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

Carcinoma, Renal Cell Clinical Trial

— SANE  

Official title:

Multicenter, Prospective, Non-interventional Study "Sorafenib as Neoadjuvant Therapy Before Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982097
• Other study ID #: 16933
• Secondary ID: NX1307RU
• Status: Completed
• Phase: N/A
• First received: November 6, 2013
• Last updated: February 6, 2018
• Start date: January 10, 2014
• Est. completion date: December 7, 2017

Study information

• Verified date: February 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 7, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• Sorafenib (Nexavar, BAY 43-9006)
The patients under routine treatment of metastatic RCC with Nexavar before and after cytoreductive nephrectomy meeting the criteria of inclusion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum percent reduction (based on the minimum post baseline value) in the longest diameter of the primary tumor in response to neoadjuvant Nexavar treatment.		up to 2 years
Primary	Response rate of residual disease to Nexavar according to RECIST 1.1 with baseline after cytoreductive nephrectomy.		up to 2 years
Secondary	Response before cytoreductive nephrectomy according to RECIST 1.1.		up to 2 years
Secondary	Maximum percent reduction in the sum of longest diameters of target lesions according to RECIST 1.1 while on Nexavar treatment before cytoreductive nephrectomy		up to 2 years
Secondary	Maximum percent reduction in the sum of longest diameters of target lesions of residual disease after cytoreductive nephrectomy according to RECIST 1.1 while on Nexavar treatment with baseline after cytoreductive nephrectomy.		up to 2 years
Secondary	Number of participants with AEs, including intra- and postoperative complications, relation to Nexavar treatment, AEs treatment, AEs outcome.		up to 2 years

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