Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 to 90	Pharmaceutical / Industry	CRAD001C2240 NCT00410124

Trial Description

Summary

To assess whether daily treatment with everolimus can slow the growth and spread of metastatic carcinoma of the kidney. The safety of everolimus will also be studied in this trial.

Eligibility Criteria

Inclusion

• 18 years of age or older

• 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 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

• 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 everolimus 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Novartis Pharmaceuticals Corporation

Novartis

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00410124
Information obtained from ClinicalTrials.gov on March 18, 2009