A Rollover Study of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma

A vizsgálat adatai

Ki végzi

Novelwise Pharmaceutical Corporation

Azonosító

NCT07569042

A regiszteradat frissítve

2026. május 6.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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.

Bevonási feltételek: 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.

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

ClinicalTrials.gov NCT07569042