A Randomized, Double-Blind, Placebo-Controlled Study of Megestrol Acetate Concentrated Suspension for the Treatment of Cancer-Associated Anorexia in Subjects With Lung or Pancreatic Cancer

Inclusion Criteria:

- Stage II, III,or IV lung or pancreatic cancer

- Fair, poor, or very poor appetite

- Cancer associated anorexia/cachexia

- Weight loss perceived to be associated with diminished appetite

- Eastern Cooperative Oncology Group Performance score of 0, 1, 2

- Life expectancy >3 months

- Alert and mentally competent

- Women of child-bearing potential required to use an adequate and reliable method of
contraception. Post-menopausal women have to have been so for at least 1 year

- Screening laboratory values must not be clinically significant (some exceptions per
protocol)

Exclusion Criteria:

- Brain, or head and neck metastases that may interfere with food consumption

- AIDS-related wasting

- Radiation therapy to the head and neck, abdomen, or pelvis within past 6 weeks, or
anticipated during course of the study such that the result may interfere with food
consumption

- Conditions that interfere with oral intake, or ability to swallow

- Absence of a normally functioning gut

- Mechanical obstruction of the alimentary or biliary tract, or malabsorption syndrome

- Intractable or frequent vomiting that regularly interfere with eating

- Clinically significant diarrhea

- History of recurrent thromboembolic events, a thromboembolic event in past 3 months,
or long-term anticoagulation treatment for thromboembolism

- Uncontrolled diabetes mellitus, or symptomatic hypoadrenalism

- Poorly controlled hypertension, or congestive heart failure

- Pregnant/lactating females

- Use within past 30 days of an appetite stimulant

- Use within past week, or planned use during the study of parenteral nutrition or tube
feedings

- Chronic use of steroids within past 3 months (intermittent short-term use allowed)

- Current use of or not willing to abstain from using illicit substances

- Allergy, hypersensitivity, or contraindication to megestrol acetate