Phase 1 Study of the Effect of Ketoconazole on the PK of Multiple Doses of Cediranib in Patients With Solid Tumours
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Advanced Solid Tumors
Intervention: cediranib (RECENTIN TM, AZD2171) (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Jane Roberston, Study Director, Affiliation: AstraZeneca Aderley Park
Dr U Lassen, MD PhD, Principal Investigator, Affiliation: The Finsen Center, Copenhagen, Denmark
Overall contact:
AstraZeneca Clinical Study, Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
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.
Clinical Details
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 design: Treatment, Open Label, Single Group Assignment, Pharmacokinetics Study
Primary outcome: To assess the steady-state PK parameters of cediranib in the presence and absence of ketoconazole.
Secondary outcome: Safety and tolerability of cediranib in the presence of ketoconazole by assessment of Adverse events (AEs) Laboratory findings,Vital signs, physical examination and Electrocardiogram.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
AstraZeneca Clinical Study, Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
Research Site, Vancouver, Canada; Recruiting
Research Site, Hamilton, Canada; Recruiting
Research Site, Toronto, Canada; Recruiting
Research Site, Herlev, Denmark; Recruiting
Research Site, Kobenhavn, Denmark; Recruiting
Additional Information
Starting date: August 2008
Ending date: October 2009
Last updated: February 9, 2009
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