Evaluating Anamorelin for Patients with Advanced Pancreatic Cancer

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

This study is testing if a new medication called anamorelin can help people with advanced pancreatic cancer who are struggling with appetite loss and weight loss feel better and improve their quality of life.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Lahey Clinic (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Burlington, Massachusetts)
• Trial ID: NCT04844970 on ClinicalTrials.gov

What this trial studies

This multicenter, double-blind, randomized, placebo-controlled trial aims to assess the efficacy and safety of anamorelin HCl in approximately 100 patients with advanced pancreatic cancer and cachexia. Participants will be randomly assigned to receive either anamorelin HCl or a placebo daily for 25 weeks, taken before meals. The study focuses on addressing the challenges of anorexia and cachexia, which significantly impact the quality of life and survival of patients with metastatic pancreatic cancer. Anamorelin is a selective ghrelin receptor agonist that has shown promise in increasing appetite and lean body mass in previous studies.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with unresectable or metastatic pancreatic adenocarcinoma and significant weight loss or appetite issues.

Not a fit: Patients who do not experience cachexia or significant appetite loss may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve appetite, body weight, and overall quality of life for patients suffering from advanced pancreatic cancer.

How similar studies have performed: Previous studies have shown that anamorelin HCl is safe and effective in increasing appetite and lean body mass in cancer patients, indicating a promising approach.

Eligibility criteria

Inclusion Criteria:

1. Signed written informed consent
2. Female or male ≥18 years of age
3. Documented histologic or cytologic diagnosis of American Joint Committee on Cancer (AJCC) unresectable or metastatic pancreatic adenocarcinoma
4. Body mass index \< 20 kg/m2 with involuntary weight loss or \>5% within 6 months prior to screening
5. 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
6. Subjects eligible to receive first line palliative chemotherapy
7. ECOG performance status 0 or 1 at screening
8. 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
9. Appropriate treatment with pancreatic enzyme replacement prior to trial initiation
10. Female subjects shall be:

    1. of non-childbearing potential or
    2. of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test within 24 hours prior to first dose of investigational product.
11. 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).

Exclusion Criteria:

1. Patient with other forms of pancreatic cancer (e.g. neuroendocrine tumors)
2. Patient undergoing major surgery within 4 weeks of randomization or plans to undergo major surgery during study period.
3. Women who are pregnant or breastfeeding
4. 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
5. 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)
6. Patient unable to swallow pills
7. Patient with history of bariatric surgery, gastrectomy, or malabsorption disorder (gastritis, esophagitis)
8. Patient with recent use of CYP3A4 inhibitors
9. Patient with current daily use of therapies that may increase the QRS interval durations
10. 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)
11. Patient with current use of tube feeding or parenteral feeding
12. Patient with pleural effusion requiring thoracentesis, pericardial effusion requiring drainage, edema or evidence of ascites
13. Patient with uncontrolled or significant cardiovascular disease, including:

    1. History of myocardial infarction within the past 3 months
    2. A-V block of second or third degree (may be eligible if currently have a pacemaker)
    3. Unstable angina
    4. Congestive heart failure within the past 3 months, if defined as NYHA class III-IV
    5. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW) syndrome, or torsade de pointes)
    6. Uncontrolled hypertension (blood pressure \>150 mm Hg systolic and \>95 mm Hg diastolic)
    7. Heart rate \< 50 beats per minute on pre-entry electrocardiogram and patient is symptomatic
14. Patient with uncontrolled diabetes mellitus or unmonitored diabetes mellitus
15. Patient with uncontrolled pain.
16. 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
17. Enrollment in a previous study with anamorelin HCl
18. Enrollment in another clinical trial during the time of this trial.

Where this trial is running

Burlington, Massachusetts

• Lahey Hospital & Medical Center — Burlington, Massachusetts, United States (RECRUITING)

Study contacts

• Study coordinator: Essence D Maston, PhD

Conditions: Metastatic Pancreatic Cancer, Phase II, Randomized, double-blind, placebo-controlled, Anamorelin HCI, Cachexia, Anorexia