This trial is active, not recruiting.

Condition renal cell carcinoma
Treatments cediranib, cediranib placebo
Phase phase 2
Target VEGF
Sponsor AstraZeneca
Start date January 2007
End date March 2008
Trial size 105 participants
Trial identifier NCT00423332, D8480C00030, EudraCT no. 2006-002455-33


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Placebo Comparator)
Cediranib placebo
cediranib placebo
oral tablet
cediranib AZD2171
45 mg oral tablet

Primary Outcomes

Percentage Change From Baseline in Tumour Size at 12 Weeks
time frame: Baseline to Week 12

Secondary Outcomes

Best Percentage Change From Baseline in Tumour Size During the Study
time frame: Treatment period up to Week 12 visit date for last patient in (LPI)
Duration of Response
time frame: Treatment period up to 2nd data cut-off of 8th March 2009
Progression Free Survival
time frame: Treatment period up to 2nd data cut-off of 8th March 2009.
Objective Tumour Response at 12 Weeks
time frame: 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.
Best Objective Tumour Response
time frame: Baseline, Week 12 and every 8 weeks thereafter or until progression.

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.