Trial Outcomes & Findings for Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension (NCT NCT00637806)
NCT ID: NCT00637806
Last Updated: 2016-05-02
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
4 participants
Primary outcome timeframe
8 weeks
Results posted on
2016-05-02
Participant Flow
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.
Participant milestones
| Measure |
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
|
DB MA-CS 300 mg/Day
MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
|
DB Placebo
Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
|
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
|
|---|---|---|---|---|
|
Double-blind Phase
STARTED
|
2
|
0
|
2
|
0
|
|
Double-blind Phase
COMPLETED
|
0
|
0
|
1
|
0
|
|
Double-blind Phase
NOT COMPLETED
|
2
|
0
|
1
|
0
|
|
Extension Phase
STARTED
|
0
|
0
|
0
|
1
|
|
Extension Phase
COMPLETED
|
0
|
0
|
0
|
0
|
|
Extension Phase
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
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
|
DB MA-CS 300 mg/Day
MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
|
DB Placebo
Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
|
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
|
|---|---|---|---|---|
|
Double-blind Phase
Study Discontinued
|
2
|
0
|
1
|
0
|
|
Extension Phase
Study Discontinued
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Treatment of Cancer-associated Anorexia Using Megestrol Acetate Concentrated Suspension
Baseline characteristics by cohort
| Measure |
DB MA-CS 550 mg/Day
n=2 Participants
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
|
DB MA-CS 300 mg/Day
MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
|
DB Placebo
n=2 Participants
Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
1 participants
n=99 Participants
|
—
|
2 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Gender
Female
|
1 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Gender
Male
|
1 participants
n=99 Participants
|
—
|
2 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 participants
n=99 Participants
|
—
|
2 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 participants
n=99 Participants
|
—
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
2 participants
n=99 Participants
|
—
|
1 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
—
|
2 participants
n=206 Participants
|
4 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Results not analyzed due to early termination of the study
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4, 6, and 8Population: Results not analyzed due to early termination of the study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 8Population: Results not analyzed due to early termination of the study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 6 and 8Population: Results not analyzed due to early termination of the study
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
Outcome measures
Outcome data not reported
Adverse Events
DB MA-CS 550 mg/Day
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
DB MA-CS 300 mg/Day
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DB Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
OL MA-CS 550 mg/Day
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB MA-CS 550 mg/Day
n=2 participants at risk
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
|
DB MA-CS 300 mg/Day
MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
|
DB Placebo
n=2 participants at risk
Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
|
OL MA-CS 550 mg/Day
n=1 participants at risk
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
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Accident at home
|
0.00%
0/2 • 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)
|
—
0/0 • 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)
|
0.00%
0/2 • 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)
|
100.0%
1/1 • Number of events 1 • 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)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/2 • 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)
|
—
0/0 • 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)
|
0.00%
0/2 • 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)
|
100.0%
1/1 • Number of events 1 • 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)
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/2 • 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)
|
—
0/0 • 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)
|
0.00%
0/2 • 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)
|
100.0%
1/1 • Number of events 1 • 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)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/2 • 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)
|
—
0/0 • 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)
|
50.0%
1/2 • Number of events 1 • 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)
|
0.00%
0/1 • 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)
|
Other adverse events
| Measure |
DB MA-CS 550 mg/Day
n=2 participants at risk
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
|
DB MA-CS 300 mg/Day
MA-CS (60 mg/mL) administered orally q24h, for a daily dose of 300 mg per day (5 mL dose) in the 8-week DB phase
|
DB Placebo
n=2 participants at risk
Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
|
OL MA-CS 550 mg/Day
n=1 participants at risk
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
|
|---|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • 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)
|
—
0/0 • 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)
|
50.0%
1/2 • Number of events 1 • 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)
|
100.0%
1/1 • Number of events 1 • 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)
|
|
General disorders
Chest pain
|
0.00%
0/2 • 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)
|
—
0/0 • 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)
|
50.0%
1/2 • Number of events 1 • 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)
|
100.0%
1/1 • Number of events 1 • 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)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • 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)
|
—
0/0 • 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)
|
50.0%
1/2 • Number of events 1 • 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)
|
100.0%
1/1 • Number of events 1 • 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)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • 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)
|
—
0/0 • 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)
|
50.0%
1/2 • Number of events 1 • 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)
|
0.00%
0/1 • 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)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/2 • 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)
|
—
0/0 • 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)
|
50.0%
1/2 • Number of events 1 • 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)
|
0.00%
0/1 • 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)
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Number of events 1 • 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)
|
—
0/0 • 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)
|
0.00%
0/2 • 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)
|
0.00%
0/1 • 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)
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • 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)
|
—
0/0 • 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)
|
0.00%
0/2 • 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)
|
0.00%
0/1 • 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)
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • 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)
|
—
0/0 • 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)
|
0.00%
0/2 • 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)
|
0.00%
0/1 • 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)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER