Phase 1 PK study of cediranib in single and multiple doses in hepatically impaired patients with solid tumours

Study identifier:D8480C00032

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Open Label Study of the Pharmacokinetics and Safety of cediranib (RECENTINTM, AZD2171) following Single and Multiple Oral Doses in Patients with Advanced Solid Tumours with Various Degrees of Hepatic Dysfunction

Medical condition

Advanced cancer, Hepatic Impairment

Phase

Phase 1

Healthy volunteers

No

Study drug

AZD2171

Sex

All

Actual Enrollment

36

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 01 Jan 2008
Primary Completion Date: 01 Jul 2010
Study Completion Date: 01 Jan 2014

Study design

Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2014 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria