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

This study is currently recruiting participants.

Verified by AstraZeneca, April 2009

First Received: February 13, 2008 Last Updated: April 30, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00621725

Purpose

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

Condition	Intervention	Phase
Advanced Cancer Hepatic Impairment	Drug: AZD2171	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Cediranib

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
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

Further study details as provided by AstraZeneca:

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). [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety/tolerability of Cediranib; single and multiple dose PK [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AZD2171 Oral dose

Eligibility

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621725

Contacts

Contact: AstraZeneca Clinical Study Information	800-236-9933	information.center@astrazeneca.com
Contact: AZD2171 Clinical Trials Enquiries Mailbox		AZD2171Trials@astrazeneca.com

Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

CML van Herpen, MD

Radboud University

More Information

No publications provided

Responsible Party:	AstraZeneca ( Jane Robertson/ Medical Science Director )
Study ID Numbers:	D8480C00032, EUDRACT number 2007-005145-38
Study First Received:	February 13, 2008
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00621725 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Denmark: Danish Medicines Agency

Keywords provided by AstraZeneca:

Advanced cancer
metastatic
hepatic impairment

Study placed in the following topic categories:

Liver Diseases
Digestive System Diseases

Additional relevant MeSH terms:

Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 06, 2009