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.
18 Years
N/A
Both
Renal Cell Carcinoma
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Percentage Change From Baseline in Tumour Size at 12 Weeks
Outcome Description:
Sum of longest diameters of the target lesions, based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria ((Week 12 - baseline)/baseline)*100
Outcome Time Frame:
Baseline to Week 12
Safety Issue:
No
Principal Investigator
Jane Robertson
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
D8480C00030
NCT ID:
NCT00423332
Start Date:
January 2007
Completion Date:
June 2013
Related Keywords:
- Renal Cell Carcinoma
- cancer
- tumour
- advanced cancer
- Metastatic renal cell carcinoma
- kidney cancer
- RECENTIN
- Carcinoma
- Carcinoma, Renal Cell
Name | Location |
|---|
