drugset / Trial / NCT00527319

Regimen for the Treatment of Cachexia in Subjects With NSCLC

NCT00527319

Phase 2 Completed 37 enrolled Vicus Therapeutics
RandomizedFactorialOpen-labelSupportive care

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.

Timeline

Start
2007-01
Primary completion
2008-08
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Propranolol Small molecule 400 mg
Comparator Propranolol Small molecule 800 mg