Trial · NCT01499251
Clinical Study on the Safety and Tolerability of Macitentan in Combination With Dose-dense Temozolomide in Patients With Recurrent Glioblastoma
NCT01499251, Phase 1, Terminated, Actelion
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Study on the Safety and Tolerability of Macitentan in Combination With Dose-dense Temozolomide in Patients With Recurrent Glioblastoma. Trials, record NCT01499251. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01499251
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study on the Safety and Tolerability of Macitentan in Combination With Dose-dense Temozolomide in Patients With Recurrent Glioblastoma
- NCT number
- NCT01499251
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 75 participants, estimated
- Lead sponsor
- Actelion
- Conditions
- Glioblastoma
- Interventions
- Phase 1 Dose Escalation, Phase 1b, Ancillary Study
- First posted
- 2011-12-26
- Last updated
- 2016-05-05
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To determine the maximum tolerated dose of macitentan in combination with dose-dense temozolomide | Phase I Dose Escalation period (Dose-Limiting Toxicity from Baseline to 28 days for each dose level) | |
| Secondary | Number of patients with treatment-emergent adverse events (AEs) and serious AEs | Participants will be followed up for the duration of combination treatment, an expected average of 9-12 months. | for all study periods |
| Secondary | Number of patients with AEs leading to premature discontinuation of study treatment | Participants will be followed up for the duration of combination treatment, an expected average of 9-12 months. | for all study periods |
| Secondary | Incidence of treatment-emergent* marked laboratory abnormalities | Participants will be followed up for the duration of combination treatment, an expected average of 9-12 months. | for all study periods |
| Secondary | Number of patients with treatment-emergent ECG abnormalities | Up to 30 days after discontinuation of macitentan | for all study periods |
| Secondary | Change from baseline in vital signs | Up to 30 days after discontinuation of macitentan | for all study periods: systolic and diastolic blood pressure \[supine and standing\], average of the two measurements and pulse rate. |
| Secondary | Occurrence of at least grade 2 ALT and/or AST elevation | Participants will be followed up for the duration of combination treatment, an expected average of 9-12 months. | for all study periods |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34693288 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01499251
GET https://conductscience.org/api/trials/v1/NCT01499251/registered