Clinical trial · Interventional
Clinical Study on Macitentan, RT and TMZ Concurrent Therapy Followed by Maintenance Macitentan and TMZ in Newly Diagnosed Glioblastoma
A Single-center, Open-label, Phase 1 Study of Macitentan, Radiotherapy and Temozolomide Concurrent Therapy Followed by Maintenance Therapy With Macitentan and Temozolomide in Subjects With Newly Diagnosed Glioblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision due to low recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Macitentan in combination with RT and TMZ | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Macitentan in combination with RT & TMZ
- description
- Escalating doses of macitentan in combination with RT and TMZ, and maintenance TMZ.
- interventionNames
- Drug: Macitentan in combination with RT and TMZ
Primary outcomes (1)
- measure
- Number of subjects with dose-limiting toxicities observed during the first 10 weeks of study treatment (i.e., 6 weeks of concurrent therapy with macitentan, RT and TMZ and 4 weeks of monotherapy with macitentan).
- timeFrame
- Start of treatment to week 10
Secondary outcomes (10)
- measure
- Plasma concentrations of endothelin-1
- timeFrame
- Baseline, Weeks 2, 6, and 10
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects at least 18 years of age * Histologically proven supratentorial GBM or gliosarcoma * Use of effective contraception by women of childbearing potental. * Use of effective contraception by fertile males with a female partner of childbearing potential. * Interval of at least 3 weeks after biopsy or open surgery and able to begin study treatment. * Result from a post-operative contrast-enhanced brain MRI within 72 hours after surgery or biopsy. * Adequate bone marrow function * Karnofsky Performance Score of at least 70. Exclusion Criteria: * Prior treatment for glioblastoma or gliosarcoma. * Evidence of leptomeningeal spread of glibolastoma or gliosarcoma. * Tumor foci below the tentorium or beyond the cranial vault. * Evidence of recent hemorrhage on post-operative contrast enhanced brain MRI (except hemosiderin, resolving hemorrhage changes related to surgery, presence of punctuate hemorrhage in tumor). * Aspartate aminotransferase or alanine aminotransferase \> 3 times the upper limit of normal. * Supine systolic blood pressure \< 100 mmHg or diastolic blood pressure \< 50 mmHg. * Medical history of orthostatic hypotension. * International normalized ratio \> 1.5 on anticoagulant therapy, active bleeding on low molecular weight heparin, or chronic condition with a high risk of bleeding. * Severe renal impairment. * Severe hepatic impairment. * Severe, active co-morbidity: (e.g. cardiac disease; respiratory disease; chronic hepatitis; hemtological and bone marrow diseases; severe malabsoprtion; human immunodeficiency virus). * No concurrent strong CYP3A4 inducers or inhibitors. * No investigational drug within 4 weeks of starting study treatment. * Any life-threatening condition that could affect protocol compliance.
References
Publications (0)
Data not yet available