Title
Regimen for the Treatment of Cachexia in Subjects With NSCLC
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
Phase
Phase 2Lead Sponsor
Vicus TherapeuticsStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
CachexiaIntervention/Treatment
etodolac propranolol ...Study Participants
37Cachexia 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.
The objective of this trial is to evaluate the safety and dose tolerability of VT-122 regimen and to evaluate the efficacy of VT-122 regimen
This trial is to be conducted on patients who have a diagnosis of Stage IV NSCLC, are not on chemotherapy, have lost 5% of their body weight in the previous 2 months and are deemed to be hypercatabolic.
VT-122 low dose, dose escalated
VT-122 high dose, dose escalated
Supportive care only
VT-122 (dose of etodolac: 400 mg/day) + supportive care
VT-122 (dose of etodolac: 800 mg/day) + supportive care
Inclusion Criteria: Subjects with NSCLC Demonstrating average weight loss of 5% within 2 months prior to enrollment Heart rate of 72 bpm or greater Negative pregnancy test (female patients of child bearing age) Able to give informed consent Able to be administered medication Able to take food and defined nutritional support Have not been on beta-blockers for a minimum of 1 week prior to administration of the medication screening dose Have not undergone surgery for at least 2 weeks prior to entry into trial Have not been on chemotherapy, immunotherapy, biologic therapy, radio therapy, and experimental therapy for a minimum of two weeks prior to medication screening dose and during their participation in this trial An expected survival for a minimum of 12 weeks Exclusion Criteria: Contraindication to nonsteroidal antiinflammatory drugs (NSAIDs) and beta blockers Blood pressure less than 100/65 Weight loss of 15% within 2 months prior to recruitment Hypersensitivity reaction to the active components in VT-122 History of myocardial infraction within the past 3 months Congestive heart failure (as determined by symptoms and ECG) A-V block of second or third degree Unstable angina Uncontrolled diabetes Unable to be assessed for grip strength A positive pregnancy test Chronic infection or sepsis History of bleeding disorders Patients with peripheral edema Patients on digoxin or other chronotropic drugs Patients with evidence of severe dehydration Patients with evidence of ascites
| Event Type | Organ System | Event Term | Group A, Control Group | Group B, Low Dose VT-122 | Group C, High Dose VT-122 |
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