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Home > "A" Clinical Trials Conditions > A Two Stage Study of the Safety and Efficacy of Bay 43-9006 in Colorectal Cancer and Other Cancers  A Two Stage Study of the Safety and Efficacy of Bay 43-9006 in Colorectal Cancer and Other Cancers
A Two Stage Study of the Safety and Efficacy of Bay 43-9006 in Colorectal Cancer and Other Cancers
For Condition: Colorectal Cancer,Tumors
Status: Completed
Sponsor(s): Bayer Corporation ,
Synopsis: Evaluation of Bay 43-9006 in patients primarily with colorectal cancer and other types of tumors by entering all patients into the study drug for 12 weeks (this is called the "run-in" period). Drug assignment or randomization in a second 12 week study will depend on results of the run-in period for each patient.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - age 18 years and above - patients with refractory solid cancer for which curative or palliative measures have failed or patients whose treatments are considered ineffective or intolerable - patients with non-colorectal cancers are eligible and must be progressing at the time of screening assessment and for whom no other treatment exists - histological or cytological documentation of cancer - life expectancy of at least 12 weeks - adequate bone marrow, liver and renal functions assessed by lab criteria within 7 days prior to screening - signed informed consent obtained prior to any study specific procedures Exclusion Criteria: - non-small cell lung cancer, hepatocellular cancer, CML and AMI - serious cardiac arrhythmia - congestive heart failure - active coronary artery disease or ischemia - active acute infections that could be worsened by anticancer therapy or interfere with the study - known HIV infection - metastatic brain or meningeal tumors - patients currently receiving medication (steroid or anticonvulsant therapy) for seizure disorder - history of organ allograft - chemotherapy, immunotherapy, radiotherapy or bone marrow transplant - pregnant or breast-feeding patients - substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results - known or suspected allergy to the investigational agent or any agent given in association with this trial - any condition that is unstable or could jeopardize the safety of the patient and/or their compliance with the study
Total Enrollment: 300
Location and Contact Information:
University of Chicago
Chicago, Illinois, 60637
United States
University of Texas
Houston, Texas, 77030
United States
Institute for Drug Development
San Antonio, Texas, 78229
United States
Additional Information:
Study ID Numbers: Protocol No. 100391;
Study Start Date: July 2002
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044499
Other Tumors Studies:
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2. Iressa to Treat Solid Tumors in Children
3. Study of Liposome Encapsulated Mitoxantrone (LEM) in Patients with Advanced Cancer
4. A Two Stage Study of the Safety and Efficacy of Bay 43-9006 in Colorectal Cancer and Other Cancers
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A Two Stage Study of the Safety and Efficacy of Bay 43-9006 in Colorectal Cancer and Other Cancers
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