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)
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.
∙ 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.