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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Cediranib

Criteria

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