Safety and Efficacy Study of Betamarc to Treat Loss of Weight and Appetite in Non-Small Cell Lung Cancer
Phase 2
Terminated
- Conditions
- AnorexiaCachexiaWeight LossCarcinoma, 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
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)
Tuen Mun Hospital
🇨🇳Hong Kong, China
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Queen Elizabeth Hospital
🇨🇳Hong Kong, China
Cathay General Hospital
🇨🇳Taipei, Taiwan
Taipei Medical University Muncipal Wan Fang Hospital
🇨🇳Taipei, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan