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

Phase 1

Completed

• Conditions: Hepatic Impairment; Advanced Cancer
• Interventions: Drug: AZD2171

• Registration Number: NCT00621725
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-13
• Study First Submitted QC: 2008-02-13
• Study First Posted: 2008-02-22
• Primary Completion: 2010-07
• Study Completion: 2014-01
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-14
• Last Update Posted: 2014-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD2171	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Research Site; 🇳🇱 Rotterdam, Netherlands