Trial · NCT04844970

Anamorelin Study for Advanced Pancreatic Cancer

NCT04844970, Phase 2, Terminated, Lahey Clinic; results first posted 2025-11-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Anamorelin Study for Advanced Pancreatic Cancer. Trials, record NCT04844970. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04844970

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Anamorelin Study for Advanced Pancreatic Cancer
NCT number: NCT04844970
Status: Terminated
Phases: Phase 2
Enrollment: 4 participants, actual
Lead sponsor: Lahey Clinic
Conditions: Metastatic Pancreatic Cancer
Interventions: Anamorelin Hydrochloride, Placebo
First posted: 2021-04-14
Last updated: 2025-11-17
Results first posted: 2025-11-17
Limitations and caveats: This study closed to accrual early, with the limited number of participants, we were unable to analyze the data.

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Weight Change From Baseline to Week 25	25 weeks from baseline	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.
Secondary	Anorexia Questionnaire	from baseline to week 13	Absolute change in the Functional Assessment of Anorexia/Cachexia Treatment (FAACT 5) item Anorexia Symptom Score from baseline at week 13
Secondary	Survival	25 weeks	Overall Survival
Secondary	Radiologic Response to Chemotherapy	from baseline to week 13	Chemotherapy response will be evaluated by RECIST criteria
Secondary	Weight Gain	from baseline to week 25 (end of the study)
Secondary	Fatigue Questionnaire	from baseline to week 13	Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire, fatigue subscale
Secondary	Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0	from baseline to week 25 (end of study)	expected toxicities for Chemotherapies (FOLFIRINOX and Gemcitabine/Nab-Paclitaxel) will be assessed by CTCAE v5.0
Secondary	Adverse Events	from baseline to week 25 (end of study)	Number of AEs that are definitely related to Anamorelin or Placebo.
Other	Unplanned Visits	From baseline to week 25 (end of the study)	Number of unplanned visits for symptom management as defined by unscheduled clinic visits, emergency department visits, or hospitalizations
Other	Chemotherapy Dose Change	from baseline to week 13	Percent change in dose intensity of chemotherapy as defined by percent reduction in anticipated chemotherapy dose as determined by the treating physician.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Weight Change From Baseline to Week 25	25 weeks from baseline	No patients were analyzed for this outcome measure because no weight was collected at the 25-week time point.
SECONDARY	Anorexia Questionnaire	from baseline to week 13	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.
SECONDARY	Survival	25 weeks	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Radiologic Response to Chemotherapy	from baseline to week 13	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.
SECONDARY	Weight Gain	from baseline to week 25 (end of the study)	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.
SECONDARY	Fatigue Questionnaire	from baseline to week 13	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.
SECONDARY	Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0	from baseline to week 25 (end of study)	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Adverse Events	from baseline to week 25 (end of study)	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.	of events	NUMBER
OTHER_PRE_SPECIFIED	Unplanned Visits	From baseline to week 25 (end of the study)	Data for this outcome was not collected for any patient; no patients were analyzed.
OTHER_PRE_SPECIFIED	Chemotherapy Dose Change	from baseline to week 13	Chemotherapy dose change data was not collected for any patient. This outcome measure was not analyzed.

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Survival	Placebo	1	Participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0	Anamorelin	0	Participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0	Placebo	1	Participants
Adverse Events	Anamorelin	0	of events
Adverse Events	Placebo	0	of events

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Anamorelin	2
Overall Study	STARTED	Placebo	2
Overall Study	COMPLETED	Anamorelin	0
Overall Study	COMPLETED	Placebo	1
Overall Study	NOT COMPLETED	Anamorelin	2
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	confusion	Psychiatric disorders	Anamorelin	0	2	0
other	confusion	Psychiatric disorders	Placebo	1	2	1
other	dizziness	Nervous system disorders	Anamorelin	0	2	0
other	dizziness	Nervous system disorders	Placebo	1	2	1
other	hematuria	Renal and urinary disorders	Anamorelin	0	2	0
other	hematuria	Renal and urinary disorders	Placebo	1	2	1
other	productive cough	Respiratory, thoracic and mediastinal disorders	Anamorelin	0	2	0
other	productive cough	Respiratory, thoracic and mediastinal disorders	Placebo	1	2	1
other	ascities	Gastrointestinal disorders	Anamorelin	0	2	0
other	ascities	Gastrointestinal disorders	Placebo	1	2	1

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Anamorelin	0	2
Total, all-cause mortality	Placebo	1	2
Total, other adverse events	Anamorelin	0	2
Total, other adverse events	Placebo	1	2
Total, serious adverse events	Anamorelin	0	2
Total, serious adverse events	Placebo	1	2

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Anamorelin vs Placebo: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0	Trial comparisons
Anamorelin vs Placebo: deaths from any cause	Trial comparisons
Anamorelin vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04844970

GET https://conductscience.org/api/trials/v1/NCT04844970/registered

API reference For AI assistants