|Condition / Intervention ||Kidney (renal cell) Cancer|
|Title ||Record 4|
|Study # ||CRAD001L2404|
|Purpose ||An open label, multi-center, phase II study to examine the effacacy and safety of everolimus as second line therapy in the treatment of patients with metastatic renal cell carcinoma.|
|Investigator || Neal A Fischbach MD|
|Contact Information ||For more information about this study and to inquire about eligibility, 203-384-3611|
|Contact Us ||Use this form to email us|
|More Information ||View this trial on ClinicalTrials.gov|
- Advanced renal cell carcinoma of a histological or cytological confirmation of clear cell (or with a component of clear cell) renal carcinoma that have previously progressed on or were intolerant to first-line therapy with sunitinib, sorafenib, pazopanib, axitinib, bevacizumab, or cytokine therapy.
- Prior nephrectomy (partial or total)
- Patients with at least one measurable lesion at baseline as per the RECIST 1.0 criteria
- Karnofsky Performance Status ≥ 70%
- Patients who have received more than one prior treatment regimen for metastatic renal-cell carcinoma
- Patients who have received adjuvant therapy for RCC
- Patients who have previously received systemic mTOR inhibitors (eg, sirolimus, temsirolimus, everolimus)
- Patients with brain metastases
- Patients within 4 weeks post-major surgery, open biopsy, or significant traumatic injury to avoid wound healing complications.
- Patients who had radiation therapy within 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed up to 2 weeks prior to study treatment start).
- Concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
Other protocol-defined inclusion/exclusion criteria may apply