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Sponsored by: |
Erimos Pharmaceuticals |
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Information provided by: | Erimos Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00259818 |
This is a Phase I, dose escalation study of EM-1421 administered by intravenous infusion (IV) for five consecutive days every 28 days to patients with solid tumors refractory to current therapies. There have been no previous human studies of intravenous (into one's vein) EM-1421 treatment; however, lab research (research in test tubes and/or animals) suggests that EM-1421 has shown some activity against tumors in animals. This activity in animal models suggests that EM-1421 may be a useful chemotherapy for human cancer.
The primary objective of this study is to determine the safety and maximum tolerated dose of EM-1421 given by intravenous infusion. The efficacy of the treatment will also be measured.
Condition | Intervention | Phase |
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Cancer |
Drug: EM-1421 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Phase I Dose Escalation Study of Intravenous Infusion of Tetra-O-Methyl Nordihydroguaiaretic Acid (EM-1421) in Subjects With Refractory Malignant Tumors |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Premiere Oncology of Arizona | |
Scottsdale, Arizona, United States | |
United States, New York | |
Albert Einstein College of Medicine | |
Bronx, New York, United States | |
United States, Tennessee | |
Sarah Cannon Cancer Center | |
Nashville, Tennessee, United States |
Investigator: | Neil Frazer, MB | Erimos Pharmaceuticals |
Study ID Numbers: | EM-1421 #101 |
Study First Received: | November 30, 2005 |
Last Updated: | January 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00259818 |
Health Authority: | United States: Food and Drug Administration |
Refractory Solid Tumors |
Nordihydroguaiaretic Acid Recurrence |
Anti-Inflammatory Agents Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Protective Agents Lipoxygenase Inhibitors Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |