Sorafenib as Neoadjuvant Therapy Before Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma (SANE)

Bayer

Status: Completed

Conditions: Carcinoma, Renal Cell

Treatments: Drug: Sorafenib (Nexavar, BAY 43-9006)

Study type: Observational

Funder types: Industry

Identifiers

NCT01982097

16933

NX1307RU (Other Identifier)

Details and patient eligibility

About

This local, prospective, multicenter, non-interventional study documents observational data on patients under routine treatment of metastatic RCC with Nexavar before and after cytoreductive nephrectomy. It's planned to better understand the impact of cytoreductive nephrectomy on Nexavar efficacy and possibly to define patients who get the most benefit from Nexavar before cytoreductive nephrectomy.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Male and female patients ≥ 18 years old
• Patients with untreated metastatic RCC in whom a decision on neoadjuvant treatment with Nexavar before cytoreductive nephrectomy and in case of clinical feasibility resumption of treatment with Nexavar after nephrectomy has been made at the time of study enrollment
• Life expectancy of at least 16 weeks
• Patients should have signed informed consent form

Exclusion criteria

• Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer.

• All contra-indications according to the Russian marketing authorization:

  • Hypersensitivity to sorafenib or to any of the excipients.
  • Pregnancy and breast-feeding.
  • Age less than 18 years.

Trial design

61 participants in 1 patient group

Group 1

Treatment:

Drug: Sorafenib (Nexavar, BAY 43-9006)