Phase 1 Study of the Effect of Ketoconazole on the PK of Multiple Doses of Cediranib in Patients With Solid Tumours - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00750425

Purpose

Phase I, open study to assess the effect of ketoconazole, a marketed drug, on the way the body handles the experimental drug cediranib, in patients with advanced cancer.

Condition	Intervention	Phase
Advanced Solid Tumors	Drug: cediranib (RECENTIN TM, AZD2171)	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I, Open Label, Non-Randomised Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Multiple Oral Doses of Cediranib (AZD2171, RECENTINÔ), in Patients With Advanced Solid Tumours

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Ketoconazole

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To assess the steady-state PK parameters of cediranib in the presence and absence of ketoconazole. [ Time Frame: PK assessments to be taken until Day 42. Days 7 and 10 PK parameters used to assess the primary variables. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of cediranib in the presence of ketoconazole by assessment of Adverse events (AEs) Laboratory findings,Vital signs, physical examination and Electrocardiogram. [ Time Frame: Until study drug is discountinued ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	46
Study Start Date:	August 2008
Study Completion Date:	January 2011
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Cediranib alone, followed by cediranib plus ketoconazole, followed by cediranib alone	Drug: cediranib (RECENTIN TM, AZD2171) 20 mg cediranib once daily from Days 1 to 7; then 20 mg cediranib plus 400 mg ketoconazole from Days 8-10; then 20 mg cediranib once daily from Days 11-23. At Day 24 patients may dose escalate to 30 mg tablet once daily providing the treatment is well tolerated (this may be escalated up to 45 mg if the 30mg dose is tolerated for a minimum of 14 days)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Written informed consent
Histological or cytological confirmation of advanced solid tumour (with the exception of prostate cancer), which is refractory to standard therapies or for which no standard therapy exists.
Estimated life expectancy of at least 8 weeks
WHO performance status (PS) 0-2.

Exclusion Criteria:

Unstable brain/meningeal metastases
Biochemistry/haematology results outside of required ranges
History of significant GI impairment
Inadequate bone marrow reserve

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750425

Locations

Canada
Research Site
Hamilton, Canada
Research Site
Toronto, Canada
Research Site
Vancouver, Canada
Denmark
Research Site
Herlev, Denmark
Research Site
Kobenhavn, Denmark

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Jane Roberston	AstraZeneca Aderley Park
Principal Investigator:	Dr U Lassen, MD PhD	The Finsen Center, Copenhagen, Denmark

More Information

Additional Information:

Cancer Study Locator (US and Canada only) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Jane Robertson, Medical Science Director, RECENTIN, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00750425 History of Changes
Other Study ID Numbers:	D8480C00020, EUDRACT number 2008-002271-27
Study First Received:	September 8, 2008
Last Updated:	March 9, 2011
Health Authority:	Denmark: Danish Medicines Agency Canada: Health Canada

Keywords provided by AstraZeneca:

advanced cancer,
metastatic
ketoconazole
pharmacokinetics
Phase I

Additional relevant MeSH terms:

Neoplasms
Ketoconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 24, 2012