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Regimen for the Treatment of Cachexia in Subjects With NSCLC

NCT00527319 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2013-01-30

Study results available
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Summary

Cachexia is a presentation of a chronic manifestation of acute metabolic stress, a hypercatabolic nutritional state in which the normal fat and protein sparing mechanisms are not functioning and increased nutrition is not utilized.

To switch the nutritional system from a hypercatabolic to a normal nutritional state, therapy must block multi-factorial stress signaling a threshold of activation. Consistent with the synergistic hypothesis, propranolol and etodolac have been evaluated in subjects with advanced cancer demonstrating cachexia. This trial will evaluate the safety and efficacy of VT-122 in subjects with NSCLC who have hypercatabolic cachexia.

Conditions

  • Cachexia

Interventions

DRUG

VT-122 low dose

VT-122 low dose, dose escalated

DRUG

VT-122 high dose

VT-122 high dose, dose escalated

Sponsors & Collaborators

  • Vicus Therapeutics

    lead INDUSTRY

Principal Investigators

  • Richard A Guarino, MD · Oxford Pharmaceutical Resources, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-08-31
Completion
2008-09-30

Countries

  • United States
  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00527319 on ClinicalTrials.gov