NCT01223027

Study of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma

An Open-label, Randomized, Multi-center, Phase III Study to Compare the Safety and Efficacy of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma After Failure of Anti-angiogenic (VEGF-targeted and mTOR Inhibitor) Therapies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 564 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients with metastatic renal cell cancer.

Conditions

• Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Dovitinib	Dovitinib is formulated as an oral gelatin capsule of 100 mg strength and was dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule. Medication labels complied withthe legal requirements of each country and were printed in the local language.
DRUG	Sorafenib	Sorafenib is formulated as a round, oral, biconvex, red film-coated tablet that contains 200 mg of sorafenib (tosylate). Sorafenib was administered twice daily without food at least 1 hour before or 2 hours after a meal. Sorafenib was supplied according to local practice.

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2010-10-18
• Last updated: 2015-12-07
• Results posted: 2015-11-06

Locations

199 sites across 27 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, Norway, Poland, Saudi Arabia, Slovakia, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom