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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Triphase Research and Development I Corporation
ClinicalTrials.gov Identifier:
NCT00667082
First received: April 22, 2008
Last updated: August 11, 2014
Last verified: August 2014
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
  • To evaluate the pharmacokinetics and pharmacodynamics of NPI-0052 and vorinostat [ Time Frame: continuous ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety and toxicity profile of the combination of NPI-0052 and vorinostat [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
  • To evaluate the anti-tumor activity of NPI-0052 and vorinostat [ Time Frame: continuous ] [ Designated as safety issue: No ]

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: single arm study Drug: NPI-0052 (marizomib) + vorinostat
NPI-0052 IV weekly vorinostat oral daily
Other Names:
  • Marizomib
  • proteasome inhibitor
  • HDAC inhibitor
  • Zolinza

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Triphase Research and Development I Corporation
ClinicalTrials.gov Identifier: NCT00667082     History of Changes
Other Study ID Numbers: NPI-0052-103
Study First Received: April 22, 2008
Last Updated: August 11, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Triphase Research and Development I Corporation:
Non small Cell Lung Cancer
Pancreatic Cancer
Melanoma
Lymphoma
Multiple Myeloma

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

ClinicalTrials.gov processed this record on September 18, 2014