TERMINATED

Anamorelin Study for Advanced Pancreatic Cancer

Conditions

Metastatic Pancreatic Cancer Phase II Randomized double-blind placebo-controlled Anamorelin HCI Cachexia Anorexia Weight loss FAACT A/CS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 day

Official Title

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

Quick Facts

Study Start:2023-04-01

Study Completion:2023-11-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT04844970

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	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.

Inclusion Criteria

Exclusion 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).

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.

Contacts and Locations

Principal Investigator

Keith Stuart

PRINCIPAL_INVESTIGATOR

Lahey Hospital & Medical Center

Study Locations (Sites)

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805

United States

Collaborators and Investigators

Sponsor: Lahey Clinic

Keith Stuart, PRINCIPAL_INVESTIGATOR, Lahey Hospital & Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-01

Study Completion Date2023-11-07

Study Record Updates

Study Start Date2023-04-01

Study Completion Date2023-11-07

Terms related to this study

Keywords Provided by Researchers

Phase II
Randomized
double-blind
placebo-controlled
Anamorelin HCI
Cachexia
Anorexia
Weight loss
FAACT A/CS

Additional Relevant MeSH Terms

Metastatic Pancreatic Cancer