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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: Clinical Trial Phase 1 study, sponsored by Actelion.
NCT02254954 is a Phase 1 study that was terminated before completion, run by Actelion. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT02254954 stopped before completion
NCT02254954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Macitentan in combination with RT and TMZ is the first listed.
NCT02254954 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02254954's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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