CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
VT-122 low dose +1 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • Diagnosis of non-small cell lung cancer (NSCLC)
  • Average weight loss of at least 5% within 2 months prior to enrollment
  • Heart rate of 72 bpm or greater
  • Expected survival of at least 12 weeks
Key exclusion· 14
  • Contraindication to NSAIDs or beta-blockers
  • Weight loss of 15% or greater within 2 months prior to recruitment
  • History of myocardial infarction within the past 3 months
  • Congestive heart failure

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00527319
NCT00527319Phase 2Completed

A Pilot Open Label Randomized Controlled Study to Evaluate the Dose Tolerance Safety and Efficacy of VT-122 Regimen for the Treatment of Cachexia in Subjects With Stage IV Non-Small Cell Lung Cancer

Vicus Therapeutics·interventional·Posted Sep 10, 2007·Updated Jan 30, 2013

In Brief

A Phase 2 clinical trial evaluating VT-122 low dose and VT-122 high dose for Cachexia. Completed, enrolled 37 participants across 8 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCachexia
CountriesIndia, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 10, 2007
Enrollment StartJan 1, 2007
Primary CompletionAug 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.8 years ago

Interventions

VT-122 low dosedrug

VT-122 low dose, dose escalated

VT-122 high dosedrug

VT-122 high dose, dose escalated