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.
This is a multi-center, open-label, single-arm, rollover study designed to provide participants with newly diagnosed glioblastoma who have completed Study NBM-BMX-003 (the parent study) with continued access to study treatment. Eligible participants will transition into this study to continue receiving study drugs (NBM-BMX and temozolomide) at the same doses and schedules as in the parent study. For participants enrolled in the dose-escalation cohorts of the parent study who received lower doses of NBM-BMX, escalation to a higher dose demonstrated to be safe in the parent study may be permitted with Sponsor approval. Participants may continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or up to 12 cycles of treatment, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Each capsule contains 100 mg of the active ingredient.
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.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
NOT_YET_RECRUITINGTaichung Veterans General Hospital
Taichung, Taiwan
NOT_YET_RECRUITINGLinkou Chang-Gung Memorial Hospital
Taoyuan City, Taiwan
RECRUITINGFrequency, types, severity, and relationship to NBM-BMX of adverse events (AEs)
To evaluate the long-term safety and tolerability of NBM-BMX in combination with temozolomide.
Time frame: Through study completion, an average of 1 year.
Progression-free survival (PFS) and overall survival (OS)
To assess the preliminary long-term efficacy of the combination therapy.
Time frame: Through study completion, an average of 1 year.
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