We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00667082
First Posted: April 25, 2008
Last Update Posted: October 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Triphase Research and Development I Corporation
  Purpose
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 Intervention Phase
Non-Small Cell Lung Cancer Pancreatic Cancer Melanoma Lymphoma Multiple Myeloma Drug: NPI-0052 (marizomib) + vorinostat Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: NPI-0052 and Vorinostat in Patients With Non-small Cell Lung Cancer, Pancreatic Cancer, Melanoma or Lymphoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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:
  • To evaluate the pharmacokinetics and pharmacodynamics of NPI-0052 and vorinostat [ Time Frame: continuous ]
  • To evaluate the safety and toxicity profile of the combination of NPI-0052 and vorinostat [ Time Frame: continuous ]
  • To evaluate the anti-tumor activity of NPI-0052 and vorinostat [ Time Frame: continuous ]

Enrollment: 22
Study Start Date: March 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
  Contacts and Locations
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
Triphase Research and Development I Corporation
Investigators
Study Director: Steven D Reich, MD Triphase Research and Development I Corp
  More Information

Responsible Party: Triphase Research and Development I Corporation
ClinicalTrials.gov Identifier: NCT00667082     History of Changes
Other Study ID Numbers: NPI-0052-103
First Submitted: April 22, 2008
First Posted: April 25, 2008
Last Update Posted: October 3, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Triphase Research and Development I Corporation:
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