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A Phase II Study of BAY 43-9006 Prior to and Following Nephrectomy in Patients With Metastatic Renal Cell Carcinoma.


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell

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Trial Information

A Phase II Study of BAY 43-9006 Prior to and Following Nephrectomy in Patients With Metastatic Renal Cell Carcinoma.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Best Overall Response Rate (complete and partial response rate)

Outcome Time Frame:

During study treatment or within 30 days after termination of active therapy

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

11547

NCT ID:

NCT00110344

Start Date:

November 2005

Completion Date:

June 2006

Related Keywords:

  • Carcinoma, Renal Cell
  • Cancer
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Boston, Massachusetts