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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination therapy in glioblastoma | Experimental | Subjects with newly diagnosed glioblastoma who have completed Study NBM-BMX-003 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBM-BMX Capsule | Drug | Each capsule contains 100 mg of the active ingredient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion 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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chia-Chung Hou, Ph.D. | Contact | 886 2 26559109 | 101 | alison.hou@novelwisepharma.com |
| Cherry Hsu | Contact | 886 2 27891060 | 509 | cherry.hsu@effpha.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Not yet recruiting | Kaohsiung City | 807 | Taiwan |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Temozolomide | Drug | 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. |
|
|
| Taichung Veterans General Hospital | Not yet recruiting | Taichung | 407 | Taiwan |
|
| Linkou Chang-Gung Memorial Hospital | Recruiting | Taoyuan City | 333 | Taiwan |
|
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |