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Study to Investigate the Management of Hypertension and Efficacy of AZD2171 in Patients With Advanced Solid Tumours

NCT ID: NCT00264004

Last Updated: 2012-08-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2011-04-30

Brief Summary

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The purpose of this study is to determine whether doses of 30 mg and 45 mg AZD2171 can be well tolerated without significant drug withdrawal when accompanied by a suitable hypertension management strategy or dose reduction.

Detailed Description

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Conditions

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Tumors

Keywords

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Advanced Solid Tumours phase II Hypertension RECENTIN

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

30 mg AZD2171

Group Type EXPERIMENTAL

AZD2171

Intervention Type DRUG

30 mg \& 45 mg oral tablet

2

45 mg AZD2171

Group Type EXPERIMENTAL

AZD2171

Intervention Type DRUG

30 mg \& 45 mg oral tablet

Interventions

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AZD2171

30 mg \& 45 mg oral tablet

Intervention Type DRUG

Other Intervention Names

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Cediranib RECENTIN™

Eligibility Criteria

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Inclusion Criteria

* Histological or cytological confirmation of advanced solid tumour, which is refractory to standard therapies or for which no standard therapy exists and for which there is a rationale for the therapeutic use of a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor.

Exclusion Criteria

* Prior treatment with a VEGF inhibitor
* Poorly controlled hypertension
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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Responsibility Role SPONSOR

Principal Investigators

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Jane Robertson, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Freiburg im Breisgau, , Germany

Site Status

Research Site

Hamburg, , Germany

Site Status

Research Site

Amsterdam, , Netherlands

Site Status

Research Site

Nijmegen, , Netherlands

Site Status

Research Site

Utrecht, , Netherlands

Site Status

Research Site

Surrey, , United Kingdom

Site Status

Countries

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Germany Netherlands United Kingdom

Other Identifiers

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EUDRACT Number 2005-003442-33

Identifier Type: -

Identifier Source: secondary_id

D8480C00038

Identifier Type: -

Identifier Source: org_study_id