A Study of ATN-224 and Bortezomib in Patients With Multiple Myeloma
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First Received Date ICMJE | July 13, 2006 | ||||
Last Updated Date | October 27, 2008 | ||||
Start Date ICMJE | June 2006 | ||||
Estimated Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00352742 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Descriptive Information | |||||
Brief Title ICMJE | A Study of ATN-224 and Bortezomib in Patients With Multiple Myeloma | ||||
Official Title ICMJE | A Phase I/II Study of ATN-224 and Bortezomib in Patients With Multiple Myeloma Relapsed From or Refractory to Bortezomib | ||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Multiple Myeloma | ||||
Intervention ICMJE | Drug: ATN-224 + bortezomib
ATN-224 and bortezomib dose to be determined in Phase I portion of study |
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Study Arm (s) | Experimental: 1
ATN-224 + bortezomib
Intervention: Drug: ATN-224 + bortezomib |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Estimated Enrollment ICMJE | 46 | ||||
Estimated Completion Date | December 2008 | ||||
Estimated Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00352742 | ||||
Other Study ID Numbers ICMJE | ATN-224-007 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | Jennifer Callahan, Senior Manager, Clinical Development, Attenuon, LLC | ||||
Study Sponsor ICMJE | Attenuon | ||||
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Investigators ICMJE |
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Information Provided By | Attenuon | ||||
Verification Date | October 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |