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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00621725 |
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 |
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 |
Estimated Enrollment: | 40 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: AZD2171
Oral dose
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: AstraZeneca Clinical Study Information | 800-236-9933 | information.center@astrazeneca.com |
Contact: AZD2171 Clinical Trials Enquiries Mailbox | AZD2171Trials@astrazeneca.com |
Denmark | |
Research Site | Recruiting |
Copenhagen, Denmark | |
Netherlands | |
Research Site | Recruiting |
Nijmegen, Netherlands | |
Research Site | Recruiting |
Rotterdam, Netherlands |
Principal Investigator: | CML van Herpen, MD | Radboud University |
Responsible Party: | AstraZeneca ( Nick Botwood / Medical Science Director ) |
Study ID Numbers: | D8480C00032, EUDRACT number 2007-005145-38 |
Study First Received: | February 13, 2008 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00621725 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Denmark: Danish Medicines Agency |
Advanced cancer metastatic hepatic impairment |
Liver Diseases Digestive System Diseases |