Nutritional and Metabolic Diseases

All Conditions

Symptoms and General Pathology

Wasting Syndrome

Cachexia

Syndrome

Weight Loss

Body Weight

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.

Anamorelin HCl

Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.

Placebo

Jose M. Garcia, MD PhD

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.

Subjects enrolled in the study will be randomly chosen to receive either Anamorelin HCL at a dose of 100 mg per day for 12 weeks or matching placebo. The chances of receiving anamorelin or placebo are 1 in 2. Which subject receives anamorelin or placebo will be decided at random. Neither the subject nor the study doctor will know which study drug the subject is receiving. The subject will be asked to visit the clinic at Day 1, Day 28, Day 56 and Day 84. There will also be a Day 112 follow-up visit and the medical records will be checked after that to see how the subjects are doing.

The Role of Ghrelin in Cancer Cachexia

lean body mass measured by DEXA. Percentage of change day 84-baseline.

Dominant hand grip strength day 84 - percent change from baseline

Quality of life as assessed using the FACIT-F Patient Reported Outcome assessments - percentage of change day 84-baseline

Appetite measured by a visual analogue scale ASAS. Percentage of change day84-baseline

Functional performance using stair-climbing power day 84 percent change from baseline

Body composition as measured by Total body nitrogen. Percentage of change day 84-baseline

leg extension - percentage of change day 84 to baseline

Helsinn Therapeutics (U.S.), Inc

VA Office of Research and Development

Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.

Arm 1 (Anamorelin HCl)

Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.

Arm 2 (Placebo)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Jose M Garcia MD, PhD, Clinician Investigator

Total Body Potassium.

only two subjects in each group completed this measure.

Lean Mass Measured by Densitometry.

Muscle Strength as Measured by Grip Strength.

Body Weight.

Quality of Life.

Appetite.

Resting Energy Expenditure.

Functional Performance.

only two subjects in each group completed this outcome

Body Composition.

Stair Climbing Power

1-repetition Max. Strength

Anamorelin HCl

Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.

Food Diary Calorie Count

Overall Study

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Anamorelin HCL 100 mg will be administered daily

Placebo tablets identical in appearance to active tablets; oral administration once daily

Anamorelin HCl will be orally administered daily at least one hour before meal

Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before meal

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.

This is a randomized, double-blind, placebo-controlled, multicenter study to assess the safety and efficacy of Anamorelin in patients with non-small cell lung cancer-cachexia (NSCLC-C). The primary efficacy analysis will include the treatment difference in the change in lean body mass and physical function. Pharmacokinetic (PK) samples will also be collected at Day 43 visit for population PK.

Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)

Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C

Change in Lean Body Mass (LBM) from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.

Change in Handgrip Strength (HGS) of the non-dominant hand from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.

The Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Additional Concerns Subscale (A/CS domain) is a 12-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).

The 12-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the A/CS domain ranges from 0 (worst) to 48 (best).

The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue domain is a 13-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).

The 13-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the FACIT-F fatigue domain ranges from 0 (worst) to 52 (best).

Change in body weight (BW) from baseline overall (i.e., over 12 weeks) for the MITT Population.

Adverse events that occurred following the signature of the informed consent, but prior to the first dose of study drug were not reported as adverse events in this trial. The adverse event reporting period also ended if the patient began an alternative therapy within 28 days of the last administration of study drug. The Safety Population, defined as all randomized patients who received any study drug, was used for all safety analyses.

Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.

Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.

Russian Federation

Serbia

Ukraine

Belarus

Canada

Netherlands

Poland

Slovenia

Spain

Belgium

Czech Republic

France

Germany

Italy

Geographic region

The intent-to-treat (ITT) Population included all randomized patients.

Richard K. Bourne, Ph.D.

Intent-to-Treat Population. Some patients in the ITT population were excluded from the primary LBM/HGS analysis (i.e., multiple imputations/ranking method) if they survived to Week 12 but missed their baseline covariates including LBM, HGS, or ECOG OR had Week 6 and Week 12 outcomes that were outside the visit windows.

Change in Lean Body Mass

Change in Handgrip Strength

Change in A/CS Domain Score

Change in FACIT-F Fatigue Domain Score

Change in Body Weight

Investigational: Anamorelin HCl; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.

Anamorelin HCL 100 mg will be orally administered daily at least 1 hour prior to meal

Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour prior to meal before the first meal of the day.

This is a randomized, double-blind, placebo-controlled, multicenter study to assess the safety and efficacy of Anamorelin in patients with non-small cell lung cancer-cachexia (NSCLC-C). The primary efficacy analysis will include the treatment difference in the change in lean body mass and physical function.

Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2)

United Kingdom

Hungary

Australia

Israel

Anorexia

Signs and Symptoms, Digestive

100 mg anamorelin HCl (administered as 100 mg tablets in the fasted condition)

Placebo oral tablet (administered as matching placebo tablets in the fasted condition)

anamorelin HCl

Placebo (administered as matching placebo tablets in the fasted condition)

Placebo Oral Tablet

Multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of anamorelin HCl. Approximately 316 patients with advanced NSCLC with cachexia will be randomized 1:1 to anamorelin HCl 100 mg or placebo, taken orally once daily (QD) for a total of 24 weeks. Patients will be instructed to take the study drug at least 1 hour before their first meal of the day

Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Mean change in 5-item Anorexia Symptom Subscale

Duration of treatment benefit in weight (≥0).

Duration of treatment benefit in weight (≥ to a predefined threshold).

Duration of treatment benefit in anorexia symptoms (≥0), as measured by the 5-item Anorexia Symptom Subscale.

Duration of treatment benefit in 5-item Anorexia Symptom Subscale (≥ to a predefined threshold).

Mean change in FAACT 12-item A/CS domain.

Helsinn Healthcare SA

placebo

Jennifer Temel, MD

The purpose of this study is to evaluate doses of anamorelin for safety and efficacy in patients with non-small cell lung cancer.

Cancer cachexia is a devastating, often late-stage complication of an underlying malignancy. Despite the significant importance of cancer-related cachexia, treatments are lacking and there are no products approved for this indication. Anamorelin HCl, by virtue of its ghrelin agonist activity, may serve a role in the treatment of cancer cachexia. This placebo controlled dose range study will evaluate the safety and efficacy of anamorelin HCl in patients with non-small cell lung cancer, a cancer associated with a high prevalence of cachexia.

Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Anamorelin HCl Dose Range Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Role of Ghrelin in Cancer Cachexia	NCT01505764	Cancer Cachexia	Anamorelin HCl Placebo	18 Years -	VA Office of Research and Development
Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)	NCT01387269	Cachexia Non-Small Cell ...	Anamorelin HCl Placebo	18 Years -	Helsinn Therapeutics (U.S.), Inc
Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2)	NCT01387282	Cachexia Non-Small Cell ...	Anamorelin HCl Placebo	18 Years -	Helsinn Therapeutics (U.S.), Inc
A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)	NCT03743064	Cachexia; Cance... Non Small Cell ...	anamorelin HCl Placebo Oral Ta...	18 Years -	Helsinn Healthcare SA
Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer	NCT00622193	Carcinoma, Non-...	anamorelin HCl anamorelin HCl placebo	18 Years - 85 Years	Helsinn Therapeutics (U.S.), Inc
The Role of Ghrelin in Cancer Cachexia	NCT01505764	Cancer Cachexia	Anamorelin HCl Placebo	18 Years -	VA Office of Research and Development
Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer	NCT00622193	Carcinoma, Non-...	anamorelin HCl anamorelin HCl placebo	18 Years - 85 Years	Helsinn Therapeutics (U.S.), Inc

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