Back to resultsResearch Study for Patients With Metastatic Renal Cell Carcinoma
Primary Purpose
Carcinoma, Renal Cell
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nexavar (Sorafenib, BAY43-9006)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Best Overall Response Rate (complete and partial response rate)
Secondary Outcome Measures
Progression-free survival
Overall response rate
Time to response
Safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00110344
Brief Title
Research Study for Patients With Metastatic Renal Cell Carcinoma
Official Title
A Phase II Study of BAY 43-9006 Prior to and Following Nephrectomy in Patients With Metastatic Renal Cell Carcinoma.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Study Start Date
November 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study has been designed to study patients diagnosed with advanced renal cell cancer with the primary tumor in place.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell
Keywords
Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Nexavar (Sorafenib, BAY43-9006)
Intervention Description
Cycle 1. Patients are randomized in a double-blind fashion to receive either Nexavar (Sorafenib, BAY 43-906; this arm) or matching placebo (see below) for 14 days. Dose range will be depending on hematologic and other toxicity between 400 mg (2 tablets of 200 mg) orally twice bid and 400 mg orally every 2 days. Cycle 2: patients who are eligible undergo nephrectomy. After the post-nephrectomy recovery period, all patients will receive 400 mg of BAY 43-906, twice daily (administered as two 200 mg tablets) in an open-label fashion.Cycle 3+: 400 mg of BAY 43-906, twice daily (administered as two 200 mg tablets) in an open-label fashion.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Cycle 1. Patients are randomized in a double-blind fashion to receive either Nexavar (see above) or matching placebo (this arm) for 14 days. Dose range will be depending on hematologic and other toxicity between 400mg (2 tablets of 200mg) orally twice bid and 400mg orally every 2 days. Cycle 2 and 3: see above (no placebo application)
Primary Outcome Measure Information:
Title
Best Overall Response Rate (complete and partial response rate)
Time Frame
During study treatment or within 30 days after termination of active therapy
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
Last date of tumor assessment
Title
Overall response rate
Time Frame
Last day of tumor assessement
Title
Time to response
Time Frame
throughout study
Title
Safety
Time Frame
all visits
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115-6084
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Research Study for Patients With Metastatic Renal Cell Carcinoma
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