Safety and Efficacy Study of Betamarc to Treat Loss of Weight and Appetite in Non-Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Betamarc is effective in improving the appetite and reversing weight loss in patients with advanced Non-Small Cell Lung Cancer.

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

Details

• Lead Sponsor: Anaborex

Criteria

Inclusion Criteria:

• Newly diagnosed Stage IIIB or IV non-resectable NSCLC. Recurrent disease after resection for earlier stage disease is acceptable as long as patients are at least 6 months from surgery.

• Treatment plan includes a platinum-based doublet chemotherapy.

• ECOG 0, 1 or 2.

• Self-reported loss of body weight or anorexia.

• Serum C-reactive protein ≥5 mg/L.

• Life expectancy of at least 6 months.

• Adequate bone marrow, liver and renal function.

• Normal serum potassium.

• Ability to comply with the study requirements and give written informed consent.

Exclusion Criteria:

• Known physical or functional obstruction of the gastrointestinal tract, malabsorption, intractable vomiting, uncontrollable diarrhea, concurrently receiving tube feeding or parenteral nutrition, or unable to swallow investigational drug product.

• Concomitant therapy with an appetite stimulant.

• History of poorly controlled hypertension or congestive heart failure.

• Any implanted devices that could interfere with DXA scanning.

• Prolongation of QT interval.

• History of additional risk factors for torsades de pointe.

• Concomitant therapy with beta-adrenergic receptor antagonists (beta-blockers) or ergot derivatives.

• Females who are breast feeding, pregnant or of child-bearing potential who are not using adequate birth control.

• Any second malignancy which might confound the interpretation of safety or efficacy assessments.

• Any condition which increases the patient's risk for participating in the study.