Anamorelin Study for Advanced Pancreatic Cancer

Inclusion Criteria

• 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
• 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).

Exclusion Criteria

• 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
• 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.