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NCT02201563 · ClinicalTrials.gov registry record · Phase 1
Minocycline Therapy for Management of Adverse Radiation Effects
A Phase 1 study, sponsored by University of Pittsburgh.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT02201563: Clinical Trial Phase 1 study, sponsored by University of Pittsburgh.
NCT02201563 is a Phase 1 study that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02201563, a Phase 1 study, was terminated before completion, sponsored by University of Pittsburgh.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Stereotactic radiosurgery (SRS) is a well-established treatment for patients with metastatic brain tumors. Although SRS has a very high tumor growth control these interventions are associated with adverse radiation effects (ARE) in approximately 15 % of patients. The traditional approach, and still a mainstay, is the administration of a course of high dose anti-inflammatory corticosteroids. Currently there are no other effective oral neuroprotective agents in clinical practice which can improve outcomes of patients with ARE after radiosurgery for brain metastases. Minocycline, an antibiotic with a favorable adverse effect profile and pharmacokinetics, has been shown to have neuroprotective properties in experimental models of a variety of neurological diseases, as well as in human clinical trials. The investigators propose a single arm clinical trial, to evaluate the safety and feasibility of minocycline in improving ARE. This study will recruit 15 patients who will be treated with minocycline (100mg BID) for 3 months. This clinical trial has the potential to prove that minocycline therapy is safe in this patient population. In addition, positive results will provide preliminary evidence for its use in an array of radiosurgical indications.
Primary Outcome
Safety will be assessed by monitoring blood levels of drug, liver enzymes, renal function tests, and monitoring for major and minor side-effects.
Interventions
- DRUG Minocycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2015-11 |
| Est. Completion | 2018-05-31 |
| Phase | Phase 1 |
Why NCT02201563 stopped before completion
NCT02201563 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Minocycline is the first listed.
NCT02201563 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02201563 about?
NCT02201563 is a clinical study titled "Minocycline Therapy for Management of Adverse Radiation Effects". Stereotactic radiosurgery (SRS) is a well-established treatment for patients with metastatic brain tumors. Although SRS has a very high tumor growth control these interventions are associated with adverse radiation effects (ARE) in approximately 15 % of patients. The traditional approach, and still ...
What is the current status of trial NCT02201563?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2015-11. Estimated completion is 2018-05-31.
What interventions are being tested in trial NCT02201563?
The interventions under investigation include: Minocycline (DRUG).
Who is sponsoring clinical trial NCT02201563?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02201563's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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