Phase I Study in Patients With Solid Tumours

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: Paclitaxel; Drug: Carboplatin; Drug: AZD0530

Study type: Interventional

Funder types: Industry

Identifiers

NCT00496028

AZD0530 study 23

D8180C00023

Details and patient eligibility

About

This study will comprise 2 parts, a dose escalation phase and a dose expansion phase. The 2 phases are part of a single study and described by this single protocol. Patients entered into the dose escalation phase will not be entered into the expansion phase. All subjects must be suitable for treatment with either carboplatin and/or paclitaxel.

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Life expectancy > 12 weeks
• Women defined as post-menopausal
• Male or female patients with locally advanced or metastatic cancer suitable for treatment with carboplatin and/or paclitaxel

Exclusion criteria

• Inadequate bone marrow reserve
• Inadequate live function, renal function or low haemoglobin
• Unresolved toxicity from anti-cancer therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 3 patient groups

1

Experimental group

Description:

AZD0530 + Paclitaxel

Treatment:

Drug: Paclitaxel

Drug: AZD0530

2

Experimental group

Description:

AZD0530 + Carboplatin

Treatment:

Drug: AZD0530

Drug: Carboplatin

3

Experimental group

Description:

AZD0530 + Carboplatin + Paclitaxel

Treatment:

Drug: Paclitaxel

Drug: AZD0530

Drug: Carboplatin