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

Anaborex

Status and phase

Terminated

Phase 2

Conditions

Weight Loss

Anorexia

Carcinoma, Non-Small-Cell Lung

Cachexia

Treatments

Drug: Betamarc

Study type

Interventional

Funder types

Industry

Identifiers

NCT00535015

ANA-CTP0002

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.