View Clinical Trial (Medical Research Study)
Phase 1 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
| City: |
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Ann Arbor |
| State: |
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Michigan |
| Zip Code: |
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48109 |
| Conditions: |
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Multiple Myeloma |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Age >=18 years
- Karnofsky Performance Status (KPS) >=70%
- Histologic evidence of multiple myeloma, relapsed or relapsed/refractory disease for
which no other approved treatment is available and clinically indicated
- Adverse Events resulting from prior chemotherapy, surgery, or radiotherapy, must have
resolved to acceptable grades
- Adequate bone marrow, renal, adrenal, pancreatic and liver function
- Hemoglobin >= 8 g/dL
- Absolute neutrophil count >= 1.5 x 10^9 /L
- Platelet count >= 75 x 10^9 /L (without transfusions)
- Signed informed consent
Exclusion Criteria:
- Administration of chemotherapy, radiation, biological, immunotherapy or
investigational agent within 28 days (6 weeks for nitrosourea and 12 weeks for BMT)
- Patients may be receiving steroids or bisphosphonates, but doses must be stable
- Patients must be off intrathecal therapy for at least 3 months prior to dosing
- Ongoing coagulopathies and/or taking anticoagulants
- Patients with evidence of mucosal or internal bleeding and/or platelet refractory
- Significant cardiac disease
- Patients with a prior hypersensitivity reaction of CTCAE Grade >= 3 to therapy
containing propylene glycol or ethanol.
- Pregnant or breast-feeding women
- Significant bacterial, viral or fungal infection
- Any other medical conditions that would impose excessive risk to the patient
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| NCT ID: |
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NCT00461045 |
| Primary Contact: |
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Study Director
Alison Hannah, MD
Nereus Pharmaceuticals
Angie Longenecker, RN
Phone: 858-200-8354
Email: alongenecker@nereuspharm.com
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| Backup Contact: |
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Matthew A Spear, M.D., Chief Medical Officer, Nereus Pharmaceuticals
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| Location Contact: |
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Ann Arbor, Michigan 48109
United States
Colleen Harvey, Study Coord.
Phone: 734-936-6936
Email: ckharvey@med.umich.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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