Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension

NCT00637806 | Terminated Phase 3 Results

• 1 other identifier: 100.2.C.005 TRANSFERRED
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Anorexia; Cachexia; Weight Loss

Keywords

Megestrol acetate; Anorexia; Cachexia; Cancer; Unintended weight loss; Body weight; Appetite; Megace ES

Outcome Measures

Primary Outcomes (1)

• Average Daily Caloric Intake Over the Course of the 8-week Double-blind Phase

  The Nutrition Data System for Research (NDSR) was used to determine nutrient and caloric value for foods and beverages consumed and recorded by subjects over a 3-day assessment period prior to each visit. Total number of calories consumed during each 3-day assessment was averaged over available values to determine the week's daily caloric intake value.

  8 weeks

Secondary Outcomes (3)

• Change in Weight Over the Course of the 8-week Double-blind Phase

  Baseline, Week 1, 2, 3, 4, 6, and 8

• Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline

  Baseline, Week 4 and Week 8

• Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale

  Baseline, Weeks 1, 2, 3, 4, 6 and 8

Study Arms (3)

1

ACTIVE COMPARATOR

Megestrol acetate concentrated suspension 110 mg/mL

Drug: Megestrol acetate concentrated suspension 110 mg/mL

2

ACTIVE COMPARATOR

Megestrol acetate concentrated suspension 60 mg/mL

Drug: Megestrol acetate concentrated suspension 60 mg/mL

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Megestrol acetate concentrated suspension 110 mg/mL DRUG

Megestrol acetate concentrated suspension 110 mg/mL given as an oral dose of 550 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase

Also known as: Megace ES

1

Megestrol acetate concentrated suspension 60 mg/mL DRUG

Megestrol acetate concentrated suspension 60 mg/mL given as an oral dose of 300 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase

Also known as: Megace ES

2

Placebo DRUG

Placebo oral suspension, 5 mL once daily

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Par Pharmaceutical, Inc.: lead
• PRA Health Sciences: collaborator

Study Sites (4)

Pacific Cancer Medical Center, Inc.

Anaheim, California, 92801, United States

Location

Four Seasons Hospice and Paliative Care

Flat Rock, North Carolina, 28731, United States

Location

Wake Forest University

High Point, North Carolina, 27262, United States

Location

Summit Oncology Associates, Inc.

Akron, Ohio, 44304, United States

Location

MeSH Terms

Conditions

Anorexia; Cachexia; Weight Loss; Neoplasms; Body Weight

Interventions

Megestrol Acetate

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Thinness

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: M. Todd Kirby, PhD
• Organization: Endo Pharmaceuticals Inc.

kirby.todd@endo.com

(484) 216-6491

Study Officials

• Lynn D Kramer, MD

  Par Pharmaceutical, Inc.

  STUDY CHAIR

• Janet Bull, MD

  Four Seasons Hospice and Paliative Care

  PRINCIPAL INVESTIGATOR

• Veena Charu, MD

  Pacific Cancer Medical Center, Inc.

  PRINCIPAL INVESTIGATOR

• Bart Frizzell, MD

  Wake Forest University, Dept of Radiation Oncology

  PRINCIPAL INVESTIGATOR

• Mehool Patel, MD

  Summit Oncology Associates, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 18, 2008
• Study Start: June 1, 2006
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: May 2, 2016
• Results First Posted: May 2, 2016

Record last verified: 2016-03

Locations

US (4)