check_circleStudy Completed
Carcinoma, Renal Cell
Bayer Identifier:
16933
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Sorafenib as neoadjuvant therapy before cytoreductive nephrectomy in patients with metastatic renal cell carcinoma
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
61Trial Dates
January 2014 - December 2017Phase
N/ACould I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Russia |
Primary Outcome
- Maximum percent reduction (based on the minimum post baseline value) in the longest diameter of the primary tumor in response to neoadjuvant Nexavar treatment.date_rangeTime Frame:up to 2 yearsenhanced_encryptionNoSafety Issue:
- Response rate of residual disease to Nexavar according to RECIST 1.1 with baseline after cytoreductive nephrectomy.date_rangeTime Frame:up to 2 yearsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Response before cytoreductive nephrectomy according to RECIST 1.1.date_rangeTime Frame:up to 2 yearsenhanced_encryptionNoSafety Issue:
- Maximum percent reduction in the sum of longest diameters of target lesions according to RECIST 1.1 while on Nexavar treatment before cytoreductive nephrectomydate_rangeTime Frame:up to 2 yearsenhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:up to 2 yearsenhanced_encryptionNoSafety Issue:
- Number of participants with AEs, including intra- and postoperative complications, relation to Nexavar treatment, AEs treatment, AEs outcome.date_rangeTime Frame:up to 2 yearsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A