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NPI-0052 and Vorinostat in Patients With Non-small Cell Lung Cancer, Pancreatic Cancer, Melanoma or Lymphoma

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ClinicalTrials.gov Identifier: NCT00667082
Recruitment Status : Completed
First Posted : April 25, 2008
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
This is a clinical trial examining the safety, pharmacokinetics, pharmacodynamics and efficacy of IV NPI-0052 (a proteasome inhibitor) in combination with oral vorinostat (Zolinza; a HDAC inhibitor) in patients with non-small cell lung cancer, pancreatic cancer, melanoma or lymphoma. Proteasome inhibitors block the breakdown of proteins by cells and HDAC inhibitors block modification of proteins regulating gene expression in cells. Both of these actions preferentially affect cancer cells, and the combination of the two has been seen to have a greater effect in laboratory studies.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Pancreatic Cancer Melanoma Lymphoma Multiple Myeloma Drug: NPI-0052 (marizomib) + vorinostat Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: NPI-0052 and Vorinostat in Patients With Non-small Cell Lung Cancer, Pancreatic Cancer, Melanoma or Lymphoma
Study Start Date : March 2008
Primary Completion Date : January 2010
Study Completion Date : January 2010


Arm Intervention/treatment
Experimental: NPI-0052 + Vorinostat Dose-Escalation
4 dose-escalation cohorts
Drug: NPI-0052 (marizomib) + vorinostat

NPI-0052 IV injection over 1 to 10 minutes at doses ranging from 0.15 to 0.7 mg/m2 on Days 1, 8, and 15 of each 28-day Cycle

Oral vorinostat 300 mg was administered with food on Days 1 to 16 of each 28-day Cycle

Other Names:
  • marizomib
  • proteasome inhibitor
  • HDAC inhibitor
  • Zolinza



Primary Outcome Measures :
  1. To determine the Maximum tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of the combination NPI-0052 and Vorinostat [ Time Frame: continuously ]

Secondary Outcome Measures :
  1. To evaluate the pharmacokinetics and pharmacodynamics of NPI-0052 and vorinostat [ Time Frame: continuous ]
  2. To evaluate the safety and toxicity profile of the combination of NPI-0052 and vorinostat [ Time Frame: continuous ]
  3. To evaluate the anti-tumor activity of NPI-0052 and vorinostat [ Time Frame: continuous ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Karnofsky Performance Status (KPS) at 70% or more.
  2. Non-small cell lung cancer, pancreatic adenocarcinoma, melanoma or lymphoma for which a standard, approved therapy is not available. Patients must have lesions that are evaluable by RECIST criteria.
  3. All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to CTCAE (v. 3.0) Grade 1 or less(except for hemoglobin).
  4. Adequate bone marrow, renal, liver function.
  5. Signed informed consent.

Exclusion Criteria:

  1. Recent administration of chemotherapy, biological, immunotherapy or investigational agent, major surgery, or radiotherapy.
  2. Intrathecal therapy.
  3. Known brain metastases.
  4. Significant cardiac disease.
  5. Prior treatment with vorinostat or NPI-0052, or other HDACi (including valproic acid) or proteasome inhibitors.
  6. Known allergy to any component of vorinostat. Prior hypersensitivity reaction of CTCAE Grade > 3 to therapy containing propylene glycol or ethanol.
  7. Pregnant or breast-feeding women.
  8. Concurrent, active secondary malignancy for which the patient is receiving therapy.
  9. Significant active infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667082


Locations
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Australia, Western Australia
Sir Charles Gairdner Hospital and University of Western Australia
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Celgene
Investigators
Study Director: Steven D Reich, MD Triphase Research and Development I Corp

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00667082     History of Changes
Other Study ID Numbers: NPI-0052-103
First Posted: April 25, 2008    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Celgene:
Non small Cell Lung Cancer
Pancreatic Cancer
Melanoma
Lymphoma
Multiple Myeloma

Additional relevant MeSH terms:
Lymphoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Melanoma
Multiple Myeloma
Neoplasms, Plasma Cell
Pancreatic Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders