CLINICAL TRIALS PROFILE FOR ANAMORELIN

Clinical Trials for Anamorelin

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00622193 ↗	Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer	Completed	Helsinn Therapeutics (U.S.), Inc	Phase 2	The purpose of this study is to evaluate doses of anamorelin for safety and efficacy in patients with non-small cell lung cancer.
NCT01387269 ↗	Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)	Completed	Helsinn Therapeutics (U.S.), Inc	Phase 3	The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.
NCT01387282 ↗	Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2)	Completed	Helsinn Therapeutics (U.S.), Inc	Phase 3	The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.
NCT01395914 ↗	Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)	Completed	Helsinn Therapeutics (U.S.), Inc	Phase 3	The administration of Anamorelin HCl in patients with Non-Small Cell Lung Cancer-Cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.
NCT01505764 ↗	The Role of Ghrelin in Cancer Cachexia	Terminated	Helsinn Therapeutics (U.S.), Inc	Phase 2	Cancer is often coupled with a condition called cachexia. In this condition, individuals continue to lose weight and lean body mass, which means their muscles are getting smaller and weaker. Studies have shown that cancer patients who are losing weight often are responding poorly to chemotherapy, are at greater risk of infection and have a reduced life expectancy. Also, people may not want to eat. To date, there are no approved treatments available for this condition. This study is going to study the benefits of the use of the study drug, Anamorelin hydrochloride (HCl) in treatment or prevention of cachexia associated with cancer. Studies done before with the study drug have shown that the drug can help the cachectic condition. The purpose of this research study is to evaluate the effectiveness of Anamorelin HCl compared to placebo on body composition (amount of cell mass, fat, muscle, etc.) including measurements of body potassium and nitrogen stores. In addition to the above, the study will also assess the effect of the study drug on handgrip strength, body weight, lean muscle mass, quality of life, appetite & food intake, certain blood markers, energy expenditure (the amount of energy participants burn), functional performance, safety and tolerability of Anamorelin HCl.
NCT01505764 ↗	The Role of Ghrelin in Cancer Cachexia	Terminated	VA Office of Research and Development	Phase 2	Cancer is often coupled with a condition called cachexia. In this condition, individuals continue to lose weight and lean body mass, which means their muscles are getting smaller and weaker. Studies have shown that cancer patients who are losing weight often are responding poorly to chemotherapy, are at greater risk of infection and have a reduced life expectancy. Also, people may not want to eat. To date, there are no approved treatments available for this condition. This study is going to study the benefits of the use of the study drug, Anamorelin hydrochloride (HCl) in treatment or prevention of cachexia associated with cancer. Studies done before with the study drug have shown that the drug can help the cachectic condition. The purpose of this research study is to evaluate the effectiveness of Anamorelin HCl compared to placebo on body composition (amount of cell mass, fat, muscle, etc.) including measurements of body potassium and nitrogen stores. In addition to the above, the study will also assess the effect of the study drug on handgrip strength, body weight, lean muscle mass, quality of life, appetite & food intake, certain blood markers, energy expenditure (the amount of energy participants burn), functional performance, safety and tolerability of Anamorelin HCl.

Clinical Trial Conditions for Anamorelin

Condition Name

Condition Name for
Intervention	Trials
Cachexia	3
Non-Small Cell Lung Cancer	3
Non Small Cell Lung Cancer	2
Cachexia; Cancer	2

Condition MeSH

Condition MeSH for
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	7
Lung Neoplasms	6
Cachexia	6
Wasting Syndrome	4

Clinical Trial Locations for Anamorelin

Trials by Country

Trials by Country for
Location	Trials
United States	85
Romania	7
Ukraine	7
Australia	7
Italy	6

Trials by US State

Trials by US State for
Location	Trials
Texas	6
New York	5
California	5
Massachusetts	5
Florida	5

Clinical Trial Progress for Anamorelin

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	5
Phase 2/Phase 3	1
Phase 2	4

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	4
Recruiting	3
Active, not recruiting	1

Clinical Trial Sponsors for Anamorelin

Sponsor Name

Sponsor Name for
Sponsor	Trials
Helsinn Therapeutics (U.S.), Inc	5
Helsinn Healthcare SA	4
National Cancer Institute (NCI)	2

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	9
Other	5
NIH	3