Trial Outcomes & Findings for The Role of Ghrelin in Cancer Cachexia (NCT NCT01505764)
NCT ID: NCT01505764
Last Updated: 2018-07-17
Results Overview
percentage change from baseline
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
day 84
Results posted on
2018-07-17
Participant Flow
10 subjects were consented, 9 received drug or placebo, 5 completed the study.
Participant milestones
| Measure |
Arm 1 (Anamorelin HCl)
Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
|
Arm 2 (Placebo)
Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Role of Ghrelin in Cancer Cachexia
Baseline characteristics by cohort
| Measure |
Arm 1 (Anamorelin HCl)
n=6 Participants
Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
|
Arm 2 (Placebo)
n=4 Participants
Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Continuous
|
56 years
n=99 Participants
|
58 years
n=107 Participants
|
57 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
4 participants
n=107 Participants
|
10 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: day 84Population: cancer cachexia patients
percentage change from baseline
Outcome measures
| Measure |
Arm 1 (Anamorelin HCl)
n=3 Participants
Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
|
Arm 2 (Placebo)
n=2 Participants
Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
|
|---|---|---|
|
Total Body Potassium.
|
-2.13 percentage change
Standard Deviation 5.48
|
-0.72 percentage change
Standard Deviation 2.11
|
SECONDARY outcome
Timeframe: day 84Population: only two subjects in each group completed this measure.
lean body mass measured by DEXA. Percentage of change day 84-baseline.
Outcome measures
| Measure |
Arm 1 (Anamorelin HCl)
n=2 Participants
Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
|
Arm 2 (Placebo)
n=2 Participants
Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
|
|---|---|---|
|
Lean Mass Measured by Densitometry.
|
2.12 percentage change
Standard Deviation 3.05
|
-1.44 percentage change
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: day 84Population: Cancer cachexia patients
Dominant hand grip strength day 84 - percent change from baseline
Outcome measures
| Measure |
Arm 1 (Anamorelin HCl)
n=3 Participants
Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
|
Arm 2 (Placebo)
n=2 Participants
Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
|
|---|---|---|
|
Muscle Strength as Measured by Grip Strength.
|
0.31 percentage change
Standard Deviation 11.19
|
-10.45 percentage change
Standard Deviation 14.49
|
SECONDARY outcome
Timeframe: day 84Population: cancer cachexia patients
percent change from day 84-baseline
Outcome measures
| Measure |
Arm 1 (Anamorelin HCl)
n=3 Participants
Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
|
Arm 2 (Placebo)
n=2 Participants
Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
|
|---|---|---|
|
Body Weight.
|
1.7 percentage change
Standard Deviation 3.19
|
-1.8 percentage change
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: day 84Population: cancer cachexia patients
Quality of life as assessed using the FACIT-F Patient Reported Outcome assessments - percentage of change day 84-baseline
Outcome measures
| Measure |
Arm 1 (Anamorelin HCl)
n=3 Participants
Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
|
Arm 2 (Placebo)
n=2 Participants
Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
|
|---|---|---|
|
Quality of Life.
|
-6.54 percentage change
Standard Deviation 4.9
|
-14.32 percentage change
Standard Deviation 3.78
|
SECONDARY outcome
Timeframe: day 84Population: cancer cachexia patients
Appetite measured by a visual analogue scale ASAS. Percentage of change day84-baseline
Outcome measures
| Measure |
Arm 1 (Anamorelin HCl)
n=3 Participants
Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
|
Arm 2 (Placebo)
n=2 Participants
Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
|
|---|---|---|
|
Appetite.
|
8.33 percentage change
Standard Deviation 38.18
|
1.66 percentage change
Standard Deviation 25.92
|
SECONDARY outcome
Timeframe: day 84Population: cancer cachexia patients
% change between day 84 and baseline
Outcome measures
| Measure |
Arm 1 (Anamorelin HCl)
n=3 Participants
Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
|
Arm 2 (Placebo)
n=2 Participants
Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
|
|---|---|---|
|
Resting Energy Expenditure.
|
-1.02 percentage change
Standard Deviation 13.8
|
-2.58 percentage change
Standard Deviation 2.75
|
SECONDARY outcome
Timeframe: day 84Population: only two subjects in each group completed this measure.
Functional performance using stair-climbing power day 84 percent change from baseline
Outcome measures
| Measure |
Arm 1 (Anamorelin HCl)
n=2 Participants
Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
|
Arm 2 (Placebo)
n=2 Participants
Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
|
|---|---|---|
|
Functional Performance.
|
22.53 percentage change
Standard Deviation 9.87
|
-13.8 percentage change
Standard Deviation 12.36
|
SECONDARY outcome
Timeframe: day 84Population: only two subjects in each group completed this outcome
Body composition as measured by Total body nitrogen. Percentage of change day 84-baseline
Outcome measures
| Measure |
Arm 1 (Anamorelin HCl)
n=2 Participants
Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
|
Arm 2 (Placebo)
n=2 Participants
Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
|
|---|---|---|
|
Body Composition.
|
-5.7 percentage change
Standard Deviation 3.4
|
6.31 percentage change
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: day 84Population: only two subjects in each group completed this outcome
Percent change from baseline
Outcome measures
| Measure |
Arm 1 (Anamorelin HCl)
n=2 Participants
Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
|
Arm 2 (Placebo)
n=2 Participants
Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
|
|---|---|---|
|
Stair Climbing Power
|
-30.39 percentage change
Standard Deviation 27.86
|
4.12 percentage change
Standard Deviation 15.23
|
SECONDARY outcome
Timeframe: day 84Population: only two subjects in each group completed this outcome
leg extension - percentage of change day 84 to baseline
Outcome measures
| Measure |
Arm 1 (Anamorelin HCl)
n=2 Participants
Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
|
Arm 2 (Placebo)
n=2 Participants
Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
|
|---|---|---|
|
1-repetition Max. Strength
|
93.87 percentage change
Standard Deviation 70.53
|
-8.29 percentage change
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: day 84Population: cancer cachexia patients
change between day 84 and baseline
Outcome measures
| Measure |
Arm 1 (Anamorelin HCl)
n=3 Participants
Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
|
Arm 2 (Placebo)
n=2 Participants
Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
|
|---|---|---|
|
Food Diary Calorie Count
|
-21 percentage change
Standard Deviation 14
|
-12 percentage change
Standard Deviation 19
|
Adverse Events
Arm 1 (Anamorelin HCl)
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm 2 (Placebo)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 (Anamorelin HCl)
n=6 participants at risk
Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
|
Arm 2 (Placebo)
n=4 participants at risk
Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
neoplasm progression
|
33.3%
2/6 • Number of events 2
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
anemia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
Other adverse events
| Measure |
Arm 1 (Anamorelin HCl)
n=6 participants at risk
Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
|
Arm 2 (Placebo)
n=4 participants at risk
Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
|
|---|---|---|
|
Nervous system disorders
pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
|
Nervous system disorders
fatigue
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
chest pain
|
0.00%
0/6
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
16.7%
1/6 • Number of events 1
|
0.00%
0/4
|
Additional Information
Jose M Garcia MD, PhD, Clinician Investigator
Department of Veterans Affairs
Phone: 206-7642984
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place