Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborators: Amgen; Onyx Pharmaceuticals
• Treatments: Niacinamide; Sorafenib

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