NCT00244764

GW786034 In Subjects With Locally Recurrent Or Metastatic Clear Cell Renal Cell Carcinoma

A Phase II Study of GW786034 Using a Randomised Discontinuation Design in Subjects With Locally Recurrent or Metastatic Clear-Cell Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Phase II, multi-center, two-stage study utilising a randomised discontinuation design to evaluate the safety and efficacy of GW786034 (pazopanib) in adult subjects with locally recurrent or metastatic clear-cell Renal Cell Carcinoma (RCC). After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	GW786034	All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.
DRUG	Placebo	All patients receive GW786034. At week 12, some subjects will be randomized based on response (SD) and the others will remain on drug. After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-03-01
• Completion: 2013-09-01
• First posted: 2005-10-27
• Last updated: 2017-03-27
• Results posted: 2011-01-25

Locations

45 sites across 8 countries: United States, Australia, Belgium, China, Czechia, Hong Kong, Israel, Taiwan