Regimen for the Treatment of Cachexia in Subjects With NSCLC

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vicus Therapeutics

Criteria

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