Conditions: Renal Cell Carcinoma
Keywords: RAD001 everolimus sunitinib renal cell carcinoma kidney cancer metastatic renal cell cancer advanced kidney cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 471
Healthy volunteers: no

Brief summary:
This study assessed the efficacy and safety of first-line RAD001 followed by second-line sunitinib versus the opposite sequence: first-line sunitinib followed by second-line RAD001 for the treatment of patients with MRCC.

Detailed description:

Arms:
arm 1: everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) arm 2: sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment

Interventions: intervention 1: everolimus intervention 2: sunitinib
Intervention descriptions: intervention 1: Everolimus was administered orally at 10 mg/day. Everolimus is formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets. intervention 2: Sunitinib was administered orally 50 mg daily, on a schedule of 4 weeks on/2 weeks off. Sunitinib was supplied as hard gelatin capsules of 12.5 mg, 25 mg, or 50 mg strength according to local practice.

Protocol document: