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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment; Advanced Cancer

Treatments: Drug: AZD2171

Study type: Interventional

Funder types: Industry

Identifiers

NCT00621725

D8480C00032

EUDRACT number 2007-005145-38

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 1 patient group

1

Experimental group

Treatment:

Drug: AZD2171