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A Rollover Study of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma

NCT07569042 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • Malignant Neoplasm of Brain

Interventions

DRUG

NBM-BMX Capsule

Each capsule contains 100 mg of the active ingredient.

DRUG

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.

Sponsors & Collaborators

  • Novelwise Pharmaceutical Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2029-09-30
Completion
2030-12-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07569042 on ClinicalTrials.gov