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NCT02254954 · ClinicalTrials.gov registry record · Phase 1
Clinical Study on Macitentan, RT and TMZ Concurrent Therapy Followed by Maintenance Macitentan and TMZ in Newly Diagnosed Glioblastoma
A Phase 1 study, sponsored by Actelion.
- Terminated
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT02254954 is a Phase 1 study that was terminated before completion, run by Actelion. The registered enrollment target is 30 participants.
The verdict
NCT02254954, a Phase 1 study, was terminated before completion, sponsored by Actelion.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a prospective, single-center, open-label, 3+3 dose escalation Phase 1 safety study. Adults with newly diagnosed GBM or gliosarcoma will receive macitentan in addition to the standard of care treatment for GBM. The study consists of a screening period, a treatment period, and a 30-day safety follow up period. The treatment period includes 6 weeks of concurrent therapy (macitentan+RT+TMZ), 4 weeks of monotherapy (macitentan) and 12 cycles of maintenance therapy (macitentan+TMZ). The study will end when the last treated subject has completed study treatment and the 30-day safety follow-up period. The planned duration of the study is approximately 34-38 months depending on the number of dose levels and cohorts of subjects enrolled. Subject participation in the study will be for approximately 16 months.
Interventions
- DRUG Macitentan in combination with RT and TMZ
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-01-08 |
| Est. Completion | 2016-09-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02254954
The ClinicalTrials.gov registry entry for NCT02254954 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actelion, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Macitentan in combination with RT and TMZ is the first listed.
NCT02254954 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02254954 about?
NCT02254954 is a clinical study titled "Clinical Study on Macitentan, RT and TMZ Concurrent Therapy Followed by Maintenance Macitentan and TMZ in Newly Diagnosed Glioblastoma". This is a prospective, single-center, open-label, 3+3 dose escalation Phase 1 safety study. Adults with newly diagnosed GBM or gliosarcoma will receive macitentan in addition to the standard of care treatment for GBM. The study consists of a screening period, a treatment period, and a 30-day safety ...
What is the current status of trial NCT02254954?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2015-01-08. Estimated completion is 2016-09-29.
What interventions are being tested in trial NCT02254954?
The interventions under investigation include: Macitentan in combination with RT and TMZ (DRUG).
Who is sponsoring clinical trial NCT02254954?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
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