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

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: cediranib (RECENTIN TM, AZD2171)

• Registration Number: NCT00750425
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-08
• Study First Submitted QC: 2008-09-09
• Study First Posted: 2008-09-10
• Primary Completion: 2009-04
• Study Completion: 2011-01
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-09
• Last Update Posted: 2011-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	cediranib (RECENTIN TM, AZD2171)	Cediranib alone, followed by cediranib plus ketoconazole, followed by cediranib alone

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇩🇰 Kobenhavn, Denmark