Clinical Trials List
Protocol NumberNBM-BMX-005
NCT Number(ClinicalTrials.gov Identfier)NCT07569042
Active
2026-01-01 - 2030-12-31
Phase I/II
Recruiting3
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)
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Trial Applicant
Efficient Pharma Management Corp.
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Sponsor
Novelwise Pharmaceuticals CORP.
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Trial scale
Taiwan Multiple Center
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Update
2026/09/11
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Kuo-Chen Wei
Co-Principal Investigator
- 李丞騏 Division of Orthopedics
- 林亞銳 Division of Orthopedics
- 徐鵬瑋 Division of Orthopedics
- Chi-Cheng Chuang Division of Orthopedics
- Pin-Yuan Chen Division of Orthopedics
- 陳奎安 Division of Radiology
- 陳科廷 Division of Orthopedics
- 黃盈誠 Division of Orthopedics
- 蔡宏杰 Division of Orthopedics
- 盧郁仁 Division of Orthopedics
- 蕭庭毅 Division of Radiology
- 賴盈傑 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Malignant Neoplasm of Brain
Objectives
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.
Test Drug
NBM-BMX膠囊
Active Ingredient
NBM-BMX
Dosage Form
Capsule
Dosage
100mg
Endpoints
Frequency, 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. 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. 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. Through study completion, an average of 1 year.
Inclution Criteria
Participants must meet all of the following criteria to be eligible for the study:
Have completed or currently enrolled in Arm B of Study NBM-BMX-003 (the parent study), and in the opinion of the Investigator, may derive clinical benefit from continued treatment with study drugs.
Histologically confirmed glioblastoma.
Can enroll into this rollover study within 35 days after completing the last dose of NBM-BMX in the parent study.
Have signed and dated the informed consent form.
Karnofsky performance status (KPS) ≥ 60 at enrollment in this study.
Adequate organ functions as defined by the following criteria:
Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN)
Total serum bilirubin ≤ 1.5 × ULN unless bilirubin elevation is related to Gilbert's Syndrome for which bilirubin ≤ 3 × ULN
Absolute neutrophil count (ANC) ≥ 1,000/µL
Platelets ≥ 75,000/µL
Hemoglobin ≥ 8.0 g/dL
Non-indexed estimated glomerular filtration rate (eGFR) ≥ 50 mL/min
Women of childbearing potential must have a negative pregnancy test performed within 14 days before the first dose of this study.
Men and women of childbearing potential must agree to use acceptable contraceptive methods throughout the study period and for at least 6 months after the final dose of temozolomide.
Acceptable contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.
Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
Have completed or currently enrolled in Arm B of Study NBM-BMX-003 (the parent study), and in the opinion of the Investigator, may derive clinical benefit from continued treatment with study drugs.
Histologically confirmed glioblastoma.
Can enroll into this rollover study within 35 days after completing the last dose of NBM-BMX in the parent study.
Have signed and dated the informed consent form.
Karnofsky performance status (KPS) ≥ 60 at enrollment in this study.
Adequate organ functions as defined by the following criteria:
Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN)
Total serum bilirubin ≤ 1.5 × ULN unless bilirubin elevation is related to Gilbert's Syndrome for which bilirubin ≤ 3 × ULN
Absolute neutrophil count (ANC) ≥ 1,000/µL
Platelets ≥ 75,000/µL
Hemoglobin ≥ 8.0 g/dL
Non-indexed estimated glomerular filtration rate (eGFR) ≥ 50 mL/min
Women of childbearing potential must have a negative pregnancy test performed within 14 days before the first dose of this study.
Men and women of childbearing potential must agree to use acceptable contraceptive methods throughout the study period and for at least 6 months after the final dose of temozolomide.
Acceptable contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.
Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
Exclusion Criteria
Participants with any of the following will be excluded from the study:
Currently receive or plan to receive anti-cancer treatments other than the study drugs including Gliadel wafer implant or tumor treating fields (TTFields).
Permanently discontinued from the parent study due to unacceptable toxicity, non-compliance with study procedures, withdrawal of consent, or any other reason.
A positive test for hepatitis B (HBsAg) and/or hepatitis C (anti-HCV antibody), unless the HBV DNA level and/or HCV RNA level is below the limit of detection.
QTcF > 480 msec
Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
Have known hypersensitivity reaction to temozolomide, dacarbazine or NBM-BMX.
Have difficulty swallowing (including those require nasogastric tube) or with impaired absorption of oral medications.
Female who are pregnant or breastfeeding.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgement of the Investigator and/or sponsor, excess risks associated with study participation or study drug administration.
Currently receive or plan to receive anti-cancer treatments other than the study drugs including Gliadel wafer implant or tumor treating fields (TTFields).
Permanently discontinued from the parent study due to unacceptable toxicity, non-compliance with study procedures, withdrawal of consent, or any other reason.
A positive test for hepatitis B (HBsAg) and/or hepatitis C (anti-HCV antibody), unless the HBV DNA level and/or HCV RNA level is below the limit of detection.
QTcF > 480 msec
Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
Have known hypersensitivity reaction to temozolomide, dacarbazine or NBM-BMX.
Have difficulty swallowing (including those require nasogastric tube) or with impaired absorption of oral medications.
Female who are pregnant or breastfeeding.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgement of the Investigator and/or sponsor, excess risks associated with study participation or study drug administration.
The Estimated Number of Participants
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Taiwan
10 participants
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Global
10 participants
