April 13, 2007 |
November 20, 2008 |
March 2007 |
Maximum Tolerated Dose (MTD) [ Time Frame: Continous ] [ Designated as safety issue: Yes ] |
Same as current |
Complete list of historical versions of study NCT00461045 on ClinicalTrials.gov Archive Site |
- safety and toxicity profile [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
- pharmacokinetics [ Time Frame: Continuous ] [ Designated as safety issue: No ]
- biological activity [ Time Frame: Continuous ] [ Designated as safety issue: No ]
- Recommended Phase 2 Dose [ Time Frame: Continuous ] [ Designated as safety issue: No ]
- Response (EBMT criteria) [ Time Frame: Continuous ] [ Designated as safety issue: No ]
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- safety and toxicity profile
- pharmacokinetics
- biological activity
- recommended phase 2 dose
- response (EBMT criteria)
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Phase 1 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma |
Phase 1 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma |
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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Phase I |
Interventional |
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Multiple Myeloma |
Drug: NPI-0052 |
Experimental: NPI-0052 |
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Recruiting |
35 |
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June 2009 (final data collection date for primary outcome measure) |
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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Both |
18 Years and older |
No |
Contact: Angie Longenecker, RN |
858-200-8354 |
alongenecker@nereuspharm.com |
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Contact: Matthew A Spear, M.D., Chief Medical Officer, Nereus Pharmaceuticals |
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United States |
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NCT00461045 |
Matthew A. Spear MD, Nereus Pharmaceuticals, Inc. |
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Nereus Pharmaceuticals, Inc. |
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Study Director: |
Alison Hannah, MD |
Nereus Pharmaceuticals |
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Nereus Pharmaceuticals, Inc. |
November 2008 |