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

Inclusion Criteria:

- Cancer of multiple types in stage II, III, or IV and not a candidate for
chemotherapy; but may have been receiving radiation therapy

- Fair, poor, or very poor appetite

- Cancer-associated anorexia/cachexia (documented weight loss of 2% over the prior
week, or at least 5% within past 30 days, or at least 7.5% over prior 3 months, or at
least 10% over prior 6 months)

- Weight loss perceived to be associated with diminished appetite

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

- Life expectancy greater than 3 months

- Alert and mentally competent to complete study assessments

- 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 tumors that may interfere with food consumption

- AIDS-related wasting

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

- Presence of conditions that interfere with oral intake or ability to swallow

- Absence of normally functioning gut

- Known mechanical obstruction of the alimentary or biliary tract, or malabsorption
syndrome

- Intractable or frequent vomiting

- Clinically significant diarrhea

- History of thromboembolic events, or on long-term anticoagulation for thromboembolism

- Uncontrolled diabetes mellitus, or symptomatic hypoadrenalism

- Poorly controlled hypertension or congestive heart failure

- Pregnant/lactating females, or planning on becoming pregnant

- Use of appetite stimulants within past 30 days

- Use of parenteral nutrition or tube feedings within past 1 week

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

- Current use of illicit substances

- Allergy, hypersensitivity, or other contraindication to megestrol acetate