check_circleStudy Completed

Carcinoma, Renal Cell

Bayer Identifier:

16933

ClinicalTrials.gov Identifier:

NCT01982097

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

Both

Age

18 - N/A
  • - - 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



  • - 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 summary

Enrollment Goal
61
Trial Dates
January 2014 - December 2017
Phase
N/A
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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 years
    enhanced_encryption
    Safety Issue:
    No
  • Response rate of residual disease to Nexavar according to RECIST 1.1 with baseline after cytoreductive nephrectomy.
    date_rangeTime Frame:
    up to 2 years
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Response before cytoreductive nephrectomy according to RECIST 1.1.
    date_rangeTime Frame:
    up to 2 years
    enhanced_encryption
    Safety Issue:
    No
  • Maximum percent reduction in the sum of longest diameters of target lesions according to RECIST 1.1 while on Nexavar treatment before cytoreductive nephrectomy
    date_rangeTime Frame:
    up to 2 years
    enhanced_encryption
    Safety Issue:
    No
  • 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 years
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with AEs, including intra- and postoperative complications, relation to Nexavar treatment, AEs treatment, AEs outcome.
    date_rangeTime Frame:
    up to 2 years
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Multicenter, prospective, non-interventional study “Sorafenib as neoadjuvant therapy before cytoreductive nephrectomy in patients with metastatic renal cell carcinoma”
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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