NG101m Adjuvant Therapy in Glioblastoma Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Glioblastoma Multiforme
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Radiation: Radiotherapy Drug: Temozolomide Drug: NG101mMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 (...
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.
Tracking Information
- NCT #
- NCT04373785
- Collaborators
- Not Provided
- Investigators
- Study Director: Yvonne Kew, MD, PhD NeuGATE Theranostics
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