Studienregister der Deutschen Gesellschaft für Urologie e.V.

AN 25/07


A Randomized Trial of Temsirolimus Versus Sorafenib as Second-Line Therapy in Patients With Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy

Status: Active

Purpose / Objectives


Patient attributes





Inclusion criteria

- Age 18 or older
- Histologically confirmed diagnosis of mRCC (regardless of histology or nephrectomy status) with well-documented Radiological PD by RECIST criteria or clinical PD as judged by the investigator while receiving first-line sunitinib therapy. Subjects must have at least 1 cycle of sunitinib therapy (minimum of four weeks continuously).
- At time of randomization, at least 2 weeks since prior treatment with sunitinib, palliative radiation therapy, and/or surgery.
- At time of randomization, there must be at least 1 measurable lesion per RECIST. Lesions that have been previously irradiated or embolized cannot be selected as target lesions

Exclusion criteria

- Metastatic CNS from RCC.
- Subjects who discontinued Sutent therapy due specifically to intolerance.
- Prior systemic therapy for mRCC other than sunitinib.
- Active ketonuria, secondary to poorly controlled diabetes mellitus

Trial design

  • Multicenter
  • Prospective
  • Randomized
  • Two-arm

Documents (password protected)

Responsibilities in overall trial

National Coordinating Investigator

Prof. Dr. med. Jürgen Gschwend

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