Anamorelin Study for Advanced Pancreatic Cancer

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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. Subjects will be instructed to take the study drug at least 1 hour before their first meal of the day

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lahey Clinic
• Collaborators: Helsinn Healthcare SA; Quartesian LLC

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.