain metastases
• Hypersensitive to paclitaxel (combination part)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Monotherapy part

Experimental group

Description:

AZD8931 monotherapy

Treatment:

Drug: AZD8931

Combination part

Experimental group

Description:

AZD8931 plus paclitaxel

Treatment:

Drug: AZD8931

Drug: Paclitaxel