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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00750425

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

9.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

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.]

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. [Until study drug is discountinued]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.