Anamorelin Study for Advanced Pancreatic Cancer

Trial details

Who runs it

Lahey Clinic

Trial code

NCT04844970

Record updated

2025. november 17.

Original description

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 dayRead full original descriptionShow less

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

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

Inclusion: 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: Patient undergoing major surgery within 4 weeks of randomization or plans to undergo major surgery during study period; 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); Enrollment in a previous study with anamorelin HCl; Patient with other forms of pancreatic cancer (e.g. neuroendocrine tumors); 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; Patient with history of bariatric surgery, gastrectomy, or malabsorption disorder (gastritis, esophagitis); 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; 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; Women who are pregnant or breastfeeding; 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 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 pain; Enrollment in another clinical trial during the time of this trial.

ClinicalTrials.gov NCT04844970