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Sponsored by: |
Nereus Pharmaceuticals, Inc. |
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Information provided by: | Nereus Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00629473 |
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 advanced malignancies including solid tumors, lymphomas, leukemias and 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 |
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Advanced Malignancies |
Drug: NPI 0052 |
Phase I |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Malignancies |
Estimated Enrollment: | 50 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Advan. malignancies: Experimental
IV injection of NPI-0052 on Days 1, 8, 15 of 28 day cycle in patients with advanced malignancies other than multiple myeloma
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Drug: NPI 0052
IV injection on Days 1, 8, 15 of 28 day cycle
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multiple myeloma: Experimental
IV injection of NPI-0052 on Days 1, 8, 15 of 28 day cycle in patients with multiple myeloma
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Drug: NPI 0052
IV injection on Days 1, 8, 15 of 28 day cycle
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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 |
Australia, Queensland | |
Mater Adult Hospital | Recruiting |
South Brisbane, Queensland, Australia, 4101 | |
Contact: Ken Musgrave, RN +61 7 3163 6731 Ken.Musgrave@mater.org.au | |
Principal Investigator: Paul Mainwaring, MD | |
Sub-Investigator: Lawrence Catley, MD | |
Australia, South Australia | |
The Queen Elizabeth Hospital | Recruiting |
Woodville South, South Australia, Australia, 5001 | |
Contact: Louise Pirc, RN +61 8 8822 7411 Louise.Pirc@nwahs.sa.gov.au | |
Principal Investigator: Timothy Price, MD | |
Sub-Investigator: Amanda Townsend, MD | |
Australia, Victoria | |
The Alfred Hospital | Recruiting |
Melbourne, Victoria, Australia, 3168 | |
Contact: Nola Kennedy + 61 3 9076 2217 n.kennedy@alfred.org.au | |
Principal Investigator: Andrew Spencer, Assoc Prof | |
Australia, Western Australia | |
Sir Charles Gairdner Hospital and University of Western Australia | Recruiting |
Nedlands, Western Australia, Australia, 6009 | |
Contact: Judy Innes-Rowe, RN +61 8 9346 4520 judy.innes-row@health.wa.gov.au | |
Principal Investigator: Michael Millward, Professor | |
Estonia | |
Tartu University Hospital Oncology | Recruiting |
Tartu, Estonia, 51003 | |
Contact: Kristi Saar +372 731 9800 kristi.saar@klinikum.ee | |
Principal Investigator: Peeter Padrik, MD | |
Tallinn Cancer Center | Recruiting |
Tallinn, Estonia, 10167 | |
Contact: Sille Reinumae +372 675 5290 sillerei@gmail.com | |
Principal Investigator: Andrus Magi, MD |
Study Director: | Matthew A Spear, MD | Nereus Pharmaceuticals, Chief Medical Officer |
Responsible Party: | Nereus Pharmaceuticals, Inc ( Matthew A. Spear MD, Chief Medical Officer ) |
Study ID Numbers: | NPI 0052-102 |
Study First Received: | February 26, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00629473 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
solid tumors multiple myeloma leukemias (inc. CLL) lymphomas advanced malignancies without standard treatment options |
Leukemia Multiple myeloma Lymphoma Neoplasms, Plasma Cell Multiple Myeloma |
Neoplasms |