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NCT Number: NCT00667082

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Blood Protein Disorders Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Cardiovascular Diseases Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Melanoma Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplasms, Plasma Cell Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Paraproteinemias Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royal Adelaide Hospital, Adelaide, South Australia, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Karnofsky Performance Status (KPS) at 70% or more.
  • 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.
  • 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).
  • Adequate bone marrow, renal, liver function.
  • Signed informed consent.

Exclusion criteria

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

Treatment and study plan

NPI-0052 (marizomib) + vorinostat

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 25, 2008
Registry last updated
Nov 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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