Anamorelin Study for Advanced Pancreatic Cancer

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 priorto screening
5. Ongoing problems with appetite/eating associated with the underlying cancer, asdetermined 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 unlessassociated 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:
11. of non-childbearing potential or
12. of childbearing potential using reliable contraceptive measures and having anegative urine pregnancy test within 24 hours prior to first dose ofinvestigational product.
13. The patient must be willing and able to comply with the protocol tests and proceduresAll 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 undergomajor surgery during study period.
3. Women who are pregnant or breastfeeding
4. Patient with alternative cause of cachexia as determined by the investigatorincluding: 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 includingbut 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 intervaldurations
10. Patient currently taking medications/compounds intended to increase appetite ordecrease weight loss (e.g. testosterone, megestrol acetate, cannabis products,methylphenidate, corticosteroids, olanzapine, mirtazapine (allowed if >4 weeks of useas therapy for depression)
11. Patient with current use of tube feeding or parenteral feeding
12. Patient with pleural effusion requiring thoracentesis, pericardial effusion requiringdrainage, edema or evidence of ascites
13. Patient with uncontrolled or significant cardiovascular disease, including:
14. History of myocardial infarction within the past 3 months
15. A-V block of second or third degree (may be eligible if currently have apacemaker)
16. Unstable angina
17. Congestive heart failure within the past 3 months, if defined as NYHA classIII-IV
18. Any history of clinically significant ventricular arrhythmias (such asventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW)syndrome, or torsade de pointes)
19. Uncontrolled hypertension (blood pressure >150 mm Hg systolic and >95 mm Hgdiastolic)
20. Heart rate < 50 beats per minute on pre-entry electrocardiogram and patient issymptomatic
21. Patient with uncontrolled diabetes mellitus or unmonitored diabetes mellitus
22. Patient with uncontrolled pain.
23. Any condition, including the presence of laboratory abnormalities, which in theInvestigator's opinion, places the subject at unacceptable risk if he/she were toparticipate in the study or confounds the ability to interpret data from the study
24. Enrollment in a previous study with anamorelin HCl
25. Enrollment in another clinical trial during the time of this trial.