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

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ClinicalTrials.gov Identifier: NCT01387269

Recruitment Status : Completed

First Posted : July 4, 2011

Results First Posted : July 11, 2017

Last Update Posted : October 27, 2017

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Sponsor:

Information provided by (Responsible Party):

Helsinn Therapeutics (U.S.), Inc

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions	Cachexia Non-Small Cell Lung Cancer
Interventions	Drug: Anamorelin HCl Drug: Placebo
Enrollment	484

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 Details	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 a...	Placebo tablets identical in appear...
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 ^[1]	231	121
Not Completed	92	40
Reason Not Completed
Death	38	20
Other	8	7
Unrelated AE	12	3
Withdrawal by patient	32	10
Study drug-related AE	1	0
Lost to Follow-up	1	0
[1] A patient was considered to have completed the study if the patient completed Week 12/Day 85 Visit.

Baseline Characteristics

Arm/Group Title		Anamorelin HCl	Placebo	Total
Arm/Group Description		Active drug; 100 mg tablets; oral a...	Placebo tablets identical in appear...	Total of all reporting groups
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 Number of Baseline Participants		323	161	484
Baseline Analysis Population Description		...
Baseline Analysis Population Description		The intent-to-treat (ITT) Population included all randomized patients.
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	323 participants	161 participants	484 participants
	<=18 years	0 0.0%	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 Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	323 participants	161 participants	484 participants
	Female	76 23.5%	40 24.8%	116 24.0%
	Male	247 76.5%	121 75.2%	368 76.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	323 participants	161 participants	484 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	1 0.3%	0 0.0%	1 0.2%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	1 0.3%	0 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%	0 0.0%
	Unknown or Not Reported	2 0.6%	2 1.2%	4 0.8%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	323 participants	161 participants	484 participants
Russian Federation		8	4	12
Serbia		10	3	13
Ukraine		133	66	199
Belarus		15	9	24
United States		26	11	37
Canada		9	6	15
Netherlands		2	0	2
Poland		48	26	74
Slovenia		5	4	9
Spain		13	3	16
Belgium		11	4	15
Czech Republic		16	11	27
France		8	6	14
Germany		10	3	13
Italy		9	5	14
Geographic region Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	323 participants	161 participants	484 participants
	North America	35 10.8%	17 10.6%	52 10.7%
	West Europe	122 37.8%	62 38.5%	184 38.0%
	East Europe + Russia	166 51.4%	82 50.9%	248 51.2%
	Australia	0 0.0%	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...
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 a...	Placebo tablets identical in appear...
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.
Overall Number of Participants Analyzed	316	158
Median (95% Confidence Interval) Unit of Measure: kg
	0.99 (0.61 to 1.36)	-0.47 (-1.00 to 0.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anamorelin HCl, Placebo
	Comments	Superiority analysis
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	[Not Specified]
	Method	Wilcoxon rank sum test
	Comments	[Not Specified]

2.Primary Outcome


Title	Change in Handgrip Strength
Description	Change in Handgrip Strength (HGS) of the non-dominant hand from baseli...
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


Arm/Group Title	Anamorelin HCl	Placebo
Arm/Group Description:	Active drug; 100 mg tablets; oral a...	Placebo tablets identical in appear...
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.
Overall Number of Participants Analyzed	316	158
Median (95% Confidence Interval) Unit of Measure: kg
	-1.10 (-1.69 to -0.40)	-1.58 (-2.99 to -1.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anamorelin HCl, Placebo
	Comments	Superiority analysis
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.1475
	Comments	[Not Specified]
	Method	Wilcoxon rank sum test
	Comments	[Not Specified]

3.Secondary Outcome


Title	Change in A/CS Domain Score
Description	The Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Addit...
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 a...	Placebo tablets identical in appear...
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.
Overall Number of Participants Analyzed	284	141
Least Squares Mean (Standard Error) Unit of Measure: 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	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0004
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

4.Secondary Outcome


Title	Change in FACIT-F Fatigue Domain Score
Description	The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)...
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 a...	Placebo tablets identical in appear...
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.
Overall Number of Participants Analyzed	284	141
Least Squares Mean (Standard Error) Unit of Measure: 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	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0544
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

5.Secondary Outcome


Title	Change in Body Weight
Description	Change in body weight (BW) from baseline overall (i.e., over 12 weeks)...
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 a...	Placebo tablets identical in appear...
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.
Overall Number of Participants Analyzed	284	141
Least Squares Mean (Standard Error) Unit of Measure: 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	[Not Specified]

Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

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 a...		Placebo tablets identical in appear...
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 (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	Anamorelin HCl		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	82/320 (25.62%)		48/161 (29.81%)
Blood and lymphatic system disorders
Anaemia ^† 1	5/320 (1.56%)	6	3/161 (1.86%)	3
Febrile neutropenia ^† 1	0/320 (0.00%)	0	3/161 (1.86%)	3
Neutropenia ^† 1	2/320 (0.63%)	2	1/161 (0.62%)	1
Pancytopenia ^† 1	3/320 (0.94%)	3	1/161 (0.62%)	1
Thrombocytopenia ^† 1	1/320 (0.31%)	1	3/161 (1.86%)	3
Leukocytosis ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Idiopathic thrombocytopenic purpura ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Leukopenia ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Cardiac disorders
Pericardial effusion ^† 1	2/320 (0.63%)	2	1/161 (0.62%)	1
Arrhythmia ^† 1	0/320 (0.00%)	0	1/161 (0.62%)	1
Cardiac arrest ^† 1	0/320 (0.00%)	0	2/161 (1.24%)	2
Myocardial infarction ^† 1	0/320 (0.00%)	0	1/161 (0.62%)	1
Atrial flutter ^† 1	0/320 (0.00%)	0	1/161 (0.62%)	1
Cardiopulmonary failure ^† 1	0/320 (0.00%)	0	1/161 (0.62%)	1
Atrial fibrillation ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Ischaemic cardiomyopathy ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Gastrointestinal disorders
Constipation ^† 1	1/320 (0.31%)	1	1/161 (0.62%)	1
Rectal haemorrhage ^† 1	0/320 (0.00%)	0	1/161 (0.62%)	1
Gastrointestinal ulcer ^† 1	1/320 (0.31%)	1	1/161 (0.62%)	1
Dysphagia ^† 1	1/320 (0.31%)	1	1/161 (0.62%)	1
Gastrointestinal haemorrhage ^† 1	0/320 (0.00%)	0	1/161 (0.62%)	1
Oesophagitis ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Colitis ischaemic ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Abdominal pain ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Nausea ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Vomiting ^† 1	2/320 (0.63%)	2	0/161 (0.00%)	0
Gastric haemorrhage ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Small intestinal obstruction ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
General disorders
Death ^† 1	2/320 (0.63%)	2	1/161 (0.62%)	1
General physical health deterioration ^† 1	3/320 (0.94%)	3	1/161 (0.62%)	1
Pain ^† 1	0/320 (0.00%)	0	1/161 (0.62%)	1
Pyrexia ^† 1	1/320 (0.31%)	1	1/161 (0.62%)	1
Asthenia ^† 1	1/320 (0.31%)	1	1/161 (0.62%)	1
Fatigue ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Hepatobiliary disorders
Hepatic failure ^† 1	0/320 (0.00%)	0	1/161 (0.62%)	1
Cholecystitis ^† 1	0/320 (0.00%)	0	1/161 (0.62%)	1
Infections and infestations
Pneumonia ^† 1	4/320 (1.25%)	4	4/161 (2.48%)	5
Cellulitis ^† 1	0/320 (0.00%)	0	1/161 (0.62%)	1
Urinary tract infection ^† 1	1/320 (0.31%)	1	1/161 (0.62%)	1
Respiratory tract infection ^† 1	0/320 (0.00%)	0	1/161 (0.62%)	1
Bronchopulmonary aspergillosis ^† 1	0/320 (0.00%)	0	1/161 (0.62%)	1
Staphylococcal infection ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Lung infection ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Gastroenteritis ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Lobar pneumonia ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Sepsis ^† 1	2/320 (0.63%)	2	0/161 (0.00%)	0
Oral candidiasis ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Bronchopneumonia ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Osteomyelitis acute ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Hepatitis C ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Metabolism and nutrition disorders
Hyperglycaemia ^† 1	3/320 (0.94%)	3	0/161 (0.00%)	0
Failure to thrive ^† 1	0/320 (0.00%)	0	2/161 (1.24%)	2
Decreased appetite ^† 1	1/320 (0.31%)	1	1/161 (0.62%)	1
Dehydration ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Hypocalcaemia ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Diabetes mellitus ^† 1	2/320 (0.63%)	2	0/161 (0.00%)	0
Musculoskeletal and connective tissue disorders
Back pain ^† 1	1/320 (0.31%)	1	1/161 (0.62%)	1
Musculoskeletal chest pain ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Bone pain ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression ^† 1	24/320 (7.50%)	24	12/161 (7.45%)	12
Nervous system disorders
Presyncope ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Ischaemic stroke ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Psychiatric disorders
Mental status changes ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Agitation ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Renal and urinary disorders
Urinary tract obstruction ^† 1	0/320 (0.00%)	0	1/161 (0.62%)	1
Renal failure ^† 1	0/320 (0.00%)	0	1/161 (0.62%)	1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease ^† 1	4/320 (1.25%)	5	3/161 (1.86%)	4
Pulmonary embolism ^† 1	3/320 (0.94%)	3	0/161 (0.00%)	0
Pulmonary haemorrhage ^† 1	3/320 (0.94%)	3	1/161 (0.62%)	1
Dyspnoea ^† 1	0/320 (0.00%)	0	2/161 (1.24%)	3
Respiratory failure ^† 1	0/320 (0.00%)	0	2/161 (1.24%)	2
Bronchopulmonary hemorrhage ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Haemoptysis ^† 1	0/320 (0.00%)	0	1/161 (0.62%)	1
Epistaxis ^† 1	2/320 (0.63%)	2	0/161 (0.00%)	0
Dyspnoea exertional ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Pleuritic pain ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Vascular disorders
Deep vein thrombosis ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Iliac artery occlusion ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
Inferior vena caval occlusion ^† 1	1/320 (0.31%)	1	0/161 (0.00%)	0
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 14.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Anamorelin HCl		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	182/320 (56.88%)		84/161 (52.17%)
Blood and lymphatic system disorders
Anaemia ^† 1	119/320 (37.19%)	179	66/161 (40.99%)	114
Leukopenia ^† 1	16/320 (5.00%)	17	10/161 (6.21%)	10
Neutropenia ^† 1	28/320 (8.75%)	34	22/161 (13.66%)	34
Thrombocytopenia ^† 1	29/320 (9.06%)	42	23/161 (14.29%)	34
Gastrointestinal disorders
Diarrhoea ^† 1	17/320 (5.31%)	21	9/161 (5.59%)	9
Nausea ^† 1	29/320 (9.06%)	44	15/161 (9.32%)	21
Vomiting ^† 1	25/320 (7.81%)	27	8/161 (4.97%)	8
General disorders
Asthenia ^† 1	19/320 (5.94%)	23	9/161 (5.59%)	10
Fatigue ^† 1	25/320 (7.81%)	28	13/161 (8.07%)	15
Pyrexia ^† 1	15/320 (4.69%)	16	1/161 (0.62%)	1
Investigations
Alanine aminotransferase increased ^† 1	50/320 (15.63%)	78	14/161 (8.70%)	20
Aspartate aminotransferase increased ^† 1	37/320 (11.56%)	52	15/161 (9.32%)	21
Blood alkaline phosphatase increased ^† 1	34/320 (10.63%)	40	10/161 (6.21%)	14
Platelet count decreased ^† 1	14/320 (4.38%)	30	10/161 (6.21%)	16
Metabolism and nutrition disorders
Decreased appetite ^† 1	13/320 (4.06%)	15	8/161 (4.97%)	8
Hyperglycaemia ^† 1	35/320 (10.94%)	41	10/161 (6.21%)	11
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	14/320 (4.38%)	14	8/161 (4.97%)	9
Dyspnoea ^† 1	19/320 (5.94%)	24	11/161 (6.83%)	13
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 14.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Richard K. Bourne, Ph.D.
Organization:	Helsinn Therapeutics (US), Inc.
Phone:	732-603-2852
EMail:	richard.bourne@helsinn.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Currow D, Temel JS, Abernethy A, Milanowski J, Friend J, Fearon KC. ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia. Ann Oncol. 2017 Aug 1;28(8):1949-1956. doi: 10.1093/annonc/mdx192.

Temel JS, Abernethy AP, Currow DC, Friend J, Duus EM, Yan Y, Fearon KC. Anamorelin in patients with non-small-cell lung cancer and cachexia (ROMANA 1 and ROMANA 2): results from two randomised, double-blind, phase 3 trials. Lancet Oncol. 2016 Apr;17(4):519-531. doi: 10.1016/S1470-2045(15)00558-6. Epub 2016 Feb 20.

Layout table for additonal information

Responsible Party:	Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier:	NCT01387269
Other Study ID Numbers:	HT-ANAM-301
First Submitted:	June 30, 2011
First Posted:	July 4, 2011
Results First Submitted:	March 15, 2017
Results First Posted:	July 11, 2017
Last Update Posted:	October 27, 2017

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