NCT02689167

Study to Assess Various Sunitinib Schedules in Renal Cell Carcinoma

Open Label, Randomised Multi-centre Phase II Study to Assess the Efficacy and Tolerability of Sunitinib by Dose Administration Regimen (Dose Modification or Dose Interruptions) in Patients With Advanced or Metastatic Renal Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients who are candidates for first line treatment with Sunitinib 50mg 4/6 regimen in accordance with the Marketing Authorisation who meet the inclusion/exclusion criteria will be offered participation in this study during the consultation as part of their usual care. The patients will be included before Sunitinib treatment is started. Thereafter, sunitinib is initiated 50 mg/day; regimen 4/6 (Marketing Authorisation Indication), 4 weeks "on " alternating with 2 weeks "off " As soon as a dose or schedule adjustment is required, regardless of cause, the patient will be randomised 1/1: * Either into arm A and will receive 37.5mg of Sunitinib per day by the 4/6 regimen (in accordance with the Marketing Authorisation); 4 weeks "on " alternating with 2 weeks "off " * Or into arm B and will receive 50mg of Sunitinib per day by the 2/3 regimen (investigational arm); 2 weeks "on " alternating with 1 week "off "

Conditions

• Kidney Neoplasms
• Metastatic Renal Cell Cancer

Interventions

Type	Name	Description
DRUG	Sunitinib

Timeline

• Start date: 2016-02-19
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2016-02-23
• Last updated: 2021-11-29

Locations

1 site across 1 country: France