EU Clinical Trial Information System (CTIS)

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

Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours and also how well it is tolerated.

Cediranib (AZD2171, RECENTIN™) in Metastatic or Recurrent Renal Cell Carcinoma

Research Site

A Phase II, Randomised, Double-blind, Parallel Group Study to Assess the Efficacy of Cediranib 45mg Versus Placebo following 12 Weeks of Treatment in Patients with Metastatic or Recurrent Renal Cell Carcinoma who have had no Previous Anti-VEGF Therapy.

Age Continuous

Gender, Male/Female

Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)*100

For patients to be included in the analysis they had to have been evaluable for RECIST with week 12 or progression tumour size data

Percentage change from baseline in tumour size at 12 weeks

Maximum reduction or minimum increase in tumour size where size is the sum of the longest diameters of the target lesions

For patients to be included in the analysis they had to have been evaluable for RECIST with week 12 or progression tumour size data.

Best percentage change from baseline in tumour size during the study

Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for complete response (CR)/partial response (PR) are first met (whichever is recorded first) until the patient progresses or dies.

For patients to be included in the analysis they had to have been evaluable for RECIST and have been a responder (Complete response (CR) or Partial Response (PR)). 
13 of the 19 responders had not progressed by the data cut off so their responses are ongoing and are censored at the date of the last evaluable visit before the data cut-off.

Duration of response

Number of months 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.

Comparison of PFS between patients randomised to cediranib 45 mg versus those randomised
to placebo.  All patients irrespective of whether they had a 12 week scan are included in this analysis.  At week 12 placebo patients were able to switch to cediranib.

Progression free survival

Number of patients with complete (CR) /partial response (PR) (based on RECIST).  CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD.  At 12 weeks, tumour responses would be unconfirmed, as this was the first post-baseline
RECIST assessment, unless a patient had a RECIST assessment before Week 12 to confirm a suspected progression.

Objective tumour response at 12 weeks

Best Objective Tumour response as defined by RECIST.  Patients were assigned to 1 of the following best objective tumour response categories: complete response (CR) defined as a Disappearance of all target lesions, partial response (PR), defined as At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD, stable disease (SD) defined as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started, or progressive disease (PD) defined as 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). Patients who were evaluable for RECIST assessments, but who did not meet the criteria for CR, PR, SD, or PD, were assigned to the response category of not evaluable (NE).

For the patients who switched from placebo to cediranib after unblinding, the baseline RECIST assessment was not reset to their last scan placebo, owing to the methods of data collection; therefore, it was not possible to determine their subsequent response to cediranib treatment using a ‘best response’ summary.

Arms	Assigned Interventions
Placebo Comparator: 1 Cediranib placebo	Drug: Cediranib Placebo oral tablet
Experimental: 2 Cediranib	Drug: Cediranib 45 mg oral tablet Other Name: AZD2171 Other Name: RECENTIN™

Cediranib (AZD2171, RECENTIN™) in Metastatic or Recurrent Renal Cell Carcinoma

Official Title

Medical condition

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Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

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Documents available

CSR-D8480C00030.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator