At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed clear-cell RCC (excluding chromophobe, papillary, collecting duct, undifferentiated) that is metastatic or locally recurrent
- ✓Either no prior systemic therapy OR failed only 1 prior cytokine-based or bevacizumab-based therapy
- ✓Measurable disease documented by RECIST criteria
- ✓Age ≥21 years
- ✕Prior non-cytokine or non-bevacizumab therapies (other than 1 allowed prior cytokine/bevacizumab regimen)
- ✕Prior chemotherapy for RCC
- ✕Major surgery, radiotherapy, or immunotherapy within 28 days before enrollment
- ✕History of hypercalcemia within 2 months of therapy start
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of GW786034 Using a Randomised Discontinuation Design in Subjects With Locally Recurrent or Metastatic Clear-Cell Renal Cell Carcinoma
In Brief
A Phase 2 clinical trial evaluating GW786034 and Placebo for Carcinoma, Renal Cell. Completed, enrolled 225 participants across 45 sites in 8 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.