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Effect of Food Upon Pharmacokinetics of Single Oral Dose of Cediranib (AZD2171, Recentin™)

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.
 
ClinicalTrials.gov Identifier: NCT00306891
Recruitment Status : Completed
First Posted : March 27, 2006
Results First Posted : November 1, 2012
Last Update Posted : November 1, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
The purpose of this study is to determine whether food has any effect on a single dose of Cediranib (AZD2171, Recentin™)followed by an assessment of the safety and tolerability of fixed daily dosing in comparison to varying dose levels on a patient-by-patient basis.

Condition or disease Intervention/treatment Phase
Cancer Drug: Cediranib Drug: Cediranib 30 - 90 mg Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Randomised, Phase 2 Study in Patients With Advanced Solid Tumours to Determine Effect of Food Upon Pharmacokinetics of a Single Oral Dose of Cediranib (AZD2171, Recentin™), Followed by an Assessment of the Safety & Tolerability of Fixed and Individualised Daily Dosing
Study Start Date : June 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : September 2008
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cediranib 45 mg Fed
Part A: Cediranib 45 mg Fed State
 Drug: Cediranib
45 mg oral dose
Other Name: RECENTIN™
Experimental: Cediranib 45 mg Fasted
Part A: Cediranib 45 mg Fasted State
 Drug: Cediranib
45 mg oral dose
Other Name: RECENTIN™
Experimental: Cediranib 45 mg Fixed Dose
Part B: Cediranib 45 mg Fixed Dose
 Drug: Cediranib
45 mg oral dose
Other Name: RECENTIN™
Experimental: Cediranib 30 - 90 mg Dose Escalation
Part B: Cediranib 30 - 90 mg Dose Escalation
 Drug: Cediranib 30 - 90 mg
oral tablet dose escalation
Other Name: RECENTIN™


Outcome Measures
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Primary Outcome Measures :
  1. Part A: Area Under Plasma Concentration-time Curve (AUC) [ Time Frame: Measurements were collected up to 168 hours (following single dosing). ]
    Area under plasma concentration-time curve from zero to infinity

  2. Part A: Maximum Plasma (Peak) Concentration (Cmax) [ Time Frame: Measurements were collected up to 168 hours (following single dosing). ]
    Maximum plasma drug concentration


Secondary Outcome Measures :
  1. Part A: AUC (0-t) [ Time Frame: Measurements were collected up to 168 hours (following single dosing). ]
    Area under the curve from time 0 to the last measureable time point

  2. Part A: Time to Peak or Maximum Concentration (Tmax) [ Time Frame: Measurements were collected up to 168 hours (following single dosing). ]
    Time to reach peak or maximum concentration or maximum response

  3. Part A: Terminal Phase Half-life (t1/2λz) [ Time Frame: Measurements were collected up to 168 hours (following single dosing). ]
    Terminal phase half-life

  4. Part A: Apparent Total Body Clearance (CL/F) [ Time Frame: Measurements were collected up to 168 hours (following single dosing). ]
    Apparent total body clearance of drug from plasma

  5. Part B: Best Overall Response Rate (ORR) [ Time Frame: Baseline, week 8, week 16 and every 8 weeks thereafter until discontinuation. ]

    Evaluation of target lesions Complete Response(CR)Disappearance of all target lesions Partial Response(PR) At least a 30% decrease in the sum of LD(longest diameter)of target lesions taking as reference the baseline sum LD.Progressive Disease(PD).At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded(either at baseline or at previous assessment since treatment began).Stable Disease(SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.Note: Appearance of new lesions only counts towards the overall visit response,not towards the response of target or non-target lesions.

    Evaluation of non-target lesions Complete Response(CR)Disappearance of all non-target lesions Non-Complete Response(non-CR/Non-Progression[non-PD])Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits.Progression(PD)Unequivocal progression of existing non-target lesions


  6. Part B: Progression-free Survival (PFS) [ Time Frame: Number of days from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression. ]

    Target lesions: Progressive Disease (PD) At least a 20% increase in the sum of LD (longest diameter)of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).

    Non target lesions: Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits.

    Progression (PD) Unequivocal progression of existing non-target lesions.



Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • Clinical diagnosis of advanced solid tumour.
  • Ability to eat a high fat breakfast

Exclusion Criteria:

  • Poorly controlled high blood pressure.
  • History of significant gastrointestinal problems
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00306891


Locations
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United Kingdom
Research Site
Glasgow, United Kingdom
Research Site
Headington, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca AZD2171 Medical Science Director, MD AstraZeneca
More Information
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Additional Information:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00306891    
Other Study ID Numbers: D8480C00021
2005-003441-13
First Posted: March 27, 2006    Key Record Dates
Results First Posted: November 1, 2012
Last Update Posted: November 1, 2012
Last Verified: October 2012
Keywords provided by AstraZeneca:
Advanced solid tumours
Advanced cancer
tumor
tumour
RECENTIN
Additional relevant MeSH terms:
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Cediranib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action