Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 1 study, sponsored by Actelion.
NCT01499251 is a Phase 1 study that was terminated before completion, run by Actelion. The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
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 The study will end when all patients (excluding those prematurely withdrawn or lost to follow-up) in each part of the study have completed a visit at month 12 and 30 days of safety follow-up.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 |
Why NCT01499251 stopped before completion
NCT01499251 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 3 interventions - of which Phase 1 Dose Escalation is the first listed.
NCT01499251 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01499251's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01535430 · 75 participants
Assessment of Eloquent Function in Brain Tumor Patients
- NCT01542879 · 75 participants · Phase 1
Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer
- NCT02232191 · 75 participants · Phase 2
Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients
- NCT02754544 · 75 participants · NA
Electrocorticography in Mapping Functional Brain Areas During Surgery in Patients With Brain Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia