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A Rollover Study of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma
Sponsor: Novelwise Pharmaceutical Corporation
Summary
This clinical trial is a rollover study designed to provide continued access to NBM-BMX and temozolomide (TMZ) for eligible participants with newly diagnosed glioblastoma who have completed the designated treatment in Study NBM-BMX-003 (the parent study), and to evaluate the long-term safety and efficacy of NBM-BMX administered in combination with TMZ.
Official title: A Rollover Study to Evaluate the Long-Term Safety and Efficacy of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma Who Completed Study NBM-BMX-003 (the Parent Study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2026-04-20
Completion Date
2030-12-31
Last Updated
2026-05-06
Healthy Volunteers
No
Conditions
Interventions
NBM-BMX Capsule
Each capsule contains 100 mg of the active ingredient.
Temozolomide
Temodal will be administered orally at a 75 mg/m2 dose daily during concomitant therapy. In the maintenance period, days 1-5 of each cycle will be administered 150-200 mg/m2.
Locations (3)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Linkou Chang-Gung Memorial Hospital
Taoyuan City, Taiwan