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Effect of Food Upon Pharmacokinetics of Single Oral Dose of Cediranib (AZD2171, Recentin™)

NCT ID: NCT00306891

Last Updated: 2012-11-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to determine whether food has any effect on a single dose of Cediranib (AZD2171, Recentin™)followed by an assessment of the safety and tolerability of fixed daily dosing in comparison to varying dose levels on a patient-by-patient basis.

Detailed Description

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Conditions

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Cancer

Keywords

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Advanced solid tumours Advanced cancer tumor tumour RECENTIN

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cediranib 45 mg Fed

Part A: Cediranib 45 mg Fed State

Group Type EXPERIMENTAL

Cediranib

Intervention Type DRUG

45 mg oral dose

Cediranib 45 mg Fasted

Part A: Cediranib 45 mg Fasted State

Group Type EXPERIMENTAL

Cediranib

Intervention Type DRUG

45 mg oral dose

Cediranib 45 mg Fixed Dose

Part B: Cediranib 45 mg Fixed Dose

Group Type EXPERIMENTAL

Cediranib

Intervention Type DRUG

45 mg oral dose

Cediranib 30 - 90 mg Dose Escalation

Part B: Cediranib 30 - 90 mg Dose Escalation

Group Type EXPERIMENTAL

Cediranib 30 - 90 mg

Intervention Type DRUG

oral tablet dose escalation

Interventions

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Cediranib

45 mg oral dose

Intervention Type DRUG

Cediranib 30 - 90 mg

oral tablet dose escalation

Intervention Type DRUG

Other Intervention Names

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RECENTIN™ RECENTIN™

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of advanced solid tumour.
* Ability to eat a high fat breakfast

Exclusion Criteria

* Poorly controlled high blood pressure.
* History of significant gastrointestinal problems
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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AstraZeneca AZD2171 Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Glasgow, , United Kingdom

Site Status

Research Site

Headington, , United Kingdom

Site Status

Research Site

London, , United Kingdom

Site Status

Research Site

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2005-003441-13

Identifier Type: -

Identifier Source: secondary_id

D8480C00021

Identifier Type: -

Identifier Source: org_study_id