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

Trial ID: NCT04844970

Interventional - Phase 2 - Terminated

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

Conditions

• Metastatic Pancreatic Cancer

Interventions

• Anamorelin Hydrochloride
• Placebo

Eligibility

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.

Sponsor

Lahey Clinic, Helsinn Healthcare SA, Quartesian LLC

Source: ClinicalTrials.gov

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