Phase 1 Study of the Effect of Ketoconazole on the PK of Multiple Doses of Cediranib in Patients With Solid Tumours
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00750425
First received: September 8, 2008
Last updated: March 9, 2011
Last verified: March 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors |
Drug: cediranib (RECENTIN TM, AZD2171) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
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. [ Time Frame: Until study drug is discountinued ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 46 |
| Study Start Date: | August 2008 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00750425
Locations
| Canada | |
| Research Site | |
| Hamilton, Canada | |
| Research Site | |
| Toronto, Canada | |
| Research Site | |
| Vancouver, Canada | |
| Denmark | |
| Research Site | |
| Herlev, Denmark | |
| Research Site | |
| Kobenhavn, Denmark | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Jane Roberston | AstraZeneca Aderley Park |
| Principal Investigator: | Dr U Lassen, MD PhD | The Finsen Center, Copenhagen, Denmark |
More Information
No publications provided
| Responsible Party: | Jane Robertson, Medical Science Director, RECENTIN, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00750425 History of Changes |
| Other Study ID Numbers: | D8480C00020, EUDRACT number 2008-002271-27 |
| Study First Received: | September 8, 2008 |
| Last Updated: | March 9, 2011 |
| Health Authority: | Denmark: Danish Medicines Agency Canada: Health Canada |
Keywords provided by AstraZeneca:
|
advanced cancer, metastatic ketoconazole pharmacokinetics Phase I |
Additional relevant MeSH terms:
|
Neoplasms Ketoconazole 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antifungal Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013