Spots Global Cancer Trial Database for Study of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma
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Trial Identification
Brief Title: Study of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma
Official Title: Study of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma: A Phase Ib Study
Study ID: NCT03224104
Study Description
Brief Summary: This is a three parallel cohort, open-labeled, non-randomized, multicenter study. All three cohorts will enroll independently.
Detailed 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Universitaetskliniken der Uni Wien - Universitaetsklinikum Wien - AKH uniklinieken, Vienna, , Austria
CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer, Bron, , France
CHRU de Lille, Lille, , France
Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone, Marseille, , France
Universitaetsklinikum Bonn, Bonn, , Germany
Klinikum Der J.W. Goethe Universitaet-Klinik und Poliklinik fur Neurochirurgie, Frankfurt, , Germany
Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital, Heidelberg, , Germany
Universitaetskliniken Regensburg - Universitaetsklinikum Regensburg, Regensburg, , Germany
Erasmus MC Cancer Institute - location Daniel den Hoed, Rotterdam, , Netherlands
UniversitaetsSpital Zurich, Zürich, , Switzerland
Contact Details
Name: Emilie Le Rhun
Affiliation: CHRU de Lille
Role: PRINCIPAL_INVESTIGATOR
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