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Growth Hormone Secretagogue Receptor Agonist
Anamorelin for Pancreatic Cancer
Phase 2
Recruiting
Research Sponsored by Lahey Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 25 weeks
Awards & highlights
Study Summary
This trial is testing a new drug to see if it's effective and safe for people with a certain type of cancer.
Who is the study for?
Adults over 18 with advanced pancreatic cancer and cachexia (weight loss and muscle wasting), who have not had major surgery recently, are not pregnant or breastfeeding, do not have other severe health issues like heart failure or uncontrolled diabetes, and can take pills. They must be willing to follow the study rules and use reliable contraception if necessary.Check my eligibility
What is being tested?
The trial is testing Anamorelin HCl against a placebo in people with advanced pancreatic cancer. Participants will randomly receive either the drug or a placebo once daily before their first meal for 25 weeks to see if it helps improve appetite and weight.See study design
What are the potential side effects?
Specific side effects of Anamorelin HCl aren't listed here, but common ones may include nausea, fatigue, increased blood sugar levels, and potential heart-related issues due to its intended effects on appetite and metabolism.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 25 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~25 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Weight change
Secondary outcome measures
AEs
Anorexia Questionnaire
Fatigue Questionnaire
+4 moreOther outcome measures
Chemotherapy Dose change
Unplanned visits
Side effects data
From 2023 Phase 1 trial • 32 Patients • NCT0402170612%
GI bloating
6%
hematuria
6%
high blood sugar
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anamorelin
Microcrystaline Cellulose
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AnamorelinExperimental Treatment1 Intervention
Patients randomized to anamorelin HCL will take it daily for 24 weeks starting 3-5 days prior to chemotherapy
Group II: PlaceboPlacebo Group1 Intervention
Patients randomized to placebo will take it daily for 24 weeks starting 3-5 days prior to chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anamorelin Hydrochloride
2019
Completed Phase 3
~350
Find a Location
Who is running the clinical trial?
Lahey ClinicLead Sponsor
72 Previous Clinical Trials
245,145 Total Patients Enrolled
Helsinn Healthcare SAIndustry Sponsor
41 Previous Clinical Trials
9,359 Total Patients Enrolled
Quartesian LLCUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My BMI is under 20 and I've lost weight without trying.I am eligible for my first round of chemotherapy to ease symptoms.I am taking medication to help with appetite or prevent weight loss.My diagnosis is advanced pancreatic cancer that cannot be surgically removed.I have eating problems due to my cancer, confirmed by specific appetite tests.I have recently used medications that affect liver enzyme CYP3A4.I cannot swallow pills.I am currently using medication that can affect my heart's electrical activity.I have started pancreatic enzyme replacement therapy.My pancreatic cancer is not the common type, like a neuroendocrine tumor.I am not pregnant or breastfeeding.I have not had major surgery in the last 4 weeks and do not plan to during the study.I have severe weight loss not caused by my current cancer.I have had weight loss surgery or have a condition that affects how my body absorbs food.I am currently receiving nutrition through a tube or IV.I don't have severe eating problems due to conditions like severe mouth sores or blockages.Criterion: You have uncontrolled or significant heart problems, such as recent heart attack, unstable angina, severe heart failure, or certain abnormal heart rhythms. You also have uncontrolled high blood pressure, very slow heart rate with symptoms, uncontrolled diabetes, uncontrolled pain, or other conditions that could make it unsafe for you to take part in the study.I am 18 years old or older.I am either not able to have children or I am using birth control and have a recent negative pregnancy test.I am fully active or restricted in physically strenuous activity but can do light work.I have fluid buildup needing drainage in my chest, heart area, or abdomen.My liver functions are within the required range.
Research Study Groups:
This trial has the following groups:- Group 1: Anamorelin
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many research subjects are being enrolled in this trial?
"That is correct. The clinical trial in question, which was originally posted on 9/30/2022, has an active listing on clinicaltrials.gov and is currently recruiting 100 participants from 1 location."
Answered by AI
Are there any know risks associated with Anamorelin Hydrochloride?
"There is some clinical data suggesting Anamorelin Hydrochloride is safe, but not yet any evidence that it is effective. Therefore, it received a score of 2."
Answered by AI
Are patients currently being accepted for this clinical trial?
"This clinical trial, as indicated on clinicaltrials.gov, is currently looking for eligible candidates. The study was first posted on 9/30/2022 and was last updated on 2/1/2022."
Answered by AI
Are there any other studies that have used Anamorelin Hydrochloride?
"There are currently 6 active clinical trials studying the effects of Anamorelin Hydrochloride. This medication is being trialed in 153 locations, with 3 of those studies in Phase 3."
Answered by AI
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