RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed After Treatment With Sorafenib and/or Sunitinib
Condition: Metastatic Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: RAD001; Placebo
Intervention description: The dose of RAD001 was 10 mg/day. Patients were instructed to take two tablets (5 mg each) by mouth every day.
Intervention MeSH terms: Everolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 416.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: advanced kidney cancer; everolimus; kidney cancer; oral therapy

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with metastatic carcinoma and with histological or cytological confirmation
             of clear cell RCC (tissue from the original diagnosis of renal cell cancer is
             acceptable).

          -  The date of progression on sunitinib and/or sorafenib must be within 6 months.

          -  Patients may have received one or both agents

          -  Prior therapy with cytokines (i.e., IL-2, Interferon) and/or VEGF-ligand inhibitors
             (i.e., bevacizumab) are permitted.

          -  Prior vaccine therapy in the adjuvant setting is permitted.

          -  Patients with at least one measurable lesion at baseline as per the Response
             evaluation criteria in solid tumors (RECIST) criteria, either on physical exam or as
             determined by Computer Tomography (CT) Scan or Magnetic Resonance Imaging (MRI).

          -  Patients with a Karnofsky Performance Status ≥70%.

          -  Adequate bone marrow, liver and renal function.

          -  Patients with a life expectancy ≥ 3 months.

          -  Women of childbearing potential must have had a negative serum or urine pregnancy test
             48 hours prior to the administration of the first study treatment.

          -  Patients who give a written informed consent obtained according to local guidelines

        Exclusion Criteria:

          -  Patients currently receiving chemotherapy, immunotherapy, or radio-therapy or who have
             received these within 4 weeks of study entry

          -  Patients who have previously received mTOR inhibitors.

          -  Patients with a known hypersensitivity to RAD001 or other rapamycins (sirolimus,
             temsirolimus) or to its excipients.

          -  Patients with untreated CNS metastases or who are neurologically unstable despite
             treatment of the CNS metastases. (Patients with treated CNS metastases, who are
             neurologically stable off of corticosteroids, are eligible to enter study).

          -  Patients receiving chronic treatment with corticosteroids or another immunosuppressive
             agent

          -  Patients with a known history of HIV seropositivity.

          -  Patients with an active, bleeding diathesis or on oral anti-vitamin K medication
             (except low dose coumadin)

          -  Patients who have any severe and/or uncontrolled medical conditions

          -  Patients who have a history of another primary malignancy ≤ 3 years, with the
             exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix

          -  Female patients who are pregnant or breast feeding, or adults of reproductive
             potential who are not using effective birth control methods. If barrier contraceptives
             are being used, these must be continued throughout the trial by both sexes.

          -  Patients who are using other investigational agents or who had received
             investigational drugs ≤ 4 weeks prior to randomization

          -  Patients unwilling to or unable to comply with the protocol

        Other protocol-defined inclusion/exclusion criteria may apply.