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Difficulty finding the required patient population
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| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Megestrol acetate concentrated suspension 110 mg/mL |
|
| 2 | Placebo Comparator | Placebo suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Weight Over the Course of the 8-week Double-blind Phase | Baseline, Week 1, 2, 3, 4, 6, and 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynn D Kramer, MD | Par Pharmaceutical, Inc. | Study Chair |
| John N Mehanna, MD | Western Maryland Health System | Principal Investigator |
| M.Daud Nawabi, MD | Lowcountry Hematology & Oncology, PA | Principal Investigator |
| Marc A Saltzman, MD | Innovative Medical Research of South Florida, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovative Medical Research of South Florida, Inc | Miami | Florida | 33179 | United States | ||
| Western Maryland Health System |
After screening, eligible subjects were randomized to treatment in the double-blind phase. After completing the double-blind phase or discontinuing due to specific weight loss criteria, eligible subjects could enter an open-label extension phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | DB MA-CS 550 mg/Day | Megestrol acetate concentrated suspension (MA-CS; 110 mg/mL) administered orally once every 24 hours (q24h), for a daily dose of 550 mg per day (5 mL dose) in the 8-week double-blind (DB) phase |
| FG001 | DB Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind Phase |
|
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|
| Placebo | Drug | Placebo oral suspension, 5 mL once daily |
|
| Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale | Subjects marked 6 items on a visual analog scale (VAS) appetite scale including feeling not hungry to hungry, not nauseated to nauseated, empty to full, not satiated to satiated; weak to strong desire to eat; and ability to eat none to a large amount of food | Baseline, Weeks 1, 2, 3, 4, 6 and 8 |
| Cumberland |
| Maryland |
| 21502 |
| United States |
| Lowcountry Hematology & Oncology, PA | Mt. Pleasant | South Carolina | 29464 | United States |
Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase |
| FG002 | OL MA-CS 550 mg/Day | MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week open-label (OL) extension phase |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Extension Phase |
|
All subjects who received at least 1 dose of study medication and who had at least 1 on-therapy safety assessment
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| ID | Title | Description |
|---|---|---|
| BG000 | DB MA-CS 550 mg/Day | MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase |
| BG001 | DB Placebo | Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure. | Posted | 8 weeks |
|
| ||||||||||||||||||||||
| Secondary | Changes in Body Composition as Measured by Bioelectric Impedance Analysis (BIA) at Week 4 and Week 8 Relative to Baseline | Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure. | Posted | Baseline, Week 4 and Week 8 |
|
| |||||||||||||||||||||||
| Secondary | Change in Weight Over the Course of the 8-week Double-blind Phase | Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure. | Posted | Baseline, Week 1, 2, 3, 4, 6, and 8 |
|
| |||||||||||||||||||||||
| Secondary | Change in Appetite Over the 8-week Double-blind Phase as Measured by a VAS Appetite Scale | Subjects marked 6 items on a visual analog scale (VAS) appetite scale including feeling not hungry to hungry, not nauseated to nauseated, empty to full, not satiated to satiated; weak to strong desire to eat; and ability to eat none to a large amount of food | Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure. | Posted | Baseline, Weeks 1, 2, 3, 4, 6 and 8 |
|
|
Approximately 98 days (from informed consent through 7 days following the last dose of study drug or up until the last protocol-specified study visit, whichever occurred later)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DB MA-CS 550 mg/Day | MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 8-week DB phase | 2 | 4 | 3 | 4 | ||
| EG001 | DB Placebo | Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase | 0 | 1 | 1 | 1 | ||
| EG002 | OL MA-CS 550 mg/Day | MA-CS (110 mg/mL) administered orally q24h, for a daily dose of 550 mg per day (5 mL dose) in the 4-week OL extension phase | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Pneumonia aspergillus | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 8.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M. Todd Kirby, PhD | Endo Pharmaceuticals Inc. | (484) 216-6491 | kirby.todd@endo.com |
| ID | Term |
|---|---|
| D000855 | Anorexia |
| D002100 | Cachexia |
| D015431 | Weight Loss |
| D008175 | Lung Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D013851 | Thinness |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D019290 | Megestrol Acetate |
| ID | Term |
|---|---|
| D008535 | Megestrol |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|