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

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

ChemIDplus related topics:

Cediranib Lomustine Ketoconazole

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, RECENTIN™] Monotherapy and the Combination of Cediranib With Lomustine to the Efficacy ), 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:	October 2009
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 Clinical Study, Information	800-236-9933	information.center@astrazeneca.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:	Dr. Nick Botwood, BSc, MBBS, MRCP, MFPM	AstraZeneca Aderley Park

Principal Investigator:	Dr U Lassen, MD PhD	The Finsen Center, Copenhagen, Denmark

More Information

Responsible Party:	AstraZeneca ( Dr Nick Botwood BSc, MBBS, MRCP, MFPM , Medical Science Director, RECENTIN )
Study ID Numbers:	D8480C00020, EUDRACT number 2008-002271-27
First Received:	September 8, 2008
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00750425
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

Lomustine

Tioconazole

Ketoconazole

Additional relevant MeSH terms:

Anti-Infective Agents

Therapeutic Uses

Antifungal Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008

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