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Clinical Study on Macitentan, RT and TMZ Concurrent Therapy Followed by Maintenance Macitentan and TMZ in Newly Diagnosed Glioblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02254954
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Actelion
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Terminated
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Macitentan in combination with RT & TMZ

Escalating doses of macitentan in combination with RT and TMZ, and maintenance TMZ.

Interventions

Drug: - Macitentan in combination with RT and TMZ

Escalating doses of macitentan in combination with RT and TMZ, and maintenance TMZ.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

MD Anderson Cancer Center, Houston, Texas

Status

Address

MD Anderson Cancer Center

Houston, Texas, 77030

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