Continued NBM-BMX with temozolomide for newly diagnosed glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, open-label, single-arm rollover study that provides continued access to NBM-BMX plus temozolomide for participants who completed Arm B of the parent NBM-BMX-003 study. Eligible participants will continue the same doses and schedules used in the parent study, with possible dose escalation for those from dose-escalation cohorts if approved by the Sponsor. Treatment may continue until disease progression, unacceptable toxicity, withdrawal of consent, death, or up to 12 cycles, whichever occurs first. The trial focuses on collecting long-term safety and efficacy data while maintaining continuity of therapy for participants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants must meet all of the following criteria to be eligible for the study:

1. 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.
2. Histologically confirmed glioblastoma.
3. Can enroll into this rollover study within 35 days after completing the last dose of NBM-BMX in the parent study.
4. Have signed and dated the informed consent form.
5. Karnofsky performance status (KPS) ≥ 60 at enrollment in this study.
6. Adequate organ functions as defined by the following criteria:

   1. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN)
   2. Total serum bilirubin ≤ 1.5 × ULN unless bilirubin elevation is related to Gilbert's Syndrome for which bilirubin ≤ 3 × ULN
   3. Absolute neutrophil count (ANC) ≥ 1,000/µL
   4. Platelets ≥ 75,000/µL
   5. Hemoglobin ≥ 8.0 g/dL
   6. Non-indexed estimated glomerular filtration rate (eGFR) ≥ 50 mL/min
7. Women of childbearing potential must have a negative pregnancy test performed within 14 days before the first dose of this study.
8. 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.
9. 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:

1. Currently receive or plan to receive anti-cancer treatments other than the study drugs including Gliadel wafer implant or tumor treating fields (TTFields).
2. Permanently discontinued from the parent study due to unacceptable toxicity, non-compliance with study procedures, withdrawal of consent, or any other reason.
3. 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.
4. QTcF \> 480 msec
5. Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
6. Have known hypersensitivity reaction to temozolomide, dacarbazine or NBM-BMX.
7. Have difficulty swallowing (including those require nasogastric tube) or with impaired absorption of oral medications.
8. Female who are pregnant or breastfeeding.
9. 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.

Where it's running

• Linkou Chang-Gung Memorial Hospital
  Taoyuan City, Taiwan Recruiting
• Kaohsiung Medical University Chung-Ho Memorial Hospital
  Kaohsiung City, Taiwan Not yet recruiting
• Taichung Veterans General Hospital
  Taichung, Taiwan Not yet recruiting

Study contacts

• Study coordinator: Chia-Chung Hou, Ph.D.
• Email: alison.hou@novelwisepharma.com
• Phone: 886 2 26559109

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.