Antineoplastic Agents

All Drugs and Chemicals

Cediranib

Protein Kinase Inhibitors

Enzyme Inhibitors

Part B: Cediranib 30 - 90 mg Dose Escalation

Cediranib 30 - 90 mg

AstraZeneca AZD2171 Medical Science Director, MD

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.

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

Area under plasma concentration-time curve from zero to infinity

Area under the curve from time 0 to the last measureable time point

Time to reach peak or maximum concentration or maximum response

Apparent total body clearance of drug from plasma

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

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.

AstraZeneca

Cediranib 45 mg Part A

Cediranib 45 mg Fixed Dose

Cediranib 30 - 90 mg Dose Escalation

Cediranib 45 mg Fed

Cediranib 45 mg Fasted

Cediranib 30 to 90 mg Dose Escalation

Total

Age Continuous

Female, Part A

Male, Part A

Female, Part B

Male, Part B

Sex/Gender, Customized

Gerard Lynch

Part A: Area Under Plasma Concentration-time Curve (AUC)

Arm 1 - Cediranib 45 mg Fed

Arm 2 - Cediranib 45 mg Fasted

Part A: Maximum Plasma (Peak) Concentration (Cmax)

Part A: AUC (0-t)

Part A: Time to Peak or Maximum Concentration (Tmax)

Part A: Terminal Phase Half-life (t1/2λz)

Part A: Apparent Total Body Clearance (CL/F)

Arm 3 - Cediranib 45 mg Fixed Dose

Part B: Cediranib 30-90 mg Dose Escalation

Arm 4 - Cediranib 30-90 mg Dose Escalation

ITT (intention-to-treat ) patients with baseline RECIST data

Part B: Best Overall Response Rate (ORR)

ITT (intention-to-treat ) patients with baseline RECIST data.One patient was randomized and had baseline RECIST assessments, but did not have any further RECIST assessments. Therefore they were censored at baseline, meaning the lowest value in the range was set to zero.

Spots Global Cancer Trial Database for Effect of Food Upon Pharmacokinetics of Single Oral Dose of Cediranib (AZD2171, Recentin™)

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