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Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Solid Tumor Malignancies or Refractory Lymphoma
This study is currently recruiting participants.
Verified by Nereus Pharmaceuticals, Inc., September 2008
Sponsored by: Nereus Pharmaceuticals, Inc.
Information provided by: Nereus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00396864
  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 refractory solid tumors or lymphomas. 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
Cancer
Solid Tumors
Lymphomas
Drug: NPI-0052
Phase I

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Solid Tumor Malignancies or Refractory Lymphoma

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

Primary Outcome Measures:
  • Safety [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
  • Maximum Tolerated Dose (MTD) [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: Continuous ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamics [ Time Frame: Continuous ] [ Designated as safety issue: No ]
  • Response [ Time Frame: Continous ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2006
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Advanced Solid Tumor Malignancies and Refractory Lymphoma
Drug: NPI-0052
IV injection, three times every 28 days, escalating dosing cohorts

  Eligibility

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

Inclusion Criteria:

  • Histologically-confirmed solid tumor malignancy (patients must be refractory to or demonstrate unacceptable toxicity towards effective therapy known to provide clinical benefit for their condition) OR refractory lymphoma (patients whose disease has progressed despite standard therapy including at least one-doxorubicin-containing regimen and one anti-CD20 monoclonal antibody-containing regimen.
  • KPS ≥70%.
  • All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to NCI CTCAE (v. 3.0) Grade ≤ 1 (except for hemoglobin).
  • Adequate bone marrow, renal, adrenal, pancreatic and liver function.
  • Signed informed consent.

Exclusion Criteria:

  • Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 28 days prior to receipt of study medication (6 weeks for nitrosoureas or mitomycin C; 12 weeks for radioimmunotherapy). Major surgery, other than diagnostic surgery, within 4 weeks before first study drug administration. Radiotherapy within 4 weeks.
  • Patients that require G-CSF and/or platelet support.
  • Patients with ongoing coagulopathies.
  • Patients with prior bone marrow transplant therapy (autologous or allogeneic).
  • Patients receiving intrathecal therapy.
  • Known brain metastases.
  • 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. Female patients must be postmenopausal, surgically sterile or they must agree to use acceptable methods of birth control. Female patients with childbearing potential must have a negative serum pregnancy test. Male patients must be surgically sterile or agree to use an acceptable method of contraception.
  • Concurrent, active secondary malignancy for which the patient is receiving therapy.
  • Active uncontrolled bacterial or fungal infection requiring systemic therapy; infection requiring parenteral antibiotics.
  • Known to be positive for HIV; active hepatitis A, B, or C infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396864

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, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Michelle Maziarz     646-227-2125        
Principal Investigator: Carol Aghajanian, M.D.            
Sub-Investigator: Paul Hamlin, M.D.            
United States, Texas
Univ. of Texas MD Anderson Cancer Center Recruiting
Houston,, Texas, United States, 77030
Contact: Debra Williams     713-792-1871        
Principal Investigator: Razelle Kurzrock, M.D.            
Sub-Investigator: Anas Younes, M.D.            
Sponsors and Collaborators
Nereus Pharmaceuticals, Inc.
Investigators
Study Director: Alison Hannah, M.D. Nereus Pharmaceuticals
  More Information

Responsible Party: Nereus Pharmaceuticals, Inc. ( Matthew A. Spear MD/Chief Medical Officer )
Study ID Numbers: NPI-0052-100
Study First Received: November 6, 2006
Last Updated: September 24, 2008
ClinicalTrials.gov Identifier: NCT00396864  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009