Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Nereus Pharmaceuticals, Inc. |
---|---|
Information provided by: | Nereus Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00461045 |
This is a Phase 1 clinical trial examining the safety, pharmacokinetics and pharmacodynamics of escalating doses of the proteasome inhibitor NPI-0052 in patients with relapsed or relapsed/refractory multiple myeloma. By inhibiting proteasomes NPI-0052 prevents the breakdown of proteins involved in signal transduction, which blocks growth and survival in cancer cells.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: NPI-0052 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 1 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma |
Estimated Enrollment: | 35 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
NPI-0052: Experimental
NPI-0052
|
Drug: NPI-0052
I.V. injection on Days 1, 8 and 15 every 28 days
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Angie Longenecker, RN | 858-200-8354 | alongenecker@nereuspharm.com |
Contact: Matthew A Spear, M.D., Chief Medical Officer, Nereus Pharmaceuticals |
United States, Illinois | |
University of Chicago, School of Medicine | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Monica Mitchell, RN 773-834-5358 mmitche1@medicine.bsd.uchicago.edu | |
Principal Investigator: Todd Zimmerman, M.D. | |
United States, Massachusetts | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Katie Loftus 617-632-4694 katie_loftus@dfci.harvard.edu | |
Principal Investigator: Paul Richardson, M.D. | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Colleen Harvey, Study Coord. 734-936-6936 ckharvey@med.umich.edu | |
Contact: Andrzej Jakubowiak, MD PhD ajakubow@umich.edu | |
Principal Investigator: Andrzej Jakubowiak, MD PhD | |
United States, Ohio | |
Ohio State University | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Buffy Jansak, RN 614-293-7374 buffy.jansak@osumc.edu | |
Principal Investigator: Craig Hofmeister, M.D. |
Study Director: | Alison Hannah, MD | Nereus Pharmaceuticals |
Responsible Party: | Nereus Pharmaceuticals, Inc. ( Matthew A. Spear MD ) |
Study ID Numbers: | NPI-0052-101 |
Study First Received: | April 13, 2007 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00461045 History of Changes |
Health Authority: | United States: Food and Drug Administration |
multiple myeloma proteasome inhibitor |
Immunoproliferative Disorders Hemorrhagic Disorders Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders Vascular Diseases |
Paraproteinemias Lymphoproliferative Disorders Hemostatic Disorders Neoplasms, Plasma Cell Multiple Myeloma |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Blood Protein Disorders Hematologic Diseases Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |