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

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750425
• Other study ID #: D8480C00020
• Secondary ID: EUDRACT number 2
• Status: Completed
• Phase: Phase 1
• First received: September 8, 2008
• Last updated: March 9, 2011
• Start date: August 2008
• Est. completion date: January 2011

Study information

• Verified date: March 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2011
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

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)

Locations

Country	Name	City	State
Canada	Research Site	Hamilton
Canada	Research Site	Toronto
Canada	Research Site	Vancouver
Denmark	Research Site	Herlev
Denmark	Research Site	Kobenhavn

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Canada,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the steady-state PK parameters of cediranib in the presence and absence of ketoconazole.		PK assessments to be taken until Day 42. Days 7 and 10 PK parameters used to assess the primary variables.	No
Secondary	Safety and tolerability of cediranib in the presence of ketoconazole by assessment of Adverse events (AEs) Laboratory findings,Vital signs, physical examination and Electrocardiogram.		Until study drug is discountinued	Yes

External Links

•   Cancer Study Locator (US and Canada only)