A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.
A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.
The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.
Overall Survival (OS), Patient-reported outcome (PRO)
Inclusion Criteria:
Exclusion Criteria:
Patients with rare subtypes of renal cell carcinoma (RCC) such as pure papillary cell tumors, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors
Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma,or superficial bladder tumors, or other malignancies curatively treated > 2 years prior to entry
Cardiac arrhythmias requiring anti-arrhythmics, symptomatic coronary artery disease or ischemia or congestive heart failure
Patients with a history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
Patients with a history or presence of metastatic brain or meningeal tumors
Patients with seizure disorder requiring medication (such as anti-epileptics)
History of organ allograft or bone marrow transplant of stem cell rescue
Patients who are pregnant or breast-feeding Women of childbearing potential must have a negative pregnancy test prior to drug administration. Both men and women enrolled in this trial must use adequate birth control
Patients who have three or more of the following:
Excluded therapies and medications, previous and concomitant:
Capital Federal-Buenos Aires, C1426ANZ, Argentina
Bruxelles - Brussel, 1000, Belgium
Bruxelles - Brussel, 1090, Belgium
Cruces/Barakaldo, Bilbao 48903, Spain