Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension

Par Pharmaceutical

Status and phase: Terminated; Phase 3

Conditions: Weight Loss; Anorexia; Cachexia

Treatments: Drug: Megestrol acetate concentrated suspension 60 mg/mL; Drug: Placebo; Drug: Megestrol acetate concentrated suspension 110 mg/mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT00637806

100.2.C.005 TRANSFERRED

Details and patient eligibility

About

To compare the effect of megestrol acetate concentrated suspension and placebo on caloric intake in patients with cancer-associated anorexia.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

Megestrol acetate concentrated suspension 110 mg/mL

Treatment:

Drug: Megestrol acetate concentrated suspension 110 mg/mL

2

Active Comparator group

Description:

Megestrol acetate concentrated suspension 60 mg/mL

Treatment:

Drug: Megestrol acetate concentrated suspension 60 mg/mL

3

Placebo Comparator group

Treatment:

Drug: Placebo