In the phase I component, the primary objective is to determine the toxicity of meclofenamate (MFA) therapy in addition to standard temozolomide (TMZ) in patients with the first relapse of MGMT promotor methylated glioblastoma. Efficacy, safety, tolerability and impact on quality of life are the secondary objectives. In phase II, the main objective is to determine the efficacy of MFA in addition to TMZ therapy. The primary endpoint in phase I is the incidence of dose-limiting toxicities (DLTs) during the first 8 weeks of MFA treatment. In phase II, the primary endpoint is progression-free survival (PFS) determined according to RANO criteria in cranial MRI.
In the phase I component, the primary objective is to determine the toxicity of meclofenamate (MFA) therapy in addition to standard temozolomide (TMZ) in patients with the first relapse of MGMT promotor methylated glioblastoma. Efficacy, safety, tolerability and impact on quality of life are the secondary objectives. In phase II, the main objective is to determine the efficacy of MFA in addition to TMZ therapy. The primary endpoint in phase I is the incidence of dose-limiting toxicities (DLTs) during the first 8 weeks of MFA treatment. In phase II, the primary endpoint is progression-free survival (PFS) determined according to RANO criteria in cranial MRI.
