Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Ketoconazole

Cediranib

Protein Kinase Inhibitors

Enzyme Inhibitors

Cediranib alone, followed by cediranib plus ketoconazole, followed by cediranib alone

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)

cediranib (RECENTIN TM, AZD2171)

Jane Roberston

Dr U Lassen, MD PhD

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.

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

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

AstraZeneca

Jane Robertson, Medical Science Director, RECENTIN

20 mg or 30mg cediranib once on Days 1, then 20 mg or 30mg cediranib once daily from Days 8

Jeannie Hou

Sun Yan, Prof

This study is being carried out to see how single and multiple doses of cediranib are handled by the body (that is how they are absorbed, broken down and got rid of from the body) by measuring levels of drug in the blood in Chinese patients with advanced solid malignancies.

The study will also assess the tolerability of 20 or 30 mg cediranib in Chinese patients and how the tumour responds to treatment with cediranib.

A Study to Determine the Pharmacokinetics of Cediranib in Chinese Patients With Advanced Solid Malignancies

A Phase I, Randomised, Multi-centre, Open-label Study to Determine the Pharmacokinetics and Tolerability of Cediranib (RECENTIN™, AZD2171) Following a Single and Multiple Oral 20mg or 30 mg Doses in Chinese Patients With Advanced Solid Malignancies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase 1 Study of the Effect of Ketoconazole on the PK of Multiple Doses of Cediranib in Patients With Solid Tumours	NCT00750425	Advanced Solid ...	cediranib (RECE...	18 Years -	AstraZeneca
A Study to Determine the Pharmacokinetics of Cediranib in Chinese Patients With Advanced Solid Malignancies	NCT00981721	Advanced Solid ...	cediranib (RECE...	18 Years -	AstraZeneca
Phase 1 Study of the Effect of Ketoconazole on the PK of Multiple Doses of Cediranib in Patients With Solid Tumours	NCT00750425	Advanced Solid ...	cediranib (RECE...	18 Years -	AstraZeneca

Spots Global Cancer Trial Database for cediranib (recentin tm, azd2171)