TerminatedPhase 3NCT00637728

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

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

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

StatusTerminated
PhasePhase 3
U.S. locations3
SponsorPar Pharmaceutical, Inc.
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

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

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

04
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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