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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00306891
First received: March 23, 2006
Last updated: October 3, 2012
Last verified: October 2012

March 23, 2006
October 3, 2012
June 2006
January 2008   (final data collection date for primary outcome measure)
  • Part A: Area Under Plasma Concentration-time Curve (AUC) [ Time Frame: Measurements were collected up to 168 hours (following single dosing). ] [ Designated as safety issue: No ]
    Area under plasma concentration-time curve from zero to infinity
  • Part A: Maximum Plasma (Peak) Concentration (Cmax) [ Time Frame: Measurements were collected up to 168 hours (following single dosing). ] [ Designated as safety issue: No ]
    Maximum plasma drug concentration
To compare the pharmacokinetic (PK) parameters of AZD2171 following single oral dose of 45 mg to patients in the fed and fasted state.
Complete list of historical versions of study NCT00306891 on ClinicalTrials.gov Archive Site
  • Part A: AUC (0-t) [ Time Frame: Measurements were collected up to 168 hours (following single dosing). ] [ Designated as safety issue: No ]
    Area under the curve from time 0 to the last measureable time point
  • Part A: Time to Peak or Maximum Concentration (Tmax) [ Time Frame: Measurements were collected up to 168 hours (following single dosing). ] [ Designated as safety issue: No ]
    Time to reach peak or maximum concentration or maximum response
  • Part A: Terminal Phase Half-life (t1/2λz) [ Time Frame: Measurements were collected up to 168 hours (following single dosing). ] [ Designated as safety issue: No ]
    Terminal phase half-life
  • Part A: Apparent Total Body Clearance (CL/F) [ Time Frame: Measurements were collected up to 168 hours (following single dosing). ] [ Designated as safety issue: No ]
    Apparent total body clearance of drug from plasma
  • Part B: Best Overall Response Rate (ORR) [ Time Frame: Baseline, week 8, week 16 and every 8 weeks thereafter until discontinuation. ] [ Designated as safety issue: No ]

    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

  • 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. ] [ Designated as safety issue: No ]

    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.

To compare safety & tolerability of AZD2171 when given as either fixed dose or via dose escalation
Not Provided
Not Provided
 
Effect of Food Upon Pharmacokinetics of Single Oral Dose of Cediranib (AZD2171, Recentin™)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
  • Drug: Cediranib
    45 mg oral dose
    Other Name: RECENTIN™
  • Drug: Cediranib 30 - 90 mg
    oral tablet dose escalation
    Other Name: RECENTIN™
  • Experimental: Cediranib 45 mg Fed
    Part A: Cediranib 45 mg Fed State
    Intervention: Drug: Cediranib
  • Experimental: Cediranib 45 mg Fasted
    Part A: Cediranib 45 mg Fasted State
    Intervention: Drug: Cediranib
  • Experimental: Cediranib 45 mg Fixed Dose
    Part B: Cediranib 45 mg Fixed Dose
    Intervention: Drug: Cediranib
  • Experimental: Cediranib 30 - 90 mg Dose Escalation
    Part B: Cediranib 30 - 90 mg Dose Escalation
    Intervention: Drug: Cediranib 30 - 90 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00306891
D8480C00021, 2005-003441-13
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: AstraZeneca AZD2171 Medical Science Director, MD AstraZeneca
AstraZeneca
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP