Trial Outcomes & Findings for Anamorelin Study for Advanced Pancreatic Cancer (NCT NCT04844970)
NCT ID: NCT04844970
Last Updated: 2025-11-17
Results Overview
Does anamorelin HCl dosed at 100mg per day vs. placebo demonstrate superiority on body weight gain and improvement in anorexia symptoms in patients undergoing first-line chemotherapy for incurable pancreatic cancer.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
25 weeks from baseline
Results posted on
2025-11-17
Participant Flow
Participant milestones
| Measure |
Anamorelin
Patients randomized to anamorelin HCL or placebo will take it daily for 24 weeks starting 3-5 days prior to chemotherapy.
Anamorelin Hydrochloride: Anamorelin HCl is an orally-active selective ghrelin receptor agonist which has shown anabolic and appetite-stimulating effects.
|
Placebo
Patients randomized to anamorelin HCL or placebo will take it daily for 24 weeks starting 3-5 days prior to chemotherapy.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Anamorelin
Patients randomized to anamorelin HCL or placebo will take it daily for 24 weeks starting 3-5 days prior to chemotherapy.
Anamorelin Hydrochloride: Anamorelin HCl is an orally-active selective ghrelin receptor agonist which has shown anabolic and appetite-stimulating effects.
|
Placebo
Patients randomized to anamorelin HCL or placebo will take it daily for 24 weeks starting 3-5 days prior to chemotherapy.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Anamorelin Study for Advanced Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Anamorelin
n=2 Participants
Patients randomized to anamorelin HCL or placebo will take it daily for 24 weeks starting 3-5 days prior to chemotherapy.
Anamorelin Hydrochloride: Anamorelin HCl is an orally-active selective ghrelin receptor agonist which has shown anabolic and appetite-stimulating effects.
|
Placebo
n=2 Participants
Patients randomized to anamorelin HCL or placebo will take it daily for 24 weeks starting 3-5 days prior to chemotherapy.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
3 Participants
n=120 Participants
|
|
Age, Continuous
|
57.5 years
n=202 Participants
|
75.5 years
n=283 Participants
|
66.5 years
n=120 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
4 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
4 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
3 Participants
n=120 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=202 Participants
|
2 participants
n=283 Participants
|
4 participants
n=120 Participants
|
PRIMARY outcome
Timeframe: 25 weeks from baselinePopulation: No patients were analyzed for this outcome measure because no weight was collected at the 25-week time point.
Does anamorelin HCl dosed at 100mg per day vs. placebo demonstrate superiority on body weight gain and improvement in anorexia symptoms in patients undergoing first-line chemotherapy for incurable pancreatic cancer.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to week 13Population: Upon review of collected data, no subjects completed the FAACT - 5 questionnaire at the week 13 visit. Three out of 4 patient were not on the study at the week 13 visit.
Absolute change in the Functional Assessment of Anorexia/Cachexia Treatment (FAACT 5) item Anorexia Symptom Score from baseline at week 13
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 25 weeksPopulation: Unable to analyze the Anamorelin group since both patients withdrew consent. One patient in the Placebo arm ended the study prior to week 13 and could not be analyzed for this outcome.
Overall Survival
Outcome measures
| Measure |
Anamorelin
Patients randomized to anamorelin HCL will take it daily for 24 weeks starting 3-5 days prior to chemotherapy.
Anamorelin Hydrochloride: Anamorelin HCl is an orally-active selective ghrelin receptor agonist which has shown anabolic and appetite-stimulating effects.
|
Placebo
n=1 Participants
Patients randomized to Placebo will take it daily for 24 weeks starting 3-5 days prior to chemotherapy.
|
|---|---|---|
|
Survival
|
—
|
1 Participants
|
SECONDARY outcome
Timeframe: from baseline to week 13Population: RECIST data was not collected for any patient at the week 13 time point and therefore not analyzed for this outcome. Three out of the 4 patients were not on the study at week 13, and one patient's RECIST data was not collected due to site error.
Chemotherapy response will be evaluated by RECIST criteria
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to week 25 (end of the study)Population: Weight was not collected for 3 out of 4 patients since they were already removed from the trial by week 25 and the fourth patients' weight was not collected due to site error.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to week 13Population: Upon review of collected data, 3 of 4 patients were no longer on the trial at week 13. The fourth patients' data was not collected.
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire, fatigue subscale
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to week 25 (end of study)Population: 2 patients on the anamorelin arm both withdrew, data was collected until withdraw of consent. One patient on the placebo arm ended the study prior to week 13 (data collected up until they ended) and another patient's data was analyzed through week 25.
expected toxicities for Chemotherapies (FOLFIRINOX and Gemcitabine/Nab-Paclitaxel) will be assessed by CTCAE v5.0
Outcome measures
| Measure |
Anamorelin
n=2 Participants
Patients randomized to anamorelin HCL will take it daily for 24 weeks starting 3-5 days prior to chemotherapy.
Anamorelin Hydrochloride: Anamorelin HCl is an orally-active selective ghrelin receptor agonist which has shown anabolic and appetite-stimulating effects.
|
Placebo
n=2 Participants
Patients randomized to Placebo will take it daily for 24 weeks starting 3-5 days prior to chemotherapy.
|
|---|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: from baseline to week 25 (end of study)Population: 2 patients on the anamorelin arm both withdrew, data was collected until withdraw of consent. One patient on the placebo arm ended the study prior to week 13 (data collected up until they ended) and another patient's data was analyzed through week 25.
Number of AEs that are definitely related to Anamorelin or Placebo.
Outcome measures
| Measure |
Anamorelin
n=2 Participants
Patients randomized to anamorelin HCL will take it daily for 24 weeks starting 3-5 days prior to chemotherapy.
Anamorelin Hydrochloride: Anamorelin HCl is an orally-active selective ghrelin receptor agonist which has shown anabolic and appetite-stimulating effects.
|
Placebo
n=2 Participants
Patients randomized to Placebo will take it daily for 24 weeks starting 3-5 days prior to chemotherapy.
|
|---|---|---|
|
Adverse Events
|
0 of events
|
0 of events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to week 25 (end of the study)Population: Data for this outcome was not collected for any patient; no patients were analyzed.
Number of unplanned visits for symptom management as defined by unscheduled clinic visits, emergency department visits, or hospitalizations
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: from baseline to week 13Population: Chemotherapy dose change data was not collected for any patient. This outcome measure was not analyzed.
Percent change in dose intensity of chemotherapy as defined by percent reduction in anticipated chemotherapy dose as determined by the treating physician.
Outcome measures
Outcome data not reported
Adverse Events
Anamorelin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Anamorelin
n=2 participants at risk
Patients randomized to anamorelin HCL will take it daily for 24 weeks starting 3-5 days prior to chemotherapy.
Anamorelin Hydrochloride: Anamorelin HCl is an orally-active selective ghrelin receptor agonist which has shown anabolic and appetite-stimulating effects.
|
Placebo
n=2 participants at risk
Patients randomized to placebo will take it daily for 24 weeks starting 3-5 days prior to chemotherapy.
|
|---|---|---|
|
General disorders
fatigue
|
0.00%
0/2 • AE data was to be collected from time of consent through the Week 25 visit. Patients on the anamorelin arm both withdrew, data was collected until withdraw of consent. One patient on the placebo arm ended the study prior to week 13 (data collected up until they ended) and another patients data was analyzed through week 25.
AE definitions do not differ.
|
50.0%
1/2 • Number of events 1 • AE data was to be collected from time of consent through the Week 25 visit. Patients on the anamorelin arm both withdrew, data was collected until withdraw of consent. One patient on the placebo arm ended the study prior to week 13 (data collected up until they ended) and another patients data was analyzed through week 25.
AE definitions do not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/2 • AE data was to be collected from time of consent through the Week 25 visit. Patients on the anamorelin arm both withdrew, data was collected until withdraw of consent. One patient on the placebo arm ended the study prior to week 13 (data collected up until they ended) and another patients data was analyzed through week 25.
AE definitions do not differ.
|
50.0%
1/2 • Number of events 1 • AE data was to be collected from time of consent through the Week 25 visit. Patients on the anamorelin arm both withdrew, data was collected until withdraw of consent. One patient on the placebo arm ended the study prior to week 13 (data collected up until they ended) and another patients data was analyzed through week 25.
AE definitions do not differ.
|
Other adverse events
| Measure |
Anamorelin
n=2 participants at risk
Patients randomized to anamorelin HCL will take it daily for 24 weeks starting 3-5 days prior to chemotherapy.
Anamorelin Hydrochloride: Anamorelin HCl is an orally-active selective ghrelin receptor agonist which has shown anabolic and appetite-stimulating effects.
|
Placebo
n=2 participants at risk
Patients randomized to placebo will take it daily for 24 weeks starting 3-5 days prior to chemotherapy.
|
|---|---|---|
|
Psychiatric disorders
confusion
|
0.00%
0/2 • AE data was to be collected from time of consent through the Week 25 visit. Patients on the anamorelin arm both withdrew, data was collected until withdraw of consent. One patient on the placebo arm ended the study prior to week 13 (data collected up until they ended) and another patients data was analyzed through week 25.
AE definitions do not differ.
|
50.0%
1/2 • Number of events 1 • AE data was to be collected from time of consent through the Week 25 visit. Patients on the anamorelin arm both withdrew, data was collected until withdraw of consent. One patient on the placebo arm ended the study prior to week 13 (data collected up until they ended) and another patients data was analyzed through week 25.
AE definitions do not differ.
|
|
Nervous system disorders
dizziness
|
0.00%
0/2 • AE data was to be collected from time of consent through the Week 25 visit. Patients on the anamorelin arm both withdrew, data was collected until withdraw of consent. One patient on the placebo arm ended the study prior to week 13 (data collected up until they ended) and another patients data was analyzed through week 25.
AE definitions do not differ.
|
50.0%
1/2 • Number of events 1 • AE data was to be collected from time of consent through the Week 25 visit. Patients on the anamorelin arm both withdrew, data was collected until withdraw of consent. One patient on the placebo arm ended the study prior to week 13 (data collected up until they ended) and another patients data was analyzed through week 25.
AE definitions do not differ.
|
|
Renal and urinary disorders
hematuria
|
0.00%
0/2 • AE data was to be collected from time of consent through the Week 25 visit. Patients on the anamorelin arm both withdrew, data was collected until withdraw of consent. One patient on the placebo arm ended the study prior to week 13 (data collected up until they ended) and another patients data was analyzed through week 25.
AE definitions do not differ.
|
50.0%
1/2 • Number of events 1 • AE data was to be collected from time of consent through the Week 25 visit. Patients on the anamorelin arm both withdrew, data was collected until withdraw of consent. One patient on the placebo arm ended the study prior to week 13 (data collected up until they ended) and another patients data was analyzed through week 25.
AE definitions do not differ.
|
|
Respiratory, thoracic and mediastinal disorders
productive cough
|
0.00%
0/2 • AE data was to be collected from time of consent through the Week 25 visit. Patients on the anamorelin arm both withdrew, data was collected until withdraw of consent. One patient on the placebo arm ended the study prior to week 13 (data collected up until they ended) and another patients data was analyzed through week 25.
AE definitions do not differ.
|
50.0%
1/2 • Number of events 1 • AE data was to be collected from time of consent through the Week 25 visit. Patients on the anamorelin arm both withdrew, data was collected until withdraw of consent. One patient on the placebo arm ended the study prior to week 13 (data collected up until they ended) and another patients data was analyzed through week 25.
AE definitions do not differ.
|
|
Gastrointestinal disorders
ascities
|
0.00%
0/2 • AE data was to be collected from time of consent through the Week 25 visit. Patients on the anamorelin arm both withdrew, data was collected until withdraw of consent. One patient on the placebo arm ended the study prior to week 13 (data collected up until they ended) and another patients data was analyzed through week 25.
AE definitions do not differ.
|
50.0%
1/2 • Number of events 1 • AE data was to be collected from time of consent through the Week 25 visit. Patients on the anamorelin arm both withdrew, data was collected until withdraw of consent. One patient on the placebo arm ended the study prior to week 13 (data collected up until they ended) and another patients data was analyzed through week 25.
AE definitions do not differ.
|
|
General disorders
fatigue
|
0.00%
0/2 • AE data was to be collected from time of consent through the Week 25 visit. Patients on the anamorelin arm both withdrew, data was collected until withdraw of consent. One patient on the placebo arm ended the study prior to week 13 (data collected up until they ended) and another patients data was analyzed through week 25.
AE definitions do not differ.
|
50.0%
1/2 • Number of events 1 • AE data was to be collected from time of consent through the Week 25 visit. Patients on the anamorelin arm both withdrew, data was collected until withdraw of consent. One patient on the placebo arm ended the study prior to week 13 (data collected up until they ended) and another patients data was analyzed through week 25.
AE definitions do not differ.
|
Additional Information
Julia Roache, Manger, Research Programs
Lahey Hospital & Medical Center
Phone: 7817443055
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place