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

Phase 2

Completed

• Conditions: Cancer
• Interventions: Drug: Cediranib; Drug: Cediranib 30 - 90 mg

• Registration Number: NCT00306891
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-03-23
• Study First Submitted QC: 2006-03-23
• Study First Posted: 2006-03-27
• Study Start: 2006-06
• Primary Completion: 2008-01
• Study Completion: 2008-09
• Disposition First Submitted: 2011-04-06
• Disposition First Submitted QC: 2011-04-06
• Disposition First Posted: 2011-04-12
• Results First Submitted: 2012-04-03
• Status Verified: 2012-10
• Results First Submitted QC: 2012-10-03
• Last Update Submitted: 2012-10-03
• Results First Posted: 2012-11-01
• Last Update Posted: 2012-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cediranib 45 mg Fasted	Cediranib	Part A: Cediranib 45 mg Fasted State
Cediranib 45 mg Fixed Dose	Cediranib	Part B: Cediranib 45 mg Fixed Dose
Cediranib 30 - 90 mg Dose Escalation	Cediranib 30 - 90 mg	Part B: Cediranib 30 - 90 mg Dose Escalation
Cediranib 45 mg Fed	Cediranib	Part A: Cediranib 45 mg Fed State

Primary Outcome Measures

Name	Time	Method
Part A: Area Under Plasma Concentration-time Curve (AUC)	Measurements were collected up to 168 hours (following single dosing).	Area under plasma concentration-time curve from zero to infinity
Part A: Maximum Plasma (Peak) Concentration (Cmax)	Measurements were collected up to 168 hours (following single dosing).	Maximum plasma drug concentration

Secondary Outcome Measures

Name	Time	Method
Part A: AUC (0-t)	Measurements were collected up to 168 hours (following single dosing).	Area under the curve from time 0 to the last measureable time point
Part A: Time to Peak or Maximum Concentration (Tmax)	Measurements were collected up to 168 hours (following single dosing).	Time to reach peak or maximum concentration or maximum response
Part A: Terminal Phase Half-life (t1/2λz)	Measurements were collected up to 168 hours (following single dosing).	Terminal phase half-life
Part A: Apparent Total Body Clearance (CL/F)	Measurements were collected up to 168 hours (following single dosing).	Apparent total body clearance of drug from plasma
Part B: Best Overall Response Rate (ORR)	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
Part B: Progression-free Survival (PFS)	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.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Manchester, United Kingdom