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Home > "A" Clinical Trials Conditions > A Study to Estimate Safety and Efficacy of Bay 43-9006 in the Treatment of Hepatocellular Carcinoma  A Study to Estimate Safety and Efficacy of Bay 43-9006 in the Treatment of Hepatocellular Carcinoma
A Study to Estimate Safety and Efficacy of Bay 43-9006 in the Treatment of Hepatocellular Carcinoma
For Condition: Carcinoma, Hepatocellular
Status: Recruiting
Sponsor(s): Bayer Corporation ,
Synopsis: The study's primary objective is to evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinoma.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - biopsy-proven primary Hepatocellular Carcinoma - life expectancy of at least 12 weeks - inoperable tumor - patient considered appropriate for systemic therapy - at least one measurable lesion - have not received chemotherapy or immunotherapy - adequate bone morrow, liver and renal functions as determined by laboratory tests - cirrhotic status of Child's Pugh class A or B - Written Informed Consent form signed prior to start Exclusion Criteria: - congestive heart failure - serious cardiac arrhythmia - active coronary artery disease ischemia - active clinically serious infections - known history of HIV infection - known metastatic brain or meningeal tumors - history of seizure disorder - history of organ allograft - previous malignancy or other malignancies previously treated more than 3 years prior to entry - patients with clinically significant GI bleeding within one month of study entry
Total Enrollment: 232
Location and Contact Information:
Overall Study Official:
AmySpitzer, , Study Coordinator, Kenmar Research, 201 S. Alvardo St., Suite 809, Los Angeles, CA 90057
Mem. Sloan Kettering Cancer Center *Recruiting*
New York City, New York, 10022
United States
Recruiting Cyrus Pamela 203-812-2094
Metropolitan Hematology/Oncology Group *Recruiting*
Los Angeles, California, 90057
United States
Recruiting Peter Kennedy 213-484-6474
Additional Information:
Study ID Numbers: Protocol No. 10874; Bay 54-9085,(Bay 43-9006 tosylate salt),Raf Kinase Inhibitor
Study Start Date: August 2002
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044512
Other Carcinoma, Hepatocellular Studies:
1. Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads vs. IV Doxorubicin in Treating Liver Cancer
2. A Study to Estimate Safety and Efficacy of Bay 43-9006 in the Treatment of Hepatocellular Carcinoma
3. Testing of ADI-PEG in Hepatocellular Carcinoma
4. A Safety and Efficacy Study of DENSPM in Patients with Liver Cancer who are Not Eligible for Surgical Cure
5. A phase II multicenter uncontrolled trial of BAY 43-9006 in patients with advanced hepatocellular carcinoma
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A Study to Estimate Safety and Efficacy of Bay 43-9006 in the Treatment of Hepatocellular Carcinoma
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