Regimen for the Treatment of Cachexia in Subjects With NSCLC

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.

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