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

February 6, 2018 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male and female patients ≥ 18 years old with untreated metastatic RCC for whom treatment with Nexavar is planned with subsequent cytoreductive nephrectomy and resumption of Nexavar in case of clinical feasibility

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Response before cytoreductive nephrectomy according to RECIST 1.1.
Time Frame: up to 2 years
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
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
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
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2014

Primary Completion (Actual)

January 31, 2017

Study Completion (Actual)

December 7, 2017

Study Registration Dates

First Submitted

November 6, 2013

First Submitted That Met QC Criteria

November 12, 2013

First Posted (Estimate)

November 13, 2013

Study Record Updates

Last Update Posted (Actual)

February 7, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16933 (IAEA)
  • NX1307RU (Other Identifier: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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