Research Study for Patients With Metastatic Renal Cell Carcinoma

Phase 2

Terminated

• Conditions: Carcinoma, Renal Cell
• Interventions: Drug: Nexavar (Sorafenib, BAY43-9006); Drug: Placebo

• Registration Number: NCT00110344
• Lead Sponsor: Bayer

Brief Summary

This study has been designed to study patients diagnosed with advanced renal cell cancer with the primary tumor in place.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-05-06
• Study First Submitted QC: 2005-05-06
• Study First Posted: 2005-05-09
• Study Start: 2005-11
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-10
• Last Update Posted: 2013-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Life expectancy of at least 12 weeks
• Clinical, radiographic, or pathologic diagnosis of metastatic renal cell carcinoma (RCC). All renal cell histologies are allowed- Acceptable surgical risk in the judgment of the study investigator and consulting urological surgeon
• At least one uni-dimensional measurable lesion outside the planned nephrectomy specimen
• Patients who have an ECOG performance status of 0 or 1

Exclusion Criteria

• History of bleeding diathesis or unexpected surgical bleeding- Patients currently receiving treatment with or having a requirement for therapeutic anticoagulation
• Prior therapy for RCC. Palliative radiation therapy for painful or unstable bone metastases is permitted provided that there is measurable metastatic disease outside the radiation field
• Known history of HIV infection- Symptomatic metastatic brain or meningeal tumors, unless the patient is > 6 months from definitive therapy, has a CT or MRI scan within 6 weeks of study entry negative for brain metastases and is clinically stable with respect to the tumor at the time of study entry

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Nexavar (Sorafenib, BAY43-9006)	-
Arm 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Best Overall Response Rate (complete and partial response rate)	During study treatment or within 30 days after termination of active therapy

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Last date of tumor assessment
Safety	all visits
Overall response rate	Last day of tumor assessement
Time to response	throughout study