CLINICAL TRIAL SUMMARY

MDACC Study No:2011-0746 (clinicaltrials.gov NCT No: NCT01499251)
Title:A Phase I/Ib, open-label study in patients with recurrent glioblastoma to assess the safety and tolerability of macitentan in combination with dose-dense temozolomide.
Principal Investigator:Charles A. Conrad
Treatment Agent:Macitentan; Temozolomide
Study Status:Open
Study Description:The goal of this clinical research study is to find the highest tolerable dose
of macitentan combined with temozolomide that can be given to patients with
glioblastoma or gliosarcoma. Researchers also want to learn how quickly the
study drug spreads through the body once it has been given. The safety of these
drugs given together will also be studied.

Macitentan is designed to block several proteins on the surface of the cells
that are important to the growth and division of cancer cells and the growth of
blood vessels, which may cause the cancer cells to die.

Temozolomide is designed to damage the DNA of cancer cells. The damaged DNA
may cause tumor cell death.

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Disease Group:Brain; CNS
Phase of Study:Phase I
Treatment Agents:Macitentan
Temozolomide
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:
Supported By:ACTELION Pharmaceuticals Ltd
Return Visit:
Home Care:


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Physician Name:Charles A. Conrad
Dept:Neuro Oncology
For Clinical Trial Enrollment:713-792-2883
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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