Treatment of Cancer-anorexia Using Megestrol Acetate Concentrated Suspension in Lung or Pancreatic Cancer Patients

Study summary

Purpose of the study is to compare the effects of megestrol acetate concentrated suspension and placebo on caloric intake for the treatment of cancer-associated anorexia in patients with lung or pancreatic cancer

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedMegestrol acetate concentrated suspension 110 mg/mL and Placebo

The study team can explain what participation involves.

Who it may be forAnorexia · Cachexia

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 23, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Par Pharmaceutical, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 3
Sponsor: Par Pharmaceutical, Inc.
Interventions being studied: Drug: Megestrol acetate concentrated suspension 110 mg/mL; Drug: Placebo

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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)

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Innovative Medical Research of South Florida, IncMiami, Florida
Western Maryland Health SystemCumberland, Maryland
Lowcountry Hematology & Oncology, PAMt. Pleasant, South Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 23, 2016. Always confirm current availability with the study team.

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