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

Sponsored by:	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 I

MedlinePlus related topics: Cancer

Drug Information available for: Ketoconazole Fungarest Cediranib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Pharmacokinetics Study
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

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
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

Contacts

Contact: AstraZeneca Cancer Locator Service	877-400-4656	astrazeneca@emergingmed.com
Contact: RECENTIN Enquiries Mailbox		AZD2171trials@astrazeneca.com

Locations

Canada
Research Site	Recruiting
Vancouver, Canada
Research Site	Recruiting
Hamilton, Canada
Research Site	Recruiting
Toronto, Canada
Denmark
Research Site	Recruiting
Herlev, Denmark
Research Site	Recruiting
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:

US and Canada only This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	AstraZeneca ( Jane Robertson, Medical Science Director, RECENTIN )
Study ID Numbers:	D8480C00020, EUDRACT number 2008-002271-27
Study First Received:	September 8, 2008
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00750425 History of Changes
Health Authority:	Denmark: Danish Medicines Agency; Canada: Health Canada

Keywords provided by AstraZeneca:

advanced cancer,
metastatic
ketoconazole
pharmacokinetics
Phase I

Study placed in the following topic categories:

Clotrimazole
Miconazole
Antifungal Agents
Tioconazole
Ketoconazole

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antifungal Agents
Ketoconazole
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009