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

• Sponsor: Helsinn Therapeutics (U.S.), Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01387269
• Collaborator: (none)
• Enrollment: 484
• Locations: 60
• Arms: 2
• Duration (Months): 43.1
• Patients Per Site: 8.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cachexia; Non-Small Cell Lung Cancer	Drug: Anamorelin HCl; Drug: Placebo	Phase 3

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 484 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 100 mg QD Anamorelin HCL 100 mg will be administered daily	Drug: Anamorelin HCl; Anamorelin HCl will be orally administered daily at least one hour before meal
Placebo Comparator: Placebo Placebo tablets identical in appearance to active tablets; oral administration once daily	Drug: Placebo; Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before meal

Outcome Measures

Primary Outcome Measures

1. Change in Lean Body Mass [Change in Lean Body Mass from Baseline Over 12 Weeks]

   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.

2. Change in Handgrip Strength [Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks]

   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.

Secondary Outcome Measures

1. Change in A/CS Domain Score [Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks]

   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).

2. Change in FACIT-F Fatigue Domain Score [Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks]

   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).

3. Change in Body Weight [Change in Body Weight from Baseline Over 12 Weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Documented diagnosis of unresectable Stage III or Stage IV NSCLC

• Patients may be receiving maintenance chemotherapy

• Patients planning to initiate a new chemotherapy and/or radiation therapy regimen may do so only within ± 14 days of randomization

• Patients may have completed a chemotherapy and/or radiation therapy and/or have no plan to initiate a new regimen within 12 weeks from randomization; at least 14 days must elapse from the completion of the chemotherapy and/or radiation therapy prior to randomization

• Involuntary weight loss of ≥5% body weight within 6 months prior to screening or a screening body mass index (BMI) <20 kg/m2

• Body mass index ≤30 kg/m2

• Life expectancy of >4 months at time of screening

• ECOG performance status ≤2

• Adequate hepatic function, defined as AST and ALT levels ≤5 x upper limit of normal

• Adequate renal function, defined as creatinine ≤2 x upper limit of normal, or calculated creatinine clearance >30 ml/minute

• Ability to understand and comply with the procedures for the HGS evaluation

• If a woman of childbearing potential or a fertile man, he/she must agree to use an effective form of contraception during the study and for 30 days following the last dose of study drug (an effective form of contraception is abstinence, a hormonal contraceptive, or a double-barrier method)

• Must be willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures

Exclusion Criteria:

• Other forms of lung cancer (e.g., small cell, mesothelioma)

• Women who are pregnant or breast-feeding

• Known HIV, hepatitis (B&C), or active tuberculosis

• Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization; patients must be well recovered from acute effects of surgery prior to screening; patients should not have plans to undergo major surgical procedures during the treatment period

• Currently taking prescription medications intended to increase appetite or treat weight loss; these include, but are not limited to, testosterone, androgenic compounds, megestrol acetate, methylphenidate, and dronabinol

• Inability to readily swallow oral tablets; patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded

• Has an active, uncontrolled infection

• Has uncontrolled diabetes mellitus

• Has untreated clinically relevant hypothyroidism

• Has known or symptomatic brain metastases

• Receiving strong CYP3A4 inhibitors within 14 days of randomization

• Receiving tube feedings or parenteral nutrition (either total or partial); patients must have discontinued these treatments for at least 6 weeks prior to Day 1, and throughout the study duration

• Other clinical diagnosis, ongoing or intercurrent illness that in the Investigator's opinion would prevent the patient's participation

• Has had previous exposure to Anamorelin HCl

• Patients actively receiving a concurrent investigational agent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Fullerton	California	United States
2		Glendale	California	United States
3		La Jolla	California	United States
4		Riverside	California	United States
5		Orange City	Florida	United States
6		Quincy	Illinois	United States
7		Indianapolis	Indiana	United States
8		Louisville	Kentucky	United States
9		Boston	Massachusetts	United States
10		Northport	New York	United States
11		Cincinnati	Ohio	United States
12		Houston	Texas	United States
13		Brest		Belarus
14		Lesnoy		Belarus
15		Minsk		Belarus
16		Antwerpen		Belgium
17		Brussels		Belgium
18		Genk		Belgium
19		Liege		Belgium
20		Edmonton	Alberta	Canada
21		Sault Ste. Marie	Ontario	Canada
22		Toronto	Ontario	Canada
23		Montreal	Quebec	Canada
24		Benesov		Czechia
25		Brno		Czechia
26		Hlucin		Czechia
27		Liberec		Czechia
28		Nymburk		Czechia
29		Lyon Cedex		France
30		Villejuif cedex		France
31		Berlin		Germany
32		Grosshansdorf		Germany
33		Halle		Germany
34		Minden		Germany
35		Budapest		Hungary
36		Placenza		Italy
37		Rozzano		Italy
38		Amsterdam		Netherlands
39		Goes		Netherlands
40		Maastricht		Netherlands
41		Nieuwegein		Netherlands
42		Grudziadz		Poland
43		Katowice		Poland
44		Krakow		Poland
45		Lublin		Poland
46		Ekaterinburg		Russian Federation
47		St. Petersburg		Russian Federation
48		Belgrade		Serbia
49		Sremska Kamenica		Serbia
50		Golnik		Slovenia
51		Ljubljana		Slovenia
52		Barcelona		Spain
53		Cordoba		Spain
54		Sevilla		Spain
55		Valencia		Spain
56		Dnipropetrovsk		Ukraine
57		Donetsk		Ukraine
58		Kharkiv		Ukraine
59		Kyiv		Ukraine
60		Zaporizhzhya		Ukraine

Sponsors and Collaborators

• Helsinn Therapeutics (U.S.), Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Helsinn Therapeutics (U.S.), Inc
• ClinicalTrials.gov Identifier: NCT01387269
• Other Study ID Numbers: HT-ANAM-301
• First Posted: Jul 4, 2011
• Last Update Posted: Oct 27, 2017
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Wasting Syndrome; Cachexia

Study Results

Participant Flow

Recruitment Details	Approximately 477 patients with advanced NSCLC-C (defined as unresectable Stage III and Stage IV and a weight loss of ≥ 5% body weight within 6 months prior to screening or a screening body mass index [BMI] < 20 kg/m2) were to be randomized 2:1 to anamorelin HCl 100 mg or placebo.
Pre-assignment Detail	Central randomization stratified patients by geographic region, by chemotherapy and/or radiation therapy status and by weight loss over prior 6 months.

Arm/Group Title	Anamorelin HCl	Placebo
Arm/Group Description	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.
Period Title: Overall Study
STARTED	323	161
ITT Population	323	161
MITT Population	284	141
Safety Population	320	161
COMPLETED	231	121
NOT COMPLETED	92	40

Baseline Characteristics

Arm/Group Title	Anamorelin HCl	Placebo	Total
Arm/Group Description	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.	Total of all reporting groups
Overall Participants	323	161	484
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	215 66.6%	105 65.2%	320 66.1%
>=65 years	108 33.4%	56 34.8%	164 33.9%
Sex: Female, Male (Count of Participants)
Female	76 23.5%	40 24.8%	116 24%
Male	247 76.5%	121 75.2%	368 76%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 0.3%	0 0%	1 0.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 0.3%	0 0%	1 0.2%
White	319 98.8%	159 98.8%	478 98.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 0.6%	2 1.2%	4 0.8%
Region of Enrollment (participants) [Number]
Russian Federation	8 2.5%	4 2.5%	12 2.5%
Serbia	10 3.1%	3 1.9%	13 2.7%
Ukraine	133 41.2%	66 41%	199 41.1%
Belarus	15 4.6%	9 5.6%	24 5%
United States	26 8%	11 6.8%	37 7.6%
Canada	9 2.8%	6 3.7%	15 3.1%
Netherlands	2 0.6%	0 0%	2 0.4%
Poland	48 14.9%	26 16.1%	74 15.3%
Slovenia	5 1.5%	4 2.5%	9 1.9%
Spain	13 4%	3 1.9%	16 3.3%
Belgium	11 3.4%	4 2.5%	15 3.1%
Czech Republic	16 5%	11 6.8%	27 5.6%
France	8 2.5%	6 3.7%	14 2.9%
Germany	10 3.1%	3 1.9%	13 2.7%
Italy	9 2.8%	5 3.1%	14 2.9%
Geographic region (Count of Participants)
North America	35 10.8%	17 10.6%	52 10.7%
West Europe	122 37.8%	62 38.5%	184 38%
East Europe + Russia	166 51.4%	82 50.9%	248 51.2%
Australia	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change in Lean Body Mass
Description	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.
Time Frame	Change in Lean Body Mass from Baseline Over 12 Weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Anamorelin HCl	Placebo
Arm/Group Description	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.
Measure Participants	316	158
Median (95% Confidence Interval) [kg]	0.99	-0.47

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anamorelin HCl, Placebo
	Comments	Superiority analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	Wilcoxon rank sum test
	Comments

2. Primary Outcome

Title	Change in Handgrip Strength
Description	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.
Time Frame	Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Anamorelin HCl	Placebo
Arm/Group Description	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.
Measure Participants	316	158
Median (95% Confidence Interval) [kg]	-1.10	-1.58

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anamorelin HCl, Placebo
	Comments	Superiority analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1475
	Comments
	Method	Wilcoxon rank sum test
	Comments

3. Secondary Outcome

Title	Change in A/CS Domain Score
Description	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).
Time Frame	Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat Population

Arm/Group Title	Anamorelin HCl	Placebo
Arm/Group Description	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.
Measure Participants	284	141
Least Squares Mean (Standard Error) [scores on a scale]	4.12 (0.752)	1.92 (0.805)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anamorelin HCl, Placebo
	Comments	Superiority analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0004
	Comments
	Method	Mixed Models Analysis
	Comments

4. Secondary Outcome

Title	Change in FACIT-F Fatigue Domain Score
Description	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).
Time Frame	Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat Population

Arm/Group Title	Anamorelin HCl	Placebo
Arm/Group Description	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.
Measure Participants	284	141
Least Squares Mean (Standard Error) [scores on a scale]	0.26 (0.886)	-1.19 (0.933)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anamorelin HCl, Placebo
	Comments	Superiority analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0544
	Comments
	Method	Mixed Models Analysis
	Comments

5. Secondary Outcome

Title	Change in Body Weight
Description	Change in body weight (BW) from baseline overall (i.e., over 12 weeks) for the MITT Population.
Time Frame	Change in Body Weight from Baseline Over 12 Weeks

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat Population

Arm/Group Title	Anamorelin HCl	Placebo
Arm/Group Description	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.
Measure Participants	284	141
Least Squares Mean (Standard Error) [kg]	2.20 (0.326)	0.14 (0.363)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anamorelin HCl, Placebo
	Comments	Superiority analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	Mixed Models Analysis
	Comments

Adverse Events

Time Frame	Adverse events that occurred during the clinical trial, commenced with the first dose of study drug through the 28 day post-treatment follow-up visit.
Adverse Event Reporting Description	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.
Arm/Group Title	Anamorelin HCl		Placebo
Arm/Group Description	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.
All Cause Mortality
	Anamorelin HCl		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Anamorelin HCl		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	82/320 (25.6%)		48/161 (29.8%)
Blood and lymphatic system disorders
Anaemia	5/320 (1.6%)	6	3/161 (1.9%)	3
Febrile neutropenia	0/320 (0%)	0	3/161 (1.9%)	3
Neutropenia	2/320 (0.6%)	2	1/161 (0.6%)	1
Pancytopenia	3/320 (0.9%)	3	1/161 (0.6%)	1
Thrombocytopenia	1/320 (0.3%)	1	3/161 (1.9%)	3
Leukocytosis	1/320 (0.3%)	1	0/161 (0%)	0
Idiopathic thrombocytopenic purpura	1/320 (0.3%)	1	0/161 (0%)	0
Leukopenia	1/320 (0.3%)	1	0/161 (0%)	0
Cardiac disorders
Pericardial effusion	2/320 (0.6%)	2	1/161 (0.6%)	1
Arrhythmia	0/320 (0%)	0	1/161 (0.6%)	1
Cardiac arrest	0/320 (0%)	0	2/161 (1.2%)	2
Myocardial infarction	0/320 (0%)	0	1/161 (0.6%)	1
Atrial flutter	0/320 (0%)	0	1/161 (0.6%)	1
Cardiopulmonary failure	0/320 (0%)	0	1/161 (0.6%)	1
Atrial fibrillation	1/320 (0.3%)	1	0/161 (0%)	0
Ischaemic cardiomyopathy	1/320 (0.3%)	1	0/161 (0%)	0
Gastrointestinal disorders
Constipation	1/320 (0.3%)	1	1/161 (0.6%)	1
Rectal haemorrhage	0/320 (0%)	0	1/161 (0.6%)	1
Gastrointestinal ulcer	1/320 (0.3%)	1	1/161 (0.6%)	1
Dysphagia	1/320 (0.3%)	1	1/161 (0.6%)	1
Gastrointestinal haemorrhage	0/320 (0%)	0	1/161 (0.6%)	1
Oesophagitis	1/320 (0.3%)	1	0/161 (0%)	0
Colitis ischaemic	1/320 (0.3%)	1	0/161 (0%)	0
Abdominal pain	1/320 (0.3%)	1	0/161 (0%)	0
Nausea	1/320 (0.3%)	1	0/161 (0%)	0
Vomiting	2/320 (0.6%)	2	0/161 (0%)	0
Gastric haemorrhage	1/320 (0.3%)	1	0/161 (0%)	0
Small intestinal obstruction	1/320 (0.3%)	1	0/161 (0%)	0
General disorders
Death	2/320 (0.6%)	2	1/161 (0.6%)	1
General physical health deterioration	3/320 (0.9%)	3	1/161 (0.6%)	1
Pain	0/320 (0%)	0	1/161 (0.6%)	1
Pyrexia	1/320 (0.3%)	1	1/161 (0.6%)	1
Asthenia	1/320 (0.3%)	1	1/161 (0.6%)	1
Fatigue	1/320 (0.3%)	1	0/161 (0%)	0
Hepatobiliary disorders
Hepatic failure	0/320 (0%)	0	1/161 (0.6%)	1
Cholecystitis	0/320 (0%)	0	1/161 (0.6%)	1
Infections and infestations
Pneumonia	4/320 (1.3%)	4	4/161 (2.5%)	5
Cellulitis	0/320 (0%)	0	1/161 (0.6%)	1
Urinary tract infection	1/320 (0.3%)	1	1/161 (0.6%)	1
Respiratory tract infection	0/320 (0%)	0	1/161 (0.6%)	1
Bronchopulmonary aspergillosis	0/320 (0%)	0	1/161 (0.6%)	1
Staphylococcal infection	1/320 (0.3%)	1	0/161 (0%)	0
Lung infection	1/320 (0.3%)	1	0/161 (0%)	0
Gastroenteritis	1/320 (0.3%)	1	0/161 (0%)	0
Lobar pneumonia	1/320 (0.3%)	1	0/161 (0%)	0
Sepsis	2/320 (0.6%)	2	0/161 (0%)	0
Oral candidiasis	1/320 (0.3%)	1	0/161 (0%)	0
Bronchopneumonia	1/320 (0.3%)	1	0/161 (0%)	0
Osteomyelitis acute	1/320 (0.3%)	1	0/161 (0%)	0
Hepatitis C	1/320 (0.3%)	1	0/161 (0%)	0
Metabolism and nutrition disorders
Hyperglycaemia	3/320 (0.9%)	3	0/161 (0%)	0
Failure to thrive	0/320 (0%)	0	2/161 (1.2%)	2
Decreased appetite	1/320 (0.3%)	1	1/161 (0.6%)	1
Dehydration	1/320 (0.3%)	1	0/161 (0%)	0
Hypocalcaemia	1/320 (0.3%)	1	0/161 (0%)	0
Diabetes mellitus	2/320 (0.6%)	2	0/161 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	1/320 (0.3%)	1	1/161 (0.6%)	1
Musculoskeletal chest pain	1/320 (0.3%)	1	0/161 (0%)	0
Bone pain	1/320 (0.3%)	1	0/161 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression	24/320 (7.5%)	24	12/161 (7.5%)	12
Nervous system disorders
Presyncope	1/320 (0.3%)	1	0/161 (0%)	0
Ischaemic stroke	1/320 (0.3%)	1	0/161 (0%)	0
Psychiatric disorders
Mental status changes	1/320 (0.3%)	1	0/161 (0%)	0
Agitation	1/320 (0.3%)	1	0/161 (0%)	0
Renal and urinary disorders
Urinary tract obstruction	0/320 (0%)	0	1/161 (0.6%)	1
Renal failure	0/320 (0%)	0	1/161 (0.6%)	1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	4/320 (1.3%)	5	3/161 (1.9%)	4
Pulmonary embolism	3/320 (0.9%)	3	0/161 (0%)	0
Pulmonary haemorrhage	3/320 (0.9%)	3	1/161 (0.6%)	1
Dyspnoea	0/320 (0%)	0	2/161 (1.2%)	3
Respiratory failure	0/320 (0%)	0	2/161 (1.2%)	2
Bronchopulmonary hemorrhage	1/320 (0.3%)	1	0/161 (0%)	0
Haemoptysis	0/320 (0%)	0	1/161 (0.6%)	1
Epistaxis	2/320 (0.6%)	2	0/161 (0%)	0
Dyspnoea exertional	1/320 (0.3%)	1	0/161 (0%)	0
Pleuritic pain	1/320 (0.3%)	1	0/161 (0%)	0
Vascular disorders
Deep vein thrombosis	1/320 (0.3%)	1	0/161 (0%)	0
Iliac artery occlusion	1/320 (0.3%)	1	0/161 (0%)	0
Inferior vena caval occlusion	1/320 (0.3%)	1	0/161 (0%)	0
Other (Not Including Serious) Adverse Events
	Anamorelin HCl		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	182/320 (56.9%)		84/161 (52.2%)
Blood and lymphatic system disorders
Anaemia	119/320 (37.2%)	179	66/161 (41%)	114
Leukopenia	16/320 (5%)	17	10/161 (6.2%)	10
Neutropenia	28/320 (8.8%)	34	22/161 (13.7%)	34
Thrombocytopenia	29/320 (9.1%)	42	23/161 (14.3%)	34
Gastrointestinal disorders
Diarrhoea	17/320 (5.3%)	21	9/161 (5.6%)	9
Nausea	29/320 (9.1%)	44	15/161 (9.3%)	21
Vomiting	25/320 (7.8%)	27	8/161 (5%)	8
General disorders
Asthenia	19/320 (5.9%)	23	9/161 (5.6%)	10
Fatigue	25/320 (7.8%)	28	13/161 (8.1%)	15
Pyrexia	15/320 (4.7%)	16	1/161 (0.6%)	1
Investigations
Alanine aminotransferase increased	50/320 (15.6%)	78	14/161 (8.7%)	20
Aspartate aminotransferase increased	37/320 (11.6%)	52	15/161 (9.3%)	21
Blood alkaline phosphatase increased	34/320 (10.6%)	40	10/161 (6.2%)	14
Platelet count decreased	14/320 (4.4%)	30	10/161 (6.2%)	16
Metabolism and nutrition disorders
Decreased appetite	13/320 (4.1%)	15	8/161 (5%)	8
Hyperglycaemia	35/320 (10.9%)	41	10/161 (6.2%)	11
Respiratory, thoracic and mediastinal disorders
Cough	14/320 (4.4%)	14	8/161 (5%)	9
Dyspnoea	19/320 (5.9%)	24	11/161 (6.8%)	13

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Sponsor intends to publish the complete study results in a timely manner that is appropriate to the project. Separate publication of a portion of the study results by any PI is discouraged.