Conditions: Metastatic Renal Cell Carcinoma
Keywords: Dovitinib TKI Renal cell cancer RCC mRCC
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 564
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib orally on 5 days on/2 days off dosing schedule. arm 2: Patients in the sorafenib control arm received400 mg of sorafenib (2 x 200 mg tablets) orally taken twice daily.

Interventions: intervention 1: Dovitinib intervention 2: Sorafenib
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: