← Back to Search

Growth Hormone Secretagogue Receptor Agonist

Anamorelin Hydrochloride for Non-Small Cell Lung Cancer

Phase 2 & 3
Waitlist Available
Led By Sriram Yennu
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a history of either: >= 5% of weight loss for body mass index (BMI) >= 20 kg/m^2 or >= 2% of weight loss for BMI < 20 kg/m^2, over a period of 1 year
Patients must be willing to keep a daily medication diary and engage in telephone follow up with research staff
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to day 64
Awards & highlights

Study Summary

This trial studies how well anamorelin hydrochloride works in reducing anorexia in patients with non-small cell lung cancer.

Who is the study for?
This trial is for adults with advanced non-small cell lung cancer who are experiencing anorexia (loss of appetite) and weight loss. They must have a life expectancy of at least 6 months, be able to use the phone for follow-ups, and keep a medication diary. Pregnant women or those not using contraception are excluded, as well as patients on certain medications or with uncontrolled diabetes.Check my eligibility
What is being tested?
The trial is testing Anamorelin Hydrochloride's effectiveness in improving appetite and preventing weight loss in patients with advanced non-small cell lung cancer. Participants will either receive this drug or a placebo while their condition is monitored through questionnaires.See study design
What are the potential side effects?
While specific side effects aren't listed here, Anamorelin Hydrochloride may cause reactions similar to other appetite stimulants such as gastrointestinal discomfort, changes in blood sugar levels, fatigue, and potential hormonal imbalances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have lost more than 5% of my weight in a year and my BMI is 20 or higher, or I have lost more than 2% of my weight in a year and my BMI is less than 20.
Select...
I am willing to keep a daily medication diary and talk on the phone with research staff.
Select...
I have a phone for research staff to contact me.
Select...
My liver tests, AST and ALT, are within normal limits.
Select...
I have been diagnosed with advanced non-small cell lung cancer.
Select...
I am experiencing significant loss of appetite.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to day 64
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to day 64 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To reach thematic saturation by qualitatively examining experiences related to anorexia at the baseline in advanced lung cancer patients with anorexia/cachexia receiving either oral Anamorelin 100 mg or placebo.
Secondary outcome measures
Explore any associations between changes in anorexia assessed by Patient Global Impression of Change (PGIC)
Explore any associations between changes in anorexia assessed by Patient Global Impression of Severity (PGIS) Scale
Explore any associations between changes in anorexia with food intake after 9 weeks of oral Anamorelin 100 mg or placebo treatment
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (anamorelin hydrochloride)Experimental Treatment2 Interventions
Patients receive anamorelin hydrochloride PO daily for 9 weeks in the absence of disease progression or unaccepted toxicity.
Group II: Arm II (placebo)Placebo Group2 Interventions
Patients receive placebo PO daily for 9 weeks in the absence of disease progression or unaccepted toxicity.
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?

M.D. Anderson Cancer CenterLead Sponsor
2,959 Previous Clinical Trials
1,798,465 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,615 Previous Clinical Trials
40,918,595 Total Patients Enrolled
Sriram YennuPrincipal InvestigatorM.D. Anderson Cancer Center
12 Previous Clinical Trials
1,532 Total Patients Enrolled

Media Library

Anamorelin Hydrochloride (Growth Hormone Secretagogue Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03637816 — Phase 2 & 3
Lung Cancer Research Study Groups: Arm I (anamorelin hydrochloride), Arm II (placebo)
Lung Cancer Clinical Trial 2023: Anamorelin Hydrochloride Highlights & Side Effects. Trial Name: NCT03637816 — Phase 2 & 3
Anamorelin Hydrochloride (Growth Hormone Secretagogue Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03637816 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does the research say about Anamorelin Hydrochloride's effectiveness?

"There are currently 6 clinical trials underway for Anamorelin Hydrochloride, 3 of which are in Phase 3. Deszk, Bihor is the primary location for these trials, but Anamorelin Hydrochloride is being tested in 153 different centres."

Answered by AI
~3 spots leftby Dec 2024