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New treatment option for Malignant Neoplasm of Brain
Official title A Rollover Study of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma
ClinicalTrials.gov ID: NCT07569042
What this study is testing
What is NBM-BMX Capsule?
NBM-BMX Capsule is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for malignant neoplasm of brain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- Permanently discontinued from the parent study due to unacceptable toxicity, non-compliance with study procedures, withdrawal of consent, or any...
- 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...
- QTcF \> 480 msec
- Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
See the full eligibility 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...
- Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Kaohsiung City, Taiwan
- Taichung, Taiwan
- Taoyuan City, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kaohsiung City, Taiwan; Taichung, Taiwan; Taoyuan City, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.