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

Completed · Phase 3 · Has a placebo group

Conditions studied: Carcinoma, Renal Cell

In brief

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.

Key facts

Study ID

NCT00073307

Run by

Bayer

People needed

903

Starts

2003-11-01

Expected to finish

2010-04-01

Last updated by the study team

2014-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Sacramento, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Hamden, Connecticut, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Louisville, Kentucky, United States
• Study site — Lafayette, Louisiana, United States
• Study site — Frederick, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Columbia, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Brooklyn, New York, United States
• Study site — New York, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Canton, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Dayton, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Spartanburg, South Carolina, United States
• Study site — Dallas, Texas, United States
• Study site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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