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Phase I Study in Patients With Solid Tumours

NCT ID: NCT00496028

Last Updated: 2010-09-22

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

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

AZD0530 + Paclitaxel

Group Type EXPERIMENTAL

AZD0530

Intervention Type DRUG

oral tablet

Paclitaxel

Intervention Type DRUG

intravenous infusion

2

AZD0530 + Carboplatin

Group Type EXPERIMENTAL

AZD0530

Intervention Type DRUG

oral tablet

Carboplatin

Intervention Type DRUG

intravenous infusion

3

AZD0530 + Carboplatin + Paclitaxel

Group Type EXPERIMENTAL

AZD0530

Intervention Type DRUG

oral tablet

Carboplatin

Intervention Type DRUG

intravenous infusion

Paclitaxel

Intervention Type DRUG

intravenous infusion

Interventions

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AZD0530

oral tablet

Intervention Type DRUG

Carboplatin

intravenous infusion

Intervention Type DRUG

Paclitaxel

intravenous infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Steinar Aamdal, MD

Role: PRINCIPAL_INVESTIGATOR

Radium Hospital, Norway

Mary Stuart, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Paris, , France

Site Status

Research Site

Pierre-Bénite, , France

Site Status

Research Site

Amsterdam, , Netherlands

Site Status

Research Site

Groningen, , Netherlands

Site Status

Research Site

Oslo, , Norway

Site Status

Research Site

Glasgow, , United Kingdom

Site Status

Research Site

Sutton, , United Kingdom

Site Status

Countries

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France Netherlands Norway United Kingdom

Other Identifiers

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AZD0530 study 23

Identifier Type: -

Identifier Source: secondary_id

D8180C00023

Identifier Type: -

Identifier Source: org_study_id