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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

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Starting date: January 2014
Last updated: August 10, 2015

Page last updated: August 23, 2015

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