Conditions: Metastatic Renal Cell Carcinoma
Keywords: advanced kidney cancer everolimus kidney cancer oral therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 416
Healthy volunteers: no

Brief summary:
To assess whether daily treatment with RAD001 could slow the growth and spread of metastatic carcinoma of the kidney. The safety of RAD001 was also to be studied in this trial.

Detailed description:

Arms:
arm 1: The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day. arm 2: Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.

Interventions: intervention 1: RAD001 intervention 2: Placebo
Intervention descriptions: intervention 1: The dose of RAD001 was 10 mg/day. Patients were instructed to take two tablets (5 mg each) by mouth every day. intervention 2: None

Protocol document: