Phase 1 PK Study of Cediranib in Single and Multiple Doses in Hepatically Impaired Patients With Solid Tumours

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2014-01-31

Brief Summary

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To determine how patients with advanced cancer and various degrees of hepatic impairment will metabolise Cediranib.

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Detailed Description

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Conditions

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Advanced Cancer Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

AZD2171

Intervention Type DRUG

Oral dose

Interventions

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AZD2171

Oral dose

Intervention Type DRUG

Other Intervention Names

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Cediranib

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Advanced solid tumour (not prostate cancer) for which no standard therapy exists
* WHO performance status 0-2
* Bilirubin levels within the target range

Exclusion Criteria

* Unstable brain/meningeal metastases
* Inadequate bone marrow reserve
* Biochemistry/haematology results outside of required ranges
* History of significant GI impairment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No