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Phase 1 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
This study is currently recruiting participants.
Verified by Nereus Pharmaceuticals, Inc., November 2008
First Received: April 13, 2007   Last Updated: November 20, 2008   History of Changes
Sponsored by: Nereus Pharmaceuticals, Inc.
Information provided by: Nereus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00461045
  Purpose

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

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
U.S. FDA Resources
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

Further study details as provided by Nereus Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: Continous ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00461045

Contacts
Contact: Angie Longenecker, RN 858-200-8354 alongenecker@nereuspharm.com
Contact: Matthew A Spear, M.D., Chief Medical Officer, Nereus Pharmaceuticals

Locations
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.            
Sponsors and Collaborators
Nereus Pharmaceuticals, Inc.
Investigators
Study Director: Alison Hannah, MD Nereus Pharmaceuticals
  More Information

No publications provided

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

Keywords provided by Nereus Pharmaceuticals, Inc.:
multiple myeloma
proteasome inhibitor

Study placed in the following topic categories:
Immunoproliferative Disorders
Hemorrhagic Disorders
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 06, 2009