Clinical trial · Interventional
Add-on Study for Protocol G200802 (NCT02463032): Effect of GTx-024 on Maximal Neuromuscular Function and Lean Body Mass
NCT02746328CI-TRIAL-00074363withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigational drug development was halted.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ER+ and AR+ Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GTx-024 9 or 18 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GTx-024 9 or 18 mg
- description
- Patients enrolled in G200802 receiving GTx-024 9 or 18 mg
- interventionNames
- Drug: GTx-024 9 or 18 mg
Primary outcomes (1)
- measure
- Maximal Power Production
- timeFrame
- 24 Weeks
- description
- Describe the effect of 24 weeks of treatment of GTx-024 on maximal power production as assessed by inertial-load cycle ergometry
Secondary outcomes (6)
- measure
- Maximal Power Production
- timeFrame
- 12 Weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. In screening for, and ultimately randomized into, protocol G200802 2. Give voluntary, written and signed, informed consent for this add-on study 3. Age 18 to 70 years old 4. Physically capable of mounting and riding a stationary bicycle 5. Subject agrees to not significantly alter physical activity or current physical training during the study period Exclusion Criteria: 1. Subject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the Investigator 2. Subjects unwilling to or unable to comply with the protocol 3. Any other condition which per investigators' judgement may increase subject risk
References
Publications (0)
Data not yet available
No reference posted for this study.