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Clinical Trial Summary

The purpose of this clinical trial is to evaluate the addition of NG101m adjuvant therapy to standard of care treatment of glioblastoma multiforme. All subjects will receive NG101m capsules along with the standard treatment of temozolomide and radiation.


Clinical Trial Description

Glioblastoma multiforme (GBM) is the most lethal form of malignant brain cancer, with about 12,000 new cases diagnosed each in the the United States. The current standard treatment consists of maximal, safe resection, followed by radiation therapy of 60 Gray (Gy) with concomitant oral temozolomide (TMZ) for 6 weeks, then continue with six cycles of high-dose temozolomide. The median survival rate for newly diagnosed GBM patients is 14.6 months with a 2-year overall survival (OS) rate of 27.2%. This clinical trial evaluates the 2-year OS of oral NG101m as an adjuvant therapy to chemoradiotherapy in newly diagnosed GBM subjects. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04373785
Study type Interventional
Source NeuGATE Theranostics
Contact Thien Tran, PharmD
Phone 713-534-1300
Email TTran@NeuGATE.org
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date January 1, 2024
Completion date December 31, 2027

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