Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Solid Tumor Malignancies or Refractory Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Triphase Research and Development I Corporation
ClinicalTrials.gov Identifier:
NCT00396864
First received: November 6, 2006
Last updated: August 11, 2014
Last verified: August 2014
  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
Lymphomas
Drug: NPI-0052
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Solid Tumor Malignancies or Refractory Lymphoma

Resource links provided by NLM:


Further study details as provided by Triphase Research and Development I Corporation:

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 ]

Enrollment: 51
Study Start Date: May 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Advanced Solid Tumor Malignancies and Refractory Lymphoma
Drug: NPI-0052
IV injection, three times every 28 days, escalating dosing cohorts
Other Name: Marizomib

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396864

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Texas
Univ. of Texas MD Anderson Cancer Center
Houston,, Texas, United States, 77030
Sponsors and Collaborators
Triphase Research and Development I Corporation
Investigators
Study Director: Steven D Reich, MD Triphase Research and Development I Corp
  More Information

No publications provided

Responsible Party: Triphase Research and Development I Corporation
ClinicalTrials.gov Identifier: NCT00396864     History of Changes
Obsolete Identifiers: NCT00385814
Other Study ID Numbers: NPI-0052-100
Study First Received: November 6, 2006
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Triphase Research and Development I Corporation:
cutaneous lymphoma
marginal zone lymphoma

Additional relevant MeSH terms:
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 21, 2014