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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Part B:  Cediranib 30 - 90 mg Dose Escalation

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™)

AstraZeneca Information - Outside of the US

Research Site

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

Age Continuous

Gender, Customized

Part A: area under plasma concentration-time curve (AUC)

Part A: maximum plasma (peak) concentration (Cmax)

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

Part A: AUC (0-t)

Time to reach peak or maximum concentration or maximum response

Part A: time to peak or maximum concentration (tmax)

Part A: terminal phase half-life (t1/2λz)

Apparent total body clearance of drug from plasma

Part A: apparent total body clearance (CL/F)

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

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

Part B: best overall response rate (ORR)

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.

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.

Part B: progression-free survival (PFS)

Part A

Part B

60 patients were enrolled though only 45 patients were randomized to Part A and 47 to Part B.
Completion  of Part B means completed at least 16 weeks of treatment.

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™

Effect of food upon pharmacokinetics of single oral dose of Cediranib (AZD2171, Recentin™)

Official Title

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Verification:

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Documents available

AstraZeneca Information - Outside of the US

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=418&filename=CSR-D8480C00021.pdf

CSR-D8480C00021.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator