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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Cancer

Treatments: Drug: Cediranib 30 - 90 mg; Drug: Cediranib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00306891

D8480C00021

2005-003441-13

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Cediranib 45 mg Fed

Experimental group

Description:

Part A: Cediranib 45 mg Fed State

Treatment:

Drug: Cediranib

Cediranib 45 mg Fasted

Experimental group

Description:

Part A: Cediranib 45 mg Fasted State

Treatment:

Drug: Cediranib

Cediranib 45 mg Fixed Dose

Experimental group

Description:

Part B: Cediranib 45 mg Fixed Dose

Treatment:

Drug: Cediranib

Cediranib 30 - 90 mg Dose Escalation

Experimental group

Description:

Part B: Cediranib 30 - 90 mg Dose Escalation

Treatment:

Drug: Cediranib 30 - 90 mg