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Generated: June 27, 2019

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CLINICAL TRIALS PROFILE FOR ANAMORELIN

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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.
NCT03035409 Effects of Anamorelin on Cancer-Related-Fatigue Recruiting Helsinn Healthcare SA Phase 2 The goal of this clinical research study is to learn if anamorelin can help to decrease cancer-related fatigue in patients with advanced cancer. The safety of this drug in combination with physical activity will also be studied.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Anamorelin

Condition Name

Condition Name for
Intervention Trials
Non-Small Cell Lung Cancer 3
Cachexia 3
Treatment of Malignancy Associated Weight Loss or Anorexia in Patients With NSCLC 2
Non-Small Cell Lung Carcinoma 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Carcinoma, Non-Small-Cell Lung 7
Lung Neoplasms 4
Cachexia 4
Anorexia 3
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Clinical Trial Locations for Anamorelin

Trials by Country

Trials by Country for
Location Trials
United States 48
Canada 6
Australia 5
India 4
Russian Federation 3
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Trials by US State

Trials by US State for
Location Trials
Texas 5
Ohio 3
New York 3
California 3
South Carolina 3
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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 3
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 4
Not yet recruiting 3
Terminated 1
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Clinical Trial Sponsors for Anamorelin

Sponsor Name

Sponsor Name for
Sponsor Trials
Helsinn Therapeutics (U.S.), Inc 5
Helsinn Healthcare SA 3
M.D. Anderson Cancer Center 2
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 8
Other 2
U.S. Fed 1
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