Phase I/II AZD8931/Paclitaxel in Treatment of Advanced Solid Tumours (Phase I) and Advanced Breast Cancer (Phase II) (THYME)

AstraZeneca

Status and phase: Completed; Phase 2; Phase 1

Conditions: Breast Cancer; Neoplasms; Breast Neoplasms

Treatments: Drug: Placebo; Drug: Paclitaxel; Drug: AZD8931

Study type: Interventional

Funder types: Industry

Identifiers

NCT00900627

D0102C00003

Details and patient eligibility

About

The main purpose of this study is to determine if AZD8931 can improve the efficacy of standard chemotherapy for the treatment of advanced breast cancer. This study will be conducted in 2 parts: the first part (phase I) will determine a dose of AZD8931 that can be safely administered with paclitaxel chemotherapy. The second part (phase II) will determine the efficacy and safety of AZD8931 in combination with paclitaxel chemotherapy in breast cancer.

Enrollment: 330 patients

Sex: All

Ages: 18 to 150 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male/ female with solid, malignant tumour which is unresponsive to standard therapies (Phase I). Female patients with advanced breast cancer with low HER2 expression (Phase II)
• Suitable for paclitaxel chemotherapy
• Life expectancy more than 12 weeks

Exclusion criteria

• Inadequate kidney, liver, heart, gastric, lung or eye function
• Hypersensitive to paclitaxel
• No symptomatic uncontrolled brain metastases
• Previous taxane chemotherapy within 12 months (Phase II)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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330 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

AZD8931 plus Paclitaxel

Treatment:

Drug: Paclitaxel

Drug: AZD8931

2

Placebo Comparator group

Description:

Placebo plus Paclitaxel

Treatment:

Drug: Placebo

Drug: Paclitaxel