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

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: AZD2171; Drug: AZD0530

• Registration Number: NCT00475956
• Lead Sponsor: AstraZeneca

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-18
• Study First Submitted QC: 2007-05-18
• Study First Posted: 2007-05-21
• Primary Completion: 2008-10
• Study Completion: 2009-10
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-14
• Last Update Posted: 2010-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD2171	AZD2171 Monotherapy
2	AZD2171	AZD2171 + AZD0530
2	AZD0530	AZD2171 + AZD0530

Primary Outcome Measures

Name	Time	Method
Determine the safety and tolerability of ascending daily oral doses of AZD2171 when co-administered with AZD0530 to patients with advanced solid tumours by assessment of AEs, vital signs, HRCT Scans, clin chem, haematology, urinalysis, ECG and phys exam	assessed at each visit

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of AZD2171 alone and in combination with AZD0530	assessed at each visit
Genetic variation of pathways targeted by AZD2171 and AZD0530	assessed during study
Safety and efficacy	assessed at each visit

Trial Locations

Locations (1)

Research Site; 🇩🇪 Herne, Ruhr, Germany