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NCT01616758 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of GTx024 in Women With Metastatic Breast Cancer
A Phase 2 study, sponsored by GTx.
- Terminated
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT01616758: Clinical Trial Phase 2 study, sponsored by GTx.
NCT01616758 is a Phase 2 study that was terminated before completion, run by GTx. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01616758, a Phase 2 study, was terminated before completion, sponsored by GTx.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
The primary efficacy analysis will be the clinical benefit at 6 months as measured by a modified Response Evaluation Criteria in Solid Tumors RECIST classification. Key secondary endpoints of objective response rate, progression free survival, time to progression, duration of response, effects on physical function, and effects on tumor progression in women with Androgen Receptor positive breast cancer will also be assessed.
Primary Outcome
N=17 of 22 subjects with AR Positive Breast Cancer - Clinical Benefit is defined as a complete response (CR), partial response (PR), or stable disease (SD).
Interventions
- DRUG GTx-024 9mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2013-04 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
Why NCT01616758 stopped before completion
NCT01616758 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which GTx-024 9mg is the first listed.
NCT01616758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01616758 about?
NCT01616758 is a clinical study titled "Phase II Study of GTx024 in Women With Metastatic Breast Cancer". The primary efficacy analysis will be the clinical benefit at 6 months as measured by a modified Response Evaluation Criteria in Solid Tumors RECIST classification. Key secondary endpoints of objective response rate, progression free survival, time to progression, duration of response, effects on ph...
What is the current status of trial NCT01616758?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2013-04. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01616758?
The interventions under investigation include: GTx-024 9mg (DRUG).
Who is sponsoring clinical trial NCT01616758?
This trial is sponsored by GTx, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01616758's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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