Overview

This trial is active, not recruiting.

Condition carcinoma, renal cell
Treatment sorafenib (nexavar, bay 43-9006)
Targets PDGF, VEGF, RAF, FLT-3, KIT
Sponsor Bayer
Start date January 2014
End date January 2017
Trial size 110 participants
Trial identifier NCT01982097, 16933, NX1307RU

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.

Primary Outcomes

Measure
Maximum percent reduction (based on the minimum post baseline value) in the longest diameter of the primary tumor in response to neoadjuvant Nexavar treatment.
time frame: up to 2 years
Response rate of residual disease to Nexavar according to RECIST 1.1 with baseline after cytoreductive nephrectomy.
time frame: up to 2 years

Secondary Outcomes

Measure
Response before cytoreductive nephrectomy according to RECIST 1.1.
time frame: up to 2 years
Maximum percent reduction in the sum of longest diameters of target lesions according to RECIST 1.1 while on Nexavar treatment before cytoreductive nephrectomy
time frame: up to 2 years
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.
time frame: up to 2 years
Number of participants with AEs, including intra- and postoperative complications, relation to Nexavar treatment, AEs treatment, AEs outcome.
time frame: up to 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Multicenter, Prospective, Non-interventional Study "Sorafenib as Neoadjuvant Therapy Before Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma"
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bayer.