Trial Information

Summary: A Phase I Study of Asonep in Subjects with Refractory Advanced Solid Tumors

The purpose of this study is to determine the safety and tolerability of ASONEP when administered to patients with advanced solid tumors. The study will assess the effects of the drug on patients and their cancers by assessing the patients' side effects and through pharmacokinetics. Pharmacokinetics (PKs) is a way to determine the amount of drug in the patient's blood and studies how the body processes, distributes, metabolizes and eliminates the drug. This is done by frequent blood draws during the first four weeks of treatment.

ASONEP is a targeted therapy and is a humanized monoclonal antibody that is given intravenously weekly. It targets the signaling pathway that leads to cell proliferation and angiogenesis. It is believed the interruption of this pathway will lead to death of the cancer cell. ASONEP is not approved by the FDA and is considered investigational in this study.

Patient Inclusion Criteria:

• Adequate physical integrity of upper GI tract
• Adequate liver, kidney and bone marrow function
• Evaluable disease allowed
• Brain mets allowed if stable for 8 weeks and off steroids for 4 weeks

Patient Exclusion Criteria: History of alcohol or other substance abuse within 1 year

If you would like to learn more about participating in this study, please send an e-mail message using the form below.