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Study of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma — STEAM  

Glioblastoma Clinical Trial

Official title:
Study of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma: A Phase Ib Study

Clinical Trial Summary

This is a three parallel cohort, open-labeled, non-randomized, multicenter study. All three cohorts will enroll independently.

Clinical Trial Description

Group A will be composed of newly-diagnosed, elderly patients with IDH1R132H-non mutant and MGMT promoter-unmethylated anaplastic astrocytoma or glioblastoma who will receive TG02 and RT. Group B will be composed of newly-diagnosed, elderly patients with IDH1R132H-non mutant and MGMT promoter-methylated anaplastic astrocytoma or glioblastoma who will receive TG02 and temozolomide. For both Groups A and B, there will be a classical 3+3 dose escalation and an expansion phase in the study. Up to a total of 24 evaluable patients in Group A and up to a total of 12 evaluable patients in Group B (up to 36 evaluable patients for Groups A and B). Group C patients will be composed of patients initially diagnosed with IDH1R132H-non-mutant anaplastic astrocytoma or glioblastoma at first relapse post TMZ/RT-->TMZ therapy who will receive TG02. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03224104
Study type Interventional
Source European Organisation for Research and Treatment of Cancer - EORTC
Contact
Status Completed
Phase Phase 1
Start date June 12, 2018
Completion date May 5, 2022
View Details
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