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
  Purpose

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 Intervention Phase
Cancer
Drug: Cediranib
Drug: Cediranib 30 - 90 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.



Enrollment: 60
Study Start Date: June 2006
Study Completion Date: September 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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™

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306891

Locations
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
Study Director: AstraZeneca AZD2171 Medical Science Director, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00306891     History of Changes
Other Study ID Numbers: D8480C00021, 2005-003441-13
Study First Received: March 23, 2006
Results First Received: April 3, 2012
Last Updated: October 3, 2012
Health Authority: United Kingdom: Department of Health

Keywords provided by AstraZeneca:
Advanced solid tumours
Advanced cancer
tumor
tumour
RECENTIN

Additional relevant MeSH terms:
Cediranib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014