Sorafenib as Neoadjuvant Therapy Before Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Carcinoma, Renal Cell
Intervention: Sorafenib (Nexavar, BAY 43-9006) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact: Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
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.
Clinical Details
Official title: Multicenter, Prospective, Non-interventional Study "Sorafenib as Neoadjuvant Therapy Before Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma"
Study design: Observational Model: Cohort, Time Perspective: Prospective
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.Response rate of residual disease to Nexavar according to RECIST 1.1 with baseline after cytoreductive nephrectomy.
Secondary outcome: Response before cytoreductive nephrectomy according to RECIST 1.1.Maximum percent reduction in the sum of longest diameters of target lesions according to RECIST 1.1 while on Nexavar treatment before cytoreductive nephrectomy 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. Number of participants with AEs, including intra- and postoperative complications, relation to Nexavar treatment, AEs treatment, AEs outcome.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Many Locations, Russian Federation; Recruiting
Additional Information
Click here and search for drug information provided by the FDA. Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
Starting date: January 2014
Last updated: August 10, 2015
|