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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00306891
• Other study ID #: D8480C00021
• Secondary ID: 2005-003441-13
• Status: Completed
• Phase: Phase 2
• First received: March 23, 2006
• Last updated: October 3, 2012
• Start date: June 2006
• Est. completion date: September 2008

Study information

• Verified date: October 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Cediranib
45 mg oral dose
• Cediranib 30 - 90 mg
oral tablet dose escalation

Locations

Country	Name	City	State
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Headington
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Area Under Plasma Concentration-time Curve (AUC)	Area under plasma concentration-time curve from zero to infinity	Measurements were collected up to 168 hours (following single dosing).	No
Primary	Part A: Maximum Plasma (Peak) Concentration (Cmax)	Maximum plasma drug concentration	Measurements were collected up to 168 hours (following single dosing).	No
Secondary	Part A: AUC (0-t)	Area under the curve from time 0 to the last measureable time point	Measurements were collected up to 168 hours (following single dosing).	No
Secondary	Part A: Time to Peak or Maximum Concentration (Tmax)	Time to reach peak or maximum concentration or maximum response	Measurements were collected up to 168 hours (following single dosing).	No
Secondary	Part A: Terminal Phase Half-life (t1/2?z)	Terminal phase half-life	Measurements were collected up to 168 hours (following single dosing).	No
Secondary	Part A: Apparent Total Body Clearance (CL/F)	Apparent total body clearance of drug from plasma	Measurements were collected up to 168 hours (following single dosing).	No
Secondary	Part B: Best Overall Response Rate (ORR)	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	Baseline, week 8, week 16 and every 8 weeks thereafter until discontinuation.	No
Secondary	Part B: Progression-free Survival (PFS)	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.	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.	No

External Links

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