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Investigational drug development was halted.
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This is a multiple site, proof of concept feasibility study to describe the effect of GTx-024 9 or 18 mg on physical function in female subjects, from protocol G200802, with ER+/AR+ breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GTx-024 9 or 18 mg | Experimental | Patients enrolled in G200802 receiving GTx-024 9 or 18 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GTx-024 9 or 18 mg | Drug | Patients enrolled in G200802 receiving GTx-024 9 or 18 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Power Production | Describe the effect of 24 weeks of treatment of GTx-024 on maximal power production as assessed by inertial-load cycle ergometry | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Power Production | Describe the effect of 12 weeks of treatment of GTx-024 on maximal power production as assessed by inertial-load cycle ergometry | 12 Weeks |
| Lean Body Mass | Describe the effect of 24 weeks of treatment of GTx-024 on lean body mass (LBM) as assessed by CT images of the lumbar region from L3 to the iliac crest |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Objective | Describe the impact of baseline measures and measures obtained throughout the study on maximal power production and its change from baseline | 24 Weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hannah M Linden, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington, School of Medicine | Seattle | Washington | 98109 | United States |
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| ID | Term |
|---|---|
| C547106 | ostarine |
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| 24 Weeks |
| Lean Body Mass | Describe the effect of 12 weeks of treatment of GTx-024 on LBM as assessed by CT images of the lumbar region from L3 to the iliac crest | 12 Weeks |
| Maximal Power Production, Scaled to Total Body Mass | Describe the effect of 24 weeks of treatment of GTx-024 on maximal power production scaled (Watts/kilogram) to total body mass (TBM), as assessed by inertial-load cycle ergometry | 24 Weeks |
| Maximal Power Production, Scaled to Lean Body Mass | Describe the effect of 24 weeks of treatment of GTx-024 on maximal power production scaled (Watts/kilogram) to LBM, as assessed by inertial-load cycle ergometry | 24 Weeks |
| Optimal Pedaling Rate | Describe the effect of 24 weeks of treatment of GTx-024 on optimal pedaling rate | 24 Weeks |