Recurrent Glioblastoma Multiforme (GBM) Clinical Trial
Official title:
A Phase 1b Dose Escalation/Dose Expansion Study of Icapamespib (PU-AD) in Patients With Recurrent Malignant Glioma
This is a 2-part multicenter Phase 1b study designed to test icapamespib in patients with recurrent brain lesions. Part 1 of the trial will be a standard 3 by 3 dose escalation design where different doses are examined. Part 2 will be a dose expansion cohort to further evaluate the recommended Phase 2 dose (RP2D). The RP2D is defined as the dose level recommended for further clinical study, or the highest dose tested.
This is a 2-part multicenter Phase 1b study designed to test the safety, tolerability and pharmacokinetics of single agent oral icapamespib in patients with recurrent brain lesions. Part 1 of the trial will be a standard 3 by 3 dose escalation design where different doses are examined. Part 2 will be a dose expansion cohort to further evaluate the recommended Phase 2 dose (RP2D). The RP2D is defined as the dose level recommended for further clinical study, or the highest dose tested. The RP2D may be the same as the maximum tolerated dose (MTD) or modified from the MTD based on assessment of overall exposure, safety experience in Cycle 2 and beyond, and clinical benefit data in the study. The RP2D will be determined in the dose expansion phase of the study. Part 1: Up to 30 patients with 1st, 2nd or 3rd recurrence of IDH wild type glioblastoma multiforme (GBM) or grade 3 or 4, Isocitrate dehydrogenase (IDH) mutant astrocytoma will be enrolled to evaluate the safety, pharmacokinetics (PK), pharmacodynamics, and MTD of single agent oral icapamespib administered daily. Icapamespib will be administered orally once daily for each 28-day cycle. The initial dose in this trial will be 20 mg in Cohort 1. Dose escalation will proceed as follows: - 100% increment until the first drug-related Grade 2 adverse event (AE) occurs, then - 50% increment until the first drug-related Grade 3 event occurs, then - 33% increment until the first Dose Limiting Toxicities (DLT) occurs, then - 20% increment until RP2D is declared. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00290771 -
Efficacy and Safety of Imatinib Mesylate Plus Hydroxyurea (HU) in Patients With Recurrent Glioblastoma Multiforme (GBM)
|
Phase 2 |