NCT00667082|CompletedPhase 1
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Sponsor study identifier
interventional
22
1 country
3
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2010
Actual (reported)Study Completion
January 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
April 22, 2008
Actual (reported)April 25, 2008
Actual (reported)January 2010
Actual (reported)January 2010
Actual (reported)To determine the Maximum tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of the combination NPI-0052 and Vorinostat
continuously
To evaluate the pharmacokinetics and pharmacodynamics of NPI-0052 and vorinostat
continuous
To evaluate the safety and toxicity profile of the combination of NPI-0052 and vorinostat
continuous
4 dose-escalation cohorts
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Sir Charles Gairdner Hospital and University of Western Australia
Nedlands, Western Australia, 6009, Australia
Steven D Reich, MD
Triphase Research and Development I Corp
22 participants (actual enrollment reported by the registry).
First Submitted
April 22, 2008
First Posted
April 25, 2008
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
To evaluate the anti-tumor activity of NPI-0052 and vorinostat
continuous
Contact the study team to confirm eligibility.
Primary Completion
January 2010
Actual (reported)Study Completion
January 2010
Actual (reported)Last Updated
November 22, 2017
Record last verified: 2017-11
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Source: ClinicalTrials.gov.
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