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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Drug: Cediranib; Drug: Cediranib 30 - 90 mg

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
    • Research Site
  • Headington, United Kingdom
    • Research Site
  • London, United Kingdom
    • Research Site
  • Manchester, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cediranib 45 mg Fed; Part A: Cediranib 45 mg Fed State	Drug: Cediranib; 45 mg oral dose; Other Names: RECENTIN™
Experimental: Cediranib 45 mg Fasted; Part A: Cediranib 45 mg Fasted State	Drug: Cediranib; 45 mg oral dose; Other Names: RECENTIN™
Experimental: Cediranib 45 mg Fixed Dose; Part B: Cediranib 45 mg Fixed Dose	Drug: Cediranib; 45 mg oral dose; Other Names: 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 Names: RECENTIN™

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: AstraZeneca AZD2171 Medical Science Director, MD, AstraZeneca

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: March 23, 2006
• First Submitted That Met QC Criteria: March 23, 2006
• First Posted (Estimate): March 27, 2006

Study Record Updates

• Last Update Posted (Estimate): November 1, 2012
• Last Update Submitted That Met QC Criteria: October 3, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: tumour; Advanced cancer; Advanced solid tumours; tumor; RECENTIN
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Cediranib
• Other Study ID Numbers: D8480C00021; 2005-003441-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No