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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
Adequate hepatic function, defined as aspartate transaminase (AST) and alanine transaminase (ALT) levels =< 5 x upper limit of normal (ULN)
Must not have
Uncontrolled diabetes mellitus (fasting blood sugar > 200 mg/dl) at screening
Patients on drugs that may prolong the PR or QRS interval durations, such as any of the class I/sodium (Na+) channel blocking antiarrhythmic medications should be avoided (e.g. flecainide, procainamide, propafenone, quinidine)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to day 64
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.
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.
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 belowSelect...
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...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My fasting blood sugar is not above 200 mg/dl.
Select...
I am not taking medications that affect heart rhythm, like flecainide or quinidine.
Select...
I haven't taken strong CYP3A4 inhibitors like ketoconazole in the last two weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to day 64
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to day 64
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreSide effects data
From 2023 Phase 3 trial • 318 Patients • NCT037430519%
Non-small cell lung cancer
9%
Anaemia
6%
Nausea
5%
Asthenia
4%
Hyperkalaemia
4%
Fatigue
4%
Dyspnoea
4%
Oedema Peripheral
3%
Decreased Appetite
3%
Platelet Count Decreased
3%
Hypocalcaemia
3%
Leukopenia
3%
Headache
3%
Diarrhoea
2%
Vomiting
2%
Metastases to central nervous system
1%
Osteonecrosis of jaw
1%
Back pain
1%
Depressed level of consciousness
1%
Chemical peritonitis
1%
Pain
1%
Sepsis
1%
Intracranial pressure increased
1%
Arthralgia
1%
Intestinal obstruction
1%
Oesophageal stenosis
1%
Autoimmune colitis
1%
Urinary bladder haemorrhage
1%
Viral infection
1%
Atrial flutter
1%
Acute respiratory failure
1%
Pulmonary embolism
1%
Respiratory failure
1%
Bronchitis
1%
Peritonitis
1%
Pneumonia
1%
Pericardial effusion
1%
Acute myocardial effusion
1%
Cardiac arrest
1%
Cardiac failure
1%
Myocardial infarction
1%
Gastric haemorrhage
1%
Ileus
1%
Small intestinal ulcer perforation
1%
Chronic obstructive pulmonary disease
1%
Hypoxia
1%
Cerebrovascular accident
1%
Haematuria
1%
Hydronephrosis
1%
Pancytopenia
1%
Pyrexia
1%
Thrombocytopenia
1%
Chest Pain
1%
Neutropenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
100 mg Anamorelin HCl
Placebo
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
3,074 Previous Clinical Trials
1,803,520 Total Patients Enrolled
2 Trials studying Anorexia
104 Patients Enrolled for Anorexia
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,555 Total Patients Enrolled
10 Trials studying Anorexia
1,209 Patients Enrolled for Anorexia
Sriram YennuPrincipal InvestigatorM.D. Anderson Cancer Center
12 Previous Clinical Trials
1,532 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have any condition that would make it hard for you to take part in one-on-one interviews in person or over the phone.You have a major reason why you cannot take anamorelin, such as being very sensitive or allergic to it.Your body mass index (BMI) is 28 or higher.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.I am willing to keep a daily medication diary and talk on the phone with research staff.I have a phone for research staff to contact me.I am not pregnant or breastfeeding, using birth control, and have a negative pregnancy test.My fasting blood sugar is not above 200 mg/dl.I am currently using medications or substances to increase my appetite or address weight loss.I have been diagnosed with advanced non-small cell lung cancer.My liver tests, AST and ALT, are within normal limits.You are expected to live for at least 6 more months.I am not taking medications that affect heart rhythm, like flecainide or quinidine.I am experiencing significant loss of appetite.I haven't taken strong CYP3A4 inhibitors like ketoconazole in the last two weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (anamorelin hydrochloride)
- Group 2: Arm II (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.