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Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01395914
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : July 11, 2017
Last Update Posted : September 14, 2017
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 513
Recruitment Details Patients who completed dosing in either of the original trials of anamorelin HCl in the treatment of NSCLC-C (HT-ANAM-301 or HT-ANAM-302) were able to enroll in this study and continue to receive the study drug to which they were assigned, either anamorelin HCl 100 mg or placebo QD for an additional 12 weeks.
Pre-assignment Details The primary purpose of this extension study was to permit patients who completed dosing in the original 12-week trials to have the option of continuing to receive randomized study drug for an additional 12 weeks, to further evaluate the safety and tolerability of anamorelin HCl.
Arm/Group Title Anamorelin HCl Placebo
Hide 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 345 168
ITT Population 345 168
Safety Population 343 167
Completed 273 131
Not Completed 72 37
Reason Not Completed
Unrelated to study drug AE             6             1
Death             23             17
Other             9             3
Withdrawal by patient             27             14
Study drug-related AE             1             0
Lost to Follow-up             6             2
Arm/Group Title Anamorelin HCl Placebo Total
Hide 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 345 168 513
Hide 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 345 participants 168 participants 513 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
236
  68.4%
120
  71.4%
356
  69.4%
>=65 years
109
  31.6%
48
  28.6%
157
  30.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 345 participants 168 participants 513 participants
Female
83
  24.1%
43
  25.6%
126
  24.6%
Male
262
  75.9%
125
  74.4%
387
  75.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 345 participants 168 participants 513 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   0.6%
1
   0.2%
Native Hawaiian or Other Pacific Islander
1
   0.3%
0
   0.0%
1
   0.2%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
344
  99.7%
166
  98.8%
510
  99.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   0.6%
1
   0.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 345 participants 168 participants 513 participants
Poland 107 60 167
Slovenia 0 1 1
Spain 5 2 7
Belgium 2 2 4
Czech Republic 11 3 14
France 1 2 3
Germany 3 0 3
Hungary 39 16 55
Italy 1 0 1
Netherlands 1 0 1
Canada 3 1 4
United States 16 4 20
Belarus 8 6 14
Israel 4 2 6
Serbia 4 2 6
Ukraine 64 33 97
Russian Federation 69 31 100
Australia 7 3 10
1.Primary Outcome
Title Percentage of Participants With Treatment-emergent Adverse Events
Hide Description To Evaluate the Safety and Tolerability of Anamorelin HCl.
Time Frame Over the 12-week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population, defined as patients who received any extension trial study drug.
Arm/Group Title Anamorelin HCl Placebo
Hide 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 343 167
Measure Type: Number
Unit of Measure: percentage of participants
52 56
2.Secondary Outcome
Title Change in Body Weight
Hide Description [Not Specified]
Time Frame Change in body weight from baseline of the original trial through Week 12 of this extension trial.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Anamorelin HCl Placebo
Hide 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 345 168
Least Squares Mean (Standard Error)
Unit of Measure: kg
3.06  (0.631) 0.92  (0.697)
3.Secondary Outcome
Title Change in Handgrip Strength of the Non-Dominant Hand
Hide Description [Not Specified]
Time Frame Change in HGS from baseline of the original trial through Week 12 of this extension trial.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Anamorelin HCl Placebo
Hide 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 345 168
Least Squares Mean (Standard Error)
Unit of Measure: kg
-0.83  (0.929) -0.55  (1.036)
4.Secondary Outcome
Title Change in A/CS Domain Score
Hide Description

Change in the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) 12-item Additional Concerns Subscale (A/CS) domain score is a 12-item scale. 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 of the original trial through Week 12 of this extension trial
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anamorelin HCl Placebo
Hide 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 345 168
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
4.46  (0.92) 3.24  (1.01)
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.
 
Arm/Group Title Anamorelin HCl Placebo
Hide 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   --/--      --/--    
Hide Serious Adverse Events
Anamorelin HCl Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/343 (12.83%)      21/167 (12.57%)    
Blood and lymphatic system disorders     
Anaemia  1  3/343 (0.87%)  3 1/167 (0.60%)  1
Febrile neutropenia  1  1/343 (0.29%)  1 1/167 (0.60%)  1
Thrombocytopenia  1  1/343 (0.29%)  1 2/167 (1.20%)  2
Cardiac disorders     
Angina unstable  1  1/343 (0.29%)  1 0/167 (0.00%)  0
Cardiopulmonary failure  1  0/343 (0.00%)  0 1/167 (0.60%)  1
Pericardial effusion  1  0/343 (0.00%)  0 1/167 (0.60%)  1
Congenital, familial and genetic disorders     
Tracheo-oesophageal fistula  1  1/343 (0.29%)  1 0/167 (0.00%)  0
Gastrointestinal disorders     
Duodenal ulcer  1  1/343 (0.29%)  1 0/167 (0.00%)  0
Gastric haemorrhage  1  1/343 (0.29%)  1 1/167 (0.60%)  1
Oesophagitis  1  1/343 (0.29%)  1 0/167 (0.00%)  0
Vomiting  1  1/343 (0.29%)  1 0/167 (0.00%)  0
General disorders     
Asthenia  1  1/343 (0.29%)  1 1/167 (0.60%)  2
Death  1  1/343 (0.29%)  1 3/167 (1.80%)  3
Oedema peripheral  1  1/343 (0.29%)  1 0/167 (0.00%)  0
Multi-organ failure  1  1/343 (0.29%)  1 0/167 (0.00%)  0
Sudden death  1  1/343 (0.29%)  1 0/167 (0.00%)  0
Infections and infestations     
Lower respiratory tract infection  1  1/343 (0.29%)  1 0/167 (0.00%)  0
Pneumonia  1  4/343 (1.17%)  4 0/167 (0.00%)  0
Injury, poisoning and procedural complications     
Splenic rupture  1  1/343 (0.29%)  1 0/167 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal pain  1  1/343 (0.29%)  1 0/167 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer metastatic  1  1/343 (0.29%)  1 0/167 (0.00%)  0
Neoplasm progression  1  16/343 (4.66%)  16 7/167 (4.19%)  7
Tumour haemorrhage  1  1/343 (0.29%)  1 0/167 (0.00%)  0
Nervous system disorders     
Cerebrovascular accident  1  1/343 (0.29%)  1 0/167 (0.00%)  0
Convulsion  1  1/343 (0.29%)  1 0/167 (0.00%)  0
Nervous system disorder  1  1/343 (0.29%)  1 0/167 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/343 (0.29%)  1 0/167 (0.00%)  0
Chronic obstructive pulmonary disease  1  1/343 (0.29%)  1 0/167 (0.00%)  0
Dyspnoea  1  2/343 (0.58%)  2 1/167 (0.60%)  1
Pleural effusion  1  0/343 (0.00%)  0 1/167 (0.60%)  1
Pulmonary embolism  1  1/343 (0.29%)  1 0/167 (0.00%)  0
Respiratory failure  1  2/343 (0.58%)  2 1/167 (0.60%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 14.0
Hide 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   94/343 (27.41%)      57/167 (34.13%)    
Blood and lymphatic system disorders     
Anaemia  1  45/343 (13.12%)  56 25/167 (14.97%)  37
Neutropenia  1  18/343 (5.25%)  21 8/167 (4.79%)  8
General disorders     
Asthenia  1  19/343 (5.54%)  20 14/167 (8.38%)  14
Metabolism and nutrition disorders     
Decreased appetite  1  12/343 (3.50%)  13 10/167 (5.99%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 14.0
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
Layout table for additonal information
Responsible Party: Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier: NCT01395914    
Other Study ID Numbers: HT-ANAM-303
First Submitted: June 30, 2011
First Posted: July 18, 2011
Results First Submitted: March 15, 2017
Results First Posted: July 11, 2017
Last Update Posted: September 14, 2017