Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid Tumours

NCT ID: NCT00475956

Last Updated: 2010-04-15

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-10-31

Brief Summary

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The purpose of the study is to determine if the maximum tolerated doses of AZD2171, in combination with AZD0530, in treating patients with advanced solid tumours are safe, tolerable and efficacious.

Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

AZD2171 Monotherapy

Group Type EXPERIMENTAL

AZD2171

Intervention Type DRUG

oral tablet multiple ascending doses 20, 30 or 45 mg

2

AZD2171 + AZD0530

Group Type EXPERIMENTAL

AZD2171

Intervention Type DRUG

oral tablet multiple ascending doses 20, 30 or 45 mg

AZD0530

Intervention Type DRUG

oral tablet multiple ascending doses 125 mg or 175 mg

Interventions

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AZD2171

oral tablet multiple ascending doses 20, 30 or 45 mg

Intervention Type DRUG

AZD0530

oral tablet multiple ascending doses 125 mg or 175 mg

Intervention Type DRUG

Other Intervention Names

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cediranib RECENTIN™

Eligibility Criteria

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Inclusion Criteria

* Written consent
* Cancer diagnosis \& stage
* Patients for whom no standard therapy exists
* World Health Organization (WHO) performance status 0-2
* One or more measurable lesions

Exclusion Criteria

* Prostate cancer
* Untreated unstable brain or meningeal metastases
* Specific laboratory ranges
* Pregnant or breast-feeding women
* Any evidence of severe or uncontrolled diseases
* Participation in other trials within 30 days
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

Principal Investigators

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Jane Roberston

Role: STUDY_DIRECTOR

AstraZeneca

Tanja Trarbach, MD

Role: PRINCIPAL_INVESTIGATOR

Universitatsklinikum der GHS Essen

Locations

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Research Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Research Site

Essen, Ruhr, Germany

Site Status

Research Site

Herne, Ruhr, Germany

Site Status

Countries

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Germany

Other Identifiers

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EuDract #2006-003505-55

Identifier Type: -

Identifier Source: secondary_id

D8480C00014

Identifier Type: -

Identifier Source: org_study_id

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