Actively Recruiting
A Rollover Study of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma
Led by Novelwise Pharmaceutical Corporation · Updated on 2026-05-06
15
Participants Needed
3
Research Sites
245 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Rollover Study of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completed or currently enrolled in Arm B of Study NBM-BMX-003 and may benefit from continued treatment
- Histologically confirmed glioblastoma diagnosis
- Can enroll within 35 days after last dose of NBM-BMX in parent study
- Signed and dated informed consent form
- Karnofsky performance status of 60 or higher at enrollment
- Adequate organ function including liver enzymes, bilirubin, neutrophils, platelets, hemoglobin, and kidney function
- Negative pregnancy test within 14 days before first dose for women of childbearing potential
- Agreement to use accepted contraceptive methods during study and for 6 months after final temozolomide dose
- Willingness and ability to follow study visits, treatments, lab tests, and procedures
You will not qualify if you...
- Currently receiving or planning other anti-cancer treatments besides study drugs (including Gliadel wafer or tumor treating fields)
- Permanently stopped parent study due to unacceptable toxicity, non-compliance, withdrawal, or other reasons
- Positive test for hepatitis B or C unless viral levels are undetectable
- QTcF interval longer than 480 milliseconds
- Currently taking strong CYP2C8 inhibitors or inducers
- Known allergy to temozolomide, dacarbazine, or NBM-BMX
- Difficulty swallowing or absorbing oral medications
- Pregnant or breastfeeding females
- Severe acute or chronic medical or psychiatric conditions or abnormal labs posing risk according to Investigator or sponsor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Not Yet Recruiting
2
Taichung Veterans General Hospital
Taichung, Taiwan, 407
Not Yet Recruiting
3
Linkou Chang-Gung Memorial Hospital
Taoyuan City, Taiwan, 333
Actively Recruiting
Research Team
C
Chia-Chung Hou, Ph.D.
CONTACT
C
Cherry Hsu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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