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Sponsored by: |
Attenuon |
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Information provided by: | Attenuon |
ClinicalTrials.gov Identifier: | NCT00352742 |
The purpose of this study is to describe the safety and effect of ATN-224 in combination with bortezomib (Velcade®) in patients with Multiple Myeloma who are relapsed from or refractory to bortezomib.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: ATN-224 + bortezomib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of ATN-224 and Bortezomib in Patients With Multiple Myeloma Relapsed From or Refractory to Bortezomib |
Estimated Enrollment: | 46 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
ATN-224 + bortezomib
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Drug: ATN-224 + bortezomib
ATN-224 and bortezomib dose to be determined in Phase I portion of study
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Multiple myeloma is a bone marrow based malignancy of plasma cells that is highly treatable but rarely curable. Angiogenesis, defined as the growth of new blood vessels from pre-existing vessels, is a requirement for the growth of nearly all tumors. An increase in bone marrow angiogenesis is present in Multiple Myeloma and correlates with disease progression. Several new therapies that target angiogenic pathways have shown clinical efficacy. ATN-224 is a small molecule that has been shown in pre-clinical studies to be antiangiogenic.
Using one agent to overcome resistance of another agent is a treatment regimen used in oncology. A preclinical study with the combination of ATN-224 and bortezomib shows that the combination is more effective than either single agent in a bortezomib resistant cell line.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ and marrow function as defined below:
Patients are allowed to receive blood transfusions before receiving their first dose of ATN-224 to bring the hemoglobin level to ≥8 g/dL to meet eligibility criteria.
Exclusion Criteria:
United States, California | |
Institute for Myeloma and Bone Cancer Research | |
West Hollywood, California, United States, 90069 | |
Hematolgy-Oncology Medical Group of Fresno, Inc. | |
Fresno, California, United States, 93720 | |
United States, Florida | |
Florida Cancer Specialists | |
Fort Myers, Florida, United States, 33901 | |
United States, Maryland | |
Center for Cancer and Blood Disorders | |
Bethesda, Maryland, United States, 20817 | |
United States, Montana | |
Billings Clinic | |
Billings, Montana, United States, 59101 | |
United States, New Jersey | |
The Cancer Institute of New Jersey | |
New Brunswick, New Jersey, United States, 08903 | |
United States, New York | |
SUNY Downstate | |
Brooklyn, New York, United States, 11203 | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263 | |
United States, Texas | |
Mary Crowley Medical Research Center | |
Dallas, Texas, United States, 75246 | |
Tyler Cancer Center | |
Tyler, Texas, United States, 75702 |
Study Director: | Gilad Gordon, MD |
Responsible Party: | Attenuon, LLC ( Jennifer Callahan, Senior Manager, Clinical Development ) |
Study ID Numbers: | ATN-224-007 |
Study First Received: | July 13, 2006 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00352742 |
Health Authority: | United States: Food and Drug Administration |
Multiple myeloma bortezomib ATN-224 |
refractory relapsed antiangiogenic |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Cardiovascular Diseases Pharmacologic Actions Protease Inhibitors |