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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01395914
First Posted: July 18, 2011
Last Update Posted: September 14, 2017
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.
Information provided by (Responsible Party):
Helsinn Therapeutics (U.S.), Inc
Results First Submitted: March 15, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

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

Participant Flow:   Overall Study
    Anamorelin HCl   Placebo
STARTED   345   168 
ITT Population   345   168 
Safety Population   343   167 
COMPLETED   273   131 
NOT COMPLETED   72   37 
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 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent-to-treat (ITT) Population included all randomized patients.

Reporting Groups
  Description
Anamorelin HCl Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.
Placebo 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 Total of all reporting groups

Baseline Measures
   Anamorelin HCl   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 345   168   513 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      83  24.1%      43  25.6%      126  24.6% 
Male      262  75.9%      125  74.4%      387  75.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: 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 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Treatment-emergent Adverse Events   [ Time Frame: Over the 12-week treatment period ]

2.  Secondary:   Change in Body Weight   [ Time Frame: Change in body weight from baseline of the original trial through Week 12 of this extension trial. ]

3.  Secondary:   Change in Handgrip Strength of the Non-Dominant Hand   [ Time Frame: Change in HGS from baseline of the original trial through Week 12 of this extension trial. ]

4.  Secondary:   Change in A/CS Domain Score   [ Time Frame: Change in FAACT A/CS Domain Score from baseline of the original trial through Week 12 of this extension trial ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Richard K. Bourne, Ph.D.
Organization: Helsinn Therapeutics (US), Inc.
phone: 732-603-2852
e-mail: richard.bourne@helsinn.com



Responsible Party: Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier: NCT01395914     History of Changes
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