Overview

Sequential Study to Treat Renal Cell Carcinoma

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
Primary: To evaluate if progression-free survival from first treatment to progression or death during second-line therapy (total PFS) of sorafenib followed by sunitinib is superior compared to sunitinib followed by sorafenib. Secondary: 1. Time from first treatment to progression during second-line therapy (total TTP) 2. Time to first-line treatment failure (progression, death, discontinuation due to toxicity) descriptively in each arm 3. PFS in first-line and second-line treatment, descriptively 4. Overall survival, descriptively (data cut-off same as for primary endpoint) 5. Disease Control Rate (DCR); Response rates in first-line and in second-line (CR, PR, SD according to RECIST criteria) 6. Cardiotoxicity analysis by means of echocardiography and NT-pro BNP with an interim analysis after 100 patients of each arm have completed the study 7. Safety and tolerability
Phase:
Phase 3
Details
Lead Sponsor:
Sponsor GmbH
Collaborator:
iOMEDICO AG
Treatments:
Niacinamide
Sorafenib
Sunitinib