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Phase 1 Clinical Trial in Patients With Advanced Malignancies
This study is currently recruiting participants.
Verified by Nereus Pharmaceuticals, Inc., November 2008
Sponsored by: Nereus Pharmaceuticals, Inc.
Information provided by: Nereus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00629473
  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 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
Advanced Malignancies
Drug: NPI 0052
Phase I

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma
U.S. FDA Resources
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

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

Primary Outcome Measures:
  • To determine Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of NPI 0052 when administered via IV injection on Days 1, 8, 15 during a four week cycle for patients with advanced malignancies [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the pharmacokinetics, toxicity profile, biological activity, pharmacodynamics and anti-tumor activity of NPI-0052 in patients with these malignancies. [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]

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
Drug: NPI 0052
IV injection on Days 1, 8, 15 of 28 day cycle
multiple myeloma: Experimental
IV injection of NPI-0052 on Days 1, 8, 15 of 28 day cycle in patients with multiple myeloma
Drug: NPI 0052
IV injection on Days 1, 8, 15 of 28 day cycle

  Eligibility

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

Inclusion Criteria:

  • Karnofsky Performance Status (KPS) > 70%.
  • Histologically-confirmed advanced malignancy for which a standard, approved therapy is not available.
  • Adequate renal, liver, pancreatic and hematologic function
  • Signed informed consent (sample IC form is provided in Appendix A).

Exclusion Criteria

  • Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 28 days
  • Patients that require G-CSF and/or platelet support during screening and are likely to require G-CSF and/or platelet support for the duration of the clinical trial.
  • Patients with ongoing coagulopathies and/or taking anticoagulants
  • Patients receiving intrathecal therapy.
  • Known brain metastases.
  • Pre-existing adrenal insufficiency; concomitant therapy with replacement corticosteroids. Pre-existing acute or chronic pancreatitis.
  • Significant cardiac disease.
  • Pregnant or breast-feeding women.
  • Concurrent, active secondary malignancy for which the patient is receiving therapy. (Lymphoma patients with a diagnosis of a potentially hormone-sensitive tumor who are without evidence of disease for this second malignancy may continue to receive hormonal therapy).
  • Patients with proteinuria Grade 2 or greater
  • Active uncontrolled bacterial or fungal infection requiring systemic therapy; infection requiring parenteral antibiotics.
  • Patients who are known to be HIV positive or have active Hepatitis A, B, or C infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629473

Contacts
Contact: Angie Longenecker, RN (858) 200-8354 alongenecker@nereuspharm.com

Locations
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            
Sponsors and Collaborators
Nereus Pharmaceuticals, Inc.
Investigators
Study Director: Matthew A Spear, MD Nereus Pharmaceuticals, Chief Medical Officer
  More Information

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

Keywords provided by Nereus Pharmaceuticals, Inc.:
solid tumors
multiple myeloma
leukemias (inc. CLL)
lymphomas
advanced malignancies without standard treatment options

Study placed in the following topic categories:
Leukemia
Multiple myeloma
Lymphoma
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009