Trials / Completed
CompletedNCT00334282
Safety and Efficacy of GW786034 (Pazopanib) In Metastatic Renal Cell Carcinoma
A Randomised, Double-blind, Placebo Controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) Compared to Placebo in Patients With Locally Advanced and/or Metastatic Renal Cell Carcinoma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 435 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate efficacy and safety of pazopanib compared to placebo in patients with locally advanced and/ or metastatic renal cell carcinoma (RCC). Approximately 350-400 eligible patients will be stratified and randomized in a 2:1 ratio to receive either 800 mg pazopanib once daily or matching placebo. The study treatment will continue until patients experience disease progression, unacceptable toxicity or death. Primary objective of the study is to evaluate and compare the two treatment arms for progression-free survival. Principal secondary objective is to evaluate and compare the two treatment arms with respect to overall survival. Other objectives are overall response rate \[complete response (CR) + partial response (PR)\], rate of CR + PR + 6 months stable disease, and the incidence, severity and causality of adverse events and serious adverse events. Safety and efficacy assessments will be regularly performed on all patients. An Independent Data Monitoring Committee will be established to monitor safety during the course of the study and to evaluate interim efficacy data on overall survival.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pazopanib | Oral pazopanib tablet 800 mg once daily continuously |
| DRUG | placebo | matching placebo (800 mg tablet) once daily |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2008-05-01
- Completion
- 2014-12-01
- First posted
- 2006-06-07
- Last updated
- 2016-02-05
- Results posted
- 2010-08-02
Locations
99 sites across 25 countries: Argentina, Australia, Austria, Brazil, Chile, China, Czechia, Estonia, Greece, Hong Kong, India, Ireland, Italy, Latvia, Lithuania, Mexico, New Zealand, Pakistan, Poland, Russia, Slovakia, South Korea, Tunisia, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00334282. Inclusion in this directory is not an endorsement.