Clinical Study on Macitentan, RT and TMZ Concurrent Therapy Followed by Maintenance Macitentan and TMZ in Newly Diagnosed Glioblastoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/10/2016 |
| Start Date: | October 2014 |
| End Date: | November 2016 |
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
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.
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.
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.
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