Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma, Renal Cell
Intervention: Sorafenib (Nexavar, BAY43-9006); Placebo
Intervention description: Multi Kinase Inhibitor; Placebo
Intervention MeSH terms: Sorafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 903.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Renal Cell Cancer (RCC); Cancer

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with unresectable and/or metastatic, measurable renal cell carcinoma
             histologically or cytologically documented

          -  Patients must have had one prior systemic therapy for advanced disease, which was
             completed at least 30 days but no longer than 8 months prior to randomization

          -  Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI
             according to Response Evaluation Criteria in Solid Tumors (RECIST)

          -  Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of
             0 or 1

          -  Patients who have adequate coagulation, liver and kidney functions

        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:

               -  ECOG performance status greater than or equal to 2,

               -  Abnormally high lactate dehydrogenase,

               -  Abnormally high serum hemoglobin,

               -  Abnormally high corrected serum calcium,

               -  Absence of prior nephrectomy

          -  Excluded therapies and medications, previous and concomitant:

               -  Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except
                  biphosphonates

               -  Significant surgery with 4 weeks of start of study

               -  Investigational drug therapy during or within 30 days

               -  Concomitant treatment with rifampin or St. John's Wort

               -  Prior use of Raf-kinase inhibitors (RKI), MEK or Farnesyl transferase inhibitors

               -  Prior use of Bevacizumab, and all other drugs (investigational or licensed) that
                  target VEGF/VEGF receptors