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

Renal Cell Carcinoma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00423332
• Other study ID #: D8480C00030
• Secondary ID: EudraCT no. 2006
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 16, 2007
• Last updated: July 6, 2016
• Start date: January 2007
• Est. completion date: January 2017

Study information

• Verified date: July 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: January 2017
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Confirmation of metastatic or recurrent renal cell carcinoma

Exclusion Criteria:

• Certain types of previous anti-cancer therapy for Renal Cell Carcinoma

• Patients with type I insulin-dependent diabetes or poorly-controlled type II insulin-independent diabetes

• Patients with a history of poorly controlled high blood pressure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• Cediranib
45 mg oral tablet
• Cediranib Placebo
oral tablet

Locations

Country	Name	City	State
Netherlands	Research Site	Groningen
Netherlands	Research Site	Leiden
Netherlands	Research Site	Nijmegen
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Northwood
United Kingdom	Research Site	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change From Baseline in Tumour Size at 12 Weeks	Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)*100	Baseline to Week 12	No
Secondary	Best Percentage Change From Baseline in Tumour Size During the Study	Maximum reduction or minimum increase in tumour size where size is the sum of the longest diameters of the target lesions	Treatment period up to Week 12 visit date for last patient in (LPI)	No
Secondary	Duration of Response	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.	Treatment period up to 2nd data cut-off of 8th March 2009	No
Secondary	Progression Free Survival	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.	Treatment period up to 2nd data cut-off of 8th March 2009.	No
Secondary	Objective Tumour Response at 12 Weeks	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.	Response rate at 12 weeks was based on RECIST measurements taken at baseline and at Week 12, or upon progression if this was before Week 12.	No
Secondary	Best Objective Tumour Response	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).	Baseline, Week 12 and every 8 weeks thereafter or until progression.	No

External Links

•   CSR-D8480C00030.pdf