Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)
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|ClinicalTrials.gov Identifier: NCT01395914|
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : July 11, 2017
Last Update Posted : September 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cachexia Non-Small Cell Lung Cancer||Drug: Anamorelin HCl Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||513 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||February 2015|
Experimental: 100 mg QD
100 mg yellow coated, oval tablet; oral administration once daily
Drug: Anamorelin HCl
Placebo Comparator: Placebo
Placebo tablets identical in appearance to active tablets; oral administration once daily
- Percentage of Participants With Treatment-emergent Adverse Events [ Time Frame: Over the 12-week treatment period ]To Evaluate the Safety and Tolerability of Anamorelin HCl.
- Change in Body Weight [ Time Frame: Change in body weight from baseline of the original trial through Week 12 of this extension trial. ]
- 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. ]
- 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 ]
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395914