At a glance
ClinicalIndex Comparison Record- ✓Unresectable and/or metastatic, measurable, predominantly clear cell RCC (histologically or cytologically documented)
- ✓Prior complete surgical excision of primary RCC tumor
- ✓At least one uni-dimensional measurable lesion by CT or MRI per RECIST
- ✓ECOG performance status 0 or 1
- ✕Prior systemic therapy for advanced RCC (chemotherapy, immunotherapy, investigational agents, or megestrol acetate/medroxyprogesterone)
- ✕Complete renal shut-down requiring hemo- or peritoneal dialysis
- ✕Congestive heart failure >NYHA class 2, active cardiovascular disease, cardiac arrhythmia requiring anti-arrhythmic therapy, or uncontrolled hypertension
- ✕Symptomatic metastatic brain or meningeal tumors (unless >6 months from definitive therapy with negative imaging within 4 weeks and clinically stable)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Open-label, Multi-centre Phase II Study of BAY43-9006 (Sorafenib) Versus Standard Treatment With Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma.
In Brief
A Phase 2 clinical trial evaluating Sorafenib (Nexavar, BAY43-9006) and Interferon for Carcinoma, Renal Cell. Completed, enrolled 189 participants across 42 sites in 7 countries.
Detailed Summary
The purpose of the study is to: * Find out if patients receiving BAY43-9006 will live longer without tumor progression than those receiving standard therapy with interferon alpha-2a * Find out if a higher dose of BAY43-9006 can inhibit tumor progression in patients who progressed during standard dose treatment with BAY43-9006, and for how long these patients live without progression * Find out how long patients live without progression who receive BAY43-9006 after failing to respond to standard therapy with interferon alpha-2a * Find out in how many percent of patients BAY43-9006 prevents the growth of or shrinks kidney tumors and/or their metastases depending on treatment and dosage * Find out if BAY43-9006 has any effect on the quality of life of patients with kidney cancer * Find out the level of BAY43-9006 in the blood once per month and any changes in this level * Find out whether BAY43-9006 effects are associated with specific biomarkers
Study Details
Timeline
Interventions
Multi kinase inhibitor
Interferon