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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00750425
Recruitment Status : Completed
First Posted : September 10, 2008
Last Update Posted : March 10, 2011
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: cediranib (RECENTIN TM, AZD2171) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00750425

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Research Site
Hamilton, Canada
Research Site
Toronto, Canada
Research Site
Vancouver, Canada
Research Site
Herlev, Denmark
Research Site
Kobenhavn, Denmark
Sponsors and Collaborators
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Study Director: Jane Roberston AstraZeneca Aderley Park
Principal Investigator: Dr U Lassen, MD PhD The Finsen Center, Copenhagen, Denmark
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Responsible Party: Jane Robertson, Medical Science Director, RECENTIN, AstraZeneca Identifier: NCT00750425    
Other Study ID Numbers: D8480C00020
EUDRACT number 2008-002271-27
First Posted: September 10, 2008    Key Record Dates
Last Update Posted: March 10, 2011
Last Verified: March 2011
Keywords provided by AstraZeneca:
advanced cancer,
Phase I
Additional relevant MeSH terms:
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Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action