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

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.

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Key information

Conditions

Advanced Solid Tumors Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Hamilton, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cediranib (RECENTIN TM, AZD2171)

Drug

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)

Primary outcomes

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.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2011
First posted: Sep 10, 2008
Registry last updated: Mar 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed