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NCT01499251 · ClinicalTrials.gov registry record · Phase 1
Clinical Study on the Safety and Tolerability of Macitentan in Combination With Dose-dense Temozolomide in Patients With Recurrent Glioblastoma
A Phase 1 study, sponsored by Actelion.
- Terminated
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT01499251 is a Phase 1 study that was terminated before completion, run by Actelion. The registered enrollment target is 75 participants.
The verdict
NCT01499251, a Phase 1 study, was terminated before completion, sponsored by Actelion.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
This is an open-label, single arm, Phase 1 study to assess the safety and tolerability of macitentan in combination with dose-dense temozolomide in adult patients with recurrent glioblastoma or gliosarcoma. The study is composed of three parts. A Phase 1 Dose Escalation Period with a traditional 3+3 design will determine the maximum tolerated dose of macitentan in combination with dose-dense temozolomide. A Phase 1b Period will expand the safety and tolerability data of two doses of macitentan and dose-dense temozolomide selected from the Dose Escalation Period and explore efficacy. An Ancillary Study will further evaluate the effects of macitentan on biomarkers in brain tumor tissue. The study is planned to have a minimum duration of 12 months. The study will end when all patients (excluding those prematurely withdrawn or lost to follow-up) in each part of the study have completed a visit at month 12 and 30 days of safety follow-up.
Interventions
- DRUG Phase 1 Dose Escalation
- DRUG Phase 1b
- DRUG Ancillary Study
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2012-01 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01499251
The ClinicalTrials.gov registry entry for NCT01499251 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 75 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 3 interventions - of which Phase 1 Dose Escalation is the first listed.
NCT01499251 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01499251 about?
NCT01499251 is a clinical study titled "Clinical Study on the Safety and Tolerability of Macitentan in Combination With Dose-dense Temozolomide in Patients With Recurrent Glioblastoma". This is an open-label, single arm, Phase 1 study to assess the safety and tolerability of macitentan in combination with dose-dense temozolomide in adult patients with recurrent glioblastoma or gliosarcoma. The study is composed of three parts. A Phase 1 Dose Escalation Period with a traditional 3+3...
What is the current status of trial NCT01499251?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2012-01. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01499251?
The interventions under investigation include: Phase 1 Dose Escalation (DRUG), Phase 1b (DRUG), Ancillary Study (DRUG).
Who is sponsoring clinical trial NCT01499251?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
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