A Study to Determine the Pharmacokinetics of Cediranib in Chinese Patients With Advanced Solid Malignancies

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-04-30

Brief Summary

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This study is being carried out to see how single and multiple doses of cediranib are handled by the body (that is how they are absorbed, broken down and got rid of from the body) by measuring levels of drug in the blood in Chinese patients with advanced solid malignancies.

The study will also assess the tolerability of 20 or 30 mg cediranib in Chinese patients and how the tumour responds to treatment with cediranib.

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Detailed Description

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Conditions

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Advanced Solid Malignancies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

cediranib 20mg

Group Type EXPERIMENTAL

cediranib (RECENTIN TM, AZD2171)

Intervention Type DRUG

20 mg or 30mg cediranib once on Days 1, then 20 mg or 30mg cediranib once daily from Days 8

2

cediranib 30mg

Group Type EXPERIMENTAL

cediranib (RECENTIN TM, AZD2171)

Intervention Type DRUG

20 mg or 30mg cediranib once on Days 1, then 20 mg or 30mg cediranib once daily from Days 8

Interventions

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cediranib (RECENTIN TM, AZD2171)

20 mg or 30mg cediranib once on Days 1, then 20 mg or 30mg cediranib once daily from Days 8

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent
* Histological and/or cytological confirmed advanced solid malignancies
* Refractory to conventional therapeutic modalities, or for which no appropriate therapies exist

Exclusion Criteria

* For the first question: Patients with a history of poorly controlled hypertension with resting blood pressure \>150/100 mmHg in the presence or absence of a stable regimen of antihypertensive therapy, or patients who are requiring maximal doses of calcium channel blockers to stabilize blood pressure.
* Significant haemorrhage (\>30 ml/bleeding episode in previous 3 months), haemoptysis (\>5 ml fresh blood in previous 4 weeks) or thrombotic event (including transient ischaemic attack) in the previous 12 months
* Recent(\<28 days) major thoracic and abdominal surgery prior to entry into the study, or a surgical incision that is not fully healed.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No