Phase III Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC)
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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: NCT01355484 |
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Recruitment Status :
Completed
First Posted : May 18, 2011
Results First Posted : March 3, 2016
Last Update Posted : March 3, 2016
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| Study Type | Interventional |
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| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Conditions |
Muscle Wasting Non Small Cell Lung Cancer |
| Interventions |
Drug: GTx-024 Drug: placebo |
| Enrollment | 321 |
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | GTx-024 | Placebo |
|---|---|---|
 Arm/Group Description |
subject will receive GTx-024 treatment for the duration of the trial GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial. |
subject will receive placebo for the duration of the trial placebo: subject will receive placebo for the duration of the trial |
| Period Title: Overall Study | ||
| Started | 160 | 161 |
| Completed | 109 | 107 |
| Not Completed | 51 | 54 |
| Arm/Group Title | GTx-024 | Placebo | Total | |
|---|---|---|---|---|
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Arm/Group Description |
subject will receive GTx-024 treatment for the duration of the trial GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial. |
subject will receive placebo for the duration of the trial placebo: subject will receive placebo for the duration of the trial |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 160 | 161 | 321 | |
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Baseline Analysis Population Description |
Subjects included in the Full Analysis Set
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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| Number Analyzed | 160 participants | 161 participants | 321 participants | |
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60.5
(36 to 84)
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62.0
(34 to 88)
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61.0
(34 to 88)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 160 participants | 161 participants | 321 participants | |
| Female |
43 26.9%
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46 28.6%
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89 27.7%
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| Male |
117 73.1%
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115 71.4%
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232 72.3%
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Provide Sponsor with an advance copy of any proposed results communication at least 60 days prior to the date of the planned submission or presentation and Sponsor shall have 60 days from receipt to request any changes. Sponsor may request a delay of up to 60 additional days.
The PI shall not present data until the earlier of Sponsor's publication of the results of all investigators participating in the Study or 18 months after completion of the Study at all participating sites.
| Name/Title: | Senior Director, Clinical Operations |
| Organization: | GTx Inc. |
| Phone: | 1-901-261-3795 |
| EMail: | mdesordi@gtxinc.com |
| Responsible Party: | GTx |
| ClinicalTrials.gov Identifier: | NCT01355484 |
| Other Study ID Numbers: |
G300504 POWER1 ( Other Identifier: GTx ) |
| First Submitted: | May 12, 2011 |
| First Posted: | May 18, 2011 |
| Results First Submitted: | February 4, 2016 |
| Results First Posted: | March 3, 2016 |
| Last Update Posted: | March 3, 2016 |