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

Phase 2

Terminated

• Conditions: Anorexia; Cachexia; Weight Loss; Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT00535015
• Lead Sponsor: Anaborex

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-23
• Study First Submitted QC: 2007-09-23
• Study First Posted: 2007-09-26
• Study Start: 2007-10
• Primary Completion: 2008-06
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-19
• Last Update Posted: 2008-07-22
• Study Completion: 2008-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional capacity (strength and endurance), body composition by DXA, inflammation, patient reported outcomes, anti-tumor response rate	25 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse events, ECG, vital signs, clinical laboratory parameters and physical examination	25 weeks

Trial Locations

Locations (6)

Queen Elizabeth Hospital; 🇨🇳 Hong Kong, China

Tuen Mun Hospital; 🇨🇳 Hong Kong, China

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

Cathay General Hospital; 🇨🇳 Taipei, Taiwan

Taipei Medical University Muncipal Wan Fang Hospital; 🇨🇳 Taipei, Taiwan