Metastatic Pancreatic CancerPhase 2NCT04844970
Anamorelin Study for Advanced Pancreatic Cancer
A Phase 2 study testing Anamorelin Hydrochloride in people with Metastatic Pancreatic Cancer, run by Lahey Clinic at 1 site in United States.
Trial summary
Multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of anamorelin HCl. Approximately 100 subjects with advanced PDAC and cachexia will be randomized 1:1 to anamorelin HCl 100 mg or placebo, taken orally once daily (QD) for a total of 25 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- Anamorelin Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 7 Nov 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Female or male ≥18 years of age
- Documented histologic or cytologic diagnosis of American Joint Committee on Cancer (AJCC) unresectable or metastatic pancreatic adenocarcinoma
- Body mass index < 20 kg/m2 with involuntary weight loss or >5% within 6 months prior to screening
- Ongoing problems with appetite/eating associated with the underlying cancer, as determined by having score of ≤ 17 points on the 5-item Anorexia Symptom Scale and ≤ 37 points on the 12-item FAACT A/CS
- Subjects eligible to receive first line palliative chemotherapy
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- ECOG performance status 0 or 1 at screening
- Acceptable hepatic function as defined by total bilirubin < 1.6 mg/dl unless associated with Gilbert syndrome, then total bilirubin < 2 x ULN. AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN or if hepatic metastases are present ≤ 5 x ULN
- Appropriate treatment with pancreatic enzyme replacement prior to trial initiation
- Female subjects shall be:
- of non-childbearing potential or
- of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test within 24 hours prior to first dose of investigational product.
- The patient must be willing and able to comply with the protocol tests and procedures All inclusion criteria will be checked at screening visit (Visit 1).
Who cannot join
- Patient with other forms of pancreatic cancer (e.g. neuroendocrine tumors)
- Patient undergoing major surgery within 4 weeks of randomization or plans to undergo major surgery during study period.
- Women who are pregnant or breastfeeding
- Patient with alternative cause of cachexia as determined by the investigator including: a) severe COPD requiring O2, b) severe heart failure (NYHA Class III- IV), c) second malignancy
- Reversible causes of reduced food intake as determined by the investigator including but not limited to: severe mucositis (>=NCI CTCAE grade 3), mechanical obstruction, severe nausea, vomiting, or diarrhea (>=NCI CTCAE grade 3)
- Patient unable to swallow pills
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- Patient with history of bariatric surgery, gastrectomy, or malabsorption disorder (gastritis, esophagitis)
- Patient with recent use of CYP3A4 inhibitors
- Patient with current daily use of therapies that may increase the QRS interval durations
- Patient currently taking medications/compounds intended to increase appetite or decrease weight loss (e.g. testosterone, megestrol acetate, cannabis products, methylphenidate, corticosteroids, olanzapine, mirtazapine (allowed if >4 weeks of use as therapy for depression)
- Patient with current use of tube feeding or parenteral feeding
- Patient with pleural effusion requiring thoracentesis, pericardial effusion requiring drainage, edema or evidence of ascites
- Patient with uncontrolled or significant cardiovascular disease, including:
- History of myocardial infarction within the past 3 months
- A-V block of second or third degree (may be eligible if currently have a pacemaker)
- Unstable angina
- Congestive heart failure within the past 3 months, if defined as NYHA class III-IV
- Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW) syndrome, or torsade de pointes)
- Uncontrolled hypertension (blood pressure >150 mm Hg systolic and >95 mm Hg diastolic)
- Heart rate < 50 beats per minute on pre-entry electrocardiogram and patient is symptomatic
- Patient with uncontrolled diabetes mellitus or unmonitored diabetes mellitus
- Patient with uncontrolled pain.
- Any condition, including the presence of laboratory abnormalities, which in the Investigator's opinion, places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Enrollment in a previous study with anamorelin HCl
- Enrollment in another clinical trial during the time of this trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
About this study
Official title: A Randomized, Double-blind, and Placebo Controlled Multicenter Phase II Trial Evaluating Anamorelin in the Prevention of Cancer Induced-Weight Loss and Anorexia in Patients Receiving First-line Treatment of Advanced Pancreatic Cancer
Multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of anamorelin HCl. Approximately 100 subjects with advanced PDAC and cachexia will be randomized 1:1 to anamorelin HCl 100 mg or placebo, taken orally once daily (QD) for a total of 25 weeks. Subjects will be instructed to take the study drug at least 1 hour before their first meal of the day
Read the detailed description
Anorexia and cachexia are common clinical sequelae of uncontrolled, metastatic cancer. These effects can impair physical function, reduce quality of life, impair tolerability of anticancer therapy, and reduce survival. Anorexia and cachexia are especially challenging problems in patients diagnosed with metastatic pancreatic cancer. With an annual incidence approaching 50,000 patients in the U.S. alone, pancreatic cancer has an annual mortality of approximately 40,000 patients with most individuals succumbing to their disease within two years. Between 70-80% of patients with metastatic pancreatic cancer experience cancer cachexia, which has been associated with reduced survival, increased risk of disease progression, and impaired chemotherapy tolerance.
Anamorelin HCl is an orally-active selective ghrelin receptor agonist which has shown anabolic and appetite-stimulating effects. Several randomized, double-blind, clinical trials in cancer patients have shown that anamorelin HCL is safe, efficacious and increases lean body mass, bodyweight, and appetite. Investigators propose to test anamorelin HCL administered with chemotherapy in the first-line treatment of locally advanced unresectable and metastatic pancreatic cancer.
The study is a randomized, placebo controlled multicenter, Phase II trial to evaluate the efficacy and safety of anamorelin HCl. Approximately 100 patients with be enrolled in a 1:1 randomization to anamorelin HCL 100mg per day given concurrently with first-line chemotherapy compared to chemotherapy alone. Patients randomized to anamorelin HCL will take it daily for 24 weeks starting one day prior to chemotherapy. All patients will undergo an assessment by a certified nutritionist at or prior to their first cycle of chemotherapy. Both body weight and appetite will be measured at enrollment as well as at the initiation of chemotherapy. Patients will be stratified by degree of weight loss in the six months prior to enrollment, choice of first-line chemotherapy, and by baseline score of 5-item Anorexia Symptom Scale.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- Anamorelin Hydrochloride, Placebo
- Keywords
- Phase II, Randomized, double-blind, placebo-controlled, Anamorelin HCI, Cachexia, Anorexia, Weight loss, FAACT A/CS
- Medical subject headings
- Pancreatic Neoplasms, Cachexia, Anorexia, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anamorelin HydrochlorideDrug
Anamorelin HCl is an orally-active selective ghrelin receptor agonist which has shown anabolic and appetite-stimulating effects.
PlaceboDrug
Anamorelin placebo
| Study group | Role | What they receive |
|---|---|---|
| Anamorelin | Experimental | Patients randomized to anamorelin HCL will take it daily for 24 weeks starting 3-5 days prior to chemotherapy Receives: Drug: Anamorelin Hydrochloride |
| Placebo | Placebo comparator | Patients randomized to placebo will take it daily for 24 weeks starting 3-5 days prior to chemotherapy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Weight Change From Baseline to Week 25
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.
Measured: 25 weeks from baseline
Secondary outcomes (7)
Anorexia Questionnaire
Absolute change in the Functional Assessment of Anorexia/Cachexia Treatment (FAACT 5) item Anorexia Symptom Score from baseline at week 13
Measured: from baseline to week 13
Survival
Overall Survival
Measured: 25 weeks
Radiologic Response to Chemotherapy
Chemotherapy response will be evaluated by RECIST criteria
Measured: from baseline to week 13
Weight Gain
Measured: from baseline to week 25 (end of the study)
Fatigue Questionnaire
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire, fatigue subscale
Measured: from baseline to week 13
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
expected toxicities for Chemotherapies (FOLFIRINOX and Gemcitabine/Nab-Paclitaxel) will be assessed by CTCAE v5.0
Measured: from baseline to week 25 (end of study)
Adverse Events
Number of AEs that are definitely related to Anamorelin or Placebo.
Measured: from baseline to week 25 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start1 Apr 2023
- Primary completion7 Nov 2023
- Study completion7 Nov 2023
Why it stopped: The study closure was initiated by the financial sponsor and agreed upon by the site PI. The study is closing because of low enrollment and insufficient funds.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group receives Anamorelin, and the other group receives placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinn Healthcare SA, Quartesian LLC
- Responsible party
- Sponsor
- Investigators
- Keith Stuart, Principal investigator, Lahey Hospital & Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844970
- Sponsor's protocol ID
- LHMC 20193054
- Status last verified
- Nov 2025
- First submitted
- 9 Mar 2021
- Last updated
- 17 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, and Placebo Controlled Multicenter Phase II Trial Evaluating Anamorelin in the Prevention of Cancer Induced-Weight Loss and Anorexia in Patients Receiving First-line Treatment of Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04844970
- Acronym / sponsor ID
- LHMC 20193054
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- Phase II, Randomized, double-blind, placebo-controlled, Anamorelin HCI, Cachexia, Anorexia, Weight loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study closure was initiated by the financial sponsor and agreed upon by the site PI. The study is closing because of low enrollment and insufficient funds.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Collaborators
- Helsinn Healthcare SA, Quartesian LLC
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 14 Apr 2021 (actual)
- Results
- Posted 17 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of anamorelin HCl. Approximately 100 subjects with advanced PDAC and cachexia will be randomized 1:1 to anamorelin HCl 100 mg or placebo, taken orally once daily (QD) for a total of 25 weeks. Subjects will be instructed to take the study drug at least 1 hour before their first meal of the day
Detailed description
Anorexia and cachexia are common clinical sequelae of uncontrolled, metastatic cancer. These effects can impair physical function, reduce quality of life, impair tolerability of anticancer therapy, and reduce survival. Anorexia and cachexia are especially challenging problems in patients diagnosed with metastatic pancreatic cancer. With an annual incidence approaching 50,000 patients in the U.S. alone, pancreatic cancer has an annual mortality of approximately 40,000 patients with most individuals succumbing to their disease within two years. Between 70-80% of patients with metastatic pancreatic cancer experience cancer cachexia, which has been associated with reduced survival, increased risk of disease progression, and impaired chemotherapy tolerance.
Anamorelin HCl is an orally-active selective ghrelin receptor agonist which has shown anabolic and appetite-stimulating effects. Several randomized, double-blind, clinical trials in cancer patients have shown that anamorelin HCL is safe, efficacious and increases lean body mass, bodyweight, and appetite. Investigators propose to test anamorelin HCL administered with chemotherapy in the first-line treatment of locally advanced unresectable and metastatic pancreatic cancer.
The study is a randomized, placebo controlled multicenter, Phase II trial to evaluate the efficacy and safety of anamorelin HCl. Approximately 100 patients with be enrolled in a 1:1 randomization to anamorelin HCL 100mg per day given concurrently with first-line chemotherapy compared to chemotherapy alone. Patients randomized to anamorelin HCL will take it daily for 24 weeks starting one day prior to chemotherapy. All patients will undergo an assessment by a certified nutritionist at or prior to their first cycle of chemotherapy. Both body weight and appetite will be measured at enrollment as well as at the initiation of chemotherapy. Patients will be stratified by degree of weight loss in the six months prior to enrollment, choice of first-line chemotherapy, and by baseline score of 5-item Anorexia Symptom Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- One group receives Anamorelin, and the other group receives placebo.
| Arm | Type | Receives |
|---|---|---|
| Anamorelin | Experimental | Drug: Anamorelin HydrochloridePatients randomized to anamorelin HCL will take it daily for 24 weeks starting 3-5 days prior to chemotherapy |
| Placebo | Placebo comparator | Drug: PlaceboPatients randomized to placebo will take it daily for 24 weeks starting 3-5 days prior to chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed written informed consent
- Female or male ≥18 years of age
- Documented histologic or cytologic diagnosis of American Joint Committee on Cancer (AJCC) unresectable or metastatic pancreatic adenocarcinoma
- Body mass index < 20 kg/m2 with involuntary weight loss or >5% within 6 months prior to screening
- Ongoing problems with appetite/eating associated with the underlying cancer, as determined by having score of ≤ 17 points on the 5-item Anorexia Symptom Scale and ≤ 37 points on the 12-item FAACT A/CS
Key exclusion criteria (25 listed)
- Patient with other forms of pancreatic cancer (e.g. neuroendocrine tumors)
- Patient undergoing major surgery within 4 weeks of randomization or plans to undergo major surgery during study period.
- Women who are pregnant or breastfeeding
- Patient with alternative cause of cachexia as determined by the investigator including: a) severe COPD requiring O2, b) severe heart failure (NYHA Class III- IV), c) second malignancy
- Reversible causes of reduced food intake as determined by the investigator including but not limited to: severe mucositis (>=NCI CTCAE grade 3), mechanical obstruction, severe nausea, vomiting, or diarrhea (>=NCI CTCAE grade 3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anamorelin HydrochlorideAnamorelin HCl is an orally-active selective ghrelin receptor agonist which has shown anabolic and appetite-stimulating effects. | Drug | Anamorelin |
| PlaceboAnamorelin placebo | Drug | Placebo |
Primary outcome
Percent Weight Change From Baseline to Week 25
Time frame: 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.
7 secondary outcomes
Anorexia Questionnaire
Time frame: from baseline to week 13
Survival
Time frame: 25 weeks
Radiologic Response to Chemotherapy
Time frame: from baseline to week 13
Weight Gain
Time frame: from baseline to week 25 (end of the study)
Fatigue Questionnaire
Time frame: from baseline to week 13
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
Time frame: from baseline to week 25 (end of study)
Adverse Events
Time frame: from baseline to week 25 (end of study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Stuart principal investigator
Lahey Hospital & Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anamorelin Hydrochloride in people with Metastatic Pancreatic Cancer, run by Lahey Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Weight Change From Baseline to Week 25 (time frame: 25 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.