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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00621725

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancer Hepatic Impairment	Drug: AZD2171	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: AZD2171 Oral dose Other Names: Cediranib

Arm

Intervention/Treatment

Experimental: 1

Drug: AZD2171

Oral dose

Other Names:

Cediranib

Outcome Measures

Primary Outcome Measures

To assess the single dose pharmacokinetics (PK) of Cediranib, in patients with cancer with various degrees of hepatic dysfunction (defined by bilirubin levels). [Single dose PK assessed on Day 1 of dosing]

Secondary Outcome Measures

Safety/tolerability of Cediranib (single and multiple dose PK) [assessed from randomisation to data cut-off (15th July 2010)]
Single and multiple dose PK assessed on Day 1 of the single dosing period and Day 21 of the multiple dosing period, respectively (minimum 7 day washout following single dosing)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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