Clinical Trials Directory

Trials / Completed

CompletedNCT00667082

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
22 (actual)
Sponsor
Celgene · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGNPI-0052 (marizomib) + vorinostatNPI-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

Timeline

Start date
2008-03-01
Primary completion
2010-01-01
Completion
2010-01-01
First posted
2008-04-25
Last updated
2017-11-22

Locations

3 sites across 1 country: Australia

Source: ClinicalTrials.gov record NCT00667082. Inclusion in this directory is not an endorsement.