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Record 4

Study #CRAD001L2404

Condition / Intervention

Kidney (renal cell) Cancer


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.


Neal A Fischbach, MD

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For more information about this study and to inquire about eligibility, (203) 384-3611

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Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • 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

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