Trial Outcomes & Findings for Treatment of Cancer-anorexia Using Megestrol Acetate Concentrated Suspension in Lung or Pancreatic Cancer Patients (NCT NCT00637728)

Last Updated: 2016-06-23

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

5 participants

Primary outcome timeframe

8 weeks

Results posted on

2016-06-23

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

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 Placebo Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
Double-blind Phase STARTED	4	1
Double-blind Phase COMPLETED	0	0
Double-blind Phase NOT COMPLETED	4	1
Extension Phase STARTED	0	0
Extension Phase COMPLETED	0	0
Extension Phase NOT COMPLETED	0	0

Reasons for withdrawal

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 Placebo Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase
Double-blind Phase Adverse Event	1	0
Double-blind Phase Non-compliance	2	0
Double-blind Phase Study Discontinued	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DB MA-CS 550 mg/Day n=4 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 Placebo n=1 Participants Placebo suspension administered orally q24h (5 mL dose) in the 8-week DB phase	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age, Categorical >=65 years	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=93 Participants	1 Participants n=4 Participants	5 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) White	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	4 participants n=93 Participants	1 participants n=4 Participants	5 participants n=27 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 4 and Week 8

Population: Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Population: Results not analyzed due to early termination of the study. Study was terminated early, no data were collected for this Outcome Measure.

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: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

DB Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

OL MA-CS 550 mg/Day

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DB MA-CS 550 mg/Day n=4 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 Placebo n=1 participants at risk 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 OL extension phase
Cardiac disorders Cardiac arrest	25.0% 1/4 • 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)	— 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)
Gastrointestinal disorders Oesophagitis	25.0% 1/4 • 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)	— 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)
General disorders Disease progression	25.0% 1/4 • 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)	— 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)
Infections and infestations Pneumonia aspergillus	25.0% 1/4 • 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)	— 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)
Investigations Haemoglobin decreased	25.0% 1/4 • 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)	— 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)
Metabolism and nutrition disorders Dehydration	25.0% 1/4 • 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)	— 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)
Nervous system disorders Coma	25.0% 1/4 • 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)	— 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)
Respiratory, thoracic and mediastinal disorders Respiratory failure	25.0% 1/4 • 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)	— 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)
Vascular disorders Hypotension	25.0% 1/4 • 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)	— 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)

Other adverse events

Other adverse events
Measure	DB MA-CS 550 mg/Day n=4 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 Placebo n=1 participants at risk 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 OL extension phase
Blood and lymphatic system disorders Anemia	50.0% 2/4 • Number of events 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)	— 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)
Investigations Weight decreased	0.00% 0/4 • 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)	— 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)
Renal and urinary disorders Renal failure	25.0% 1/4 • 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)	— 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)
Gastrointestinal disorders Vomiting	25.0% 1/4 • Number of events 3 • 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)	— 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)
Metabolism and nutrition disorders Dehydration	25.0% 1/4 • 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)	— 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)
Respiratory, thoracic and mediastinal disorders Dyspnoea	25.0% 1/4 • 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)	— 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)

Additional Information

M. Todd Kirby, PhD

Endo Pharmaceuticals Inc.

Phone: (484) 216-6491

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER