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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 is a Phase 1 study that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 1 participants.
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.
Interventions
- DRUG Minocycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2015-11 |
| Est. Completion | 2018-05-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02201563
The ClinicalTrials.gov registry entry for NCT02201563 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Minocycline is the first listed.
NCT02201563 reports 0 study locations.
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.
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