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

PHASE1CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

June 12, 2018

Primary Completion Date

May 5, 2022

Study Completion Date

May 5, 2022

Conditions
Astrocytoma, Grade IIIGlioblastoma
Interventions
DRUG

TG02

"The initial cohorts of Groups A and B will receive TG02 at 200 mg on intermittent schedules in combination with either RT or TMZ. TG02 will be escalated to 250 mg if the dose decision criteria are met in the first cohort.~The initial cohort in Group C will receive TG02 alone at 250 mg on intermittent schedules. It will be continued at this dose if feasible or decreased to 200 or 150 mg if not tolerated."

RADIATION

Radiation Therapy

For group A standard involved-field hypofractionated RT will be administered at 39.9 Gy in 15 fractions of 2.66 Gy for 3 weeks

DRUG

Temozolomide

For group B TMZ will be given in the standard 28-day cycle regimen (150-200 mg/m2) for 5 days.

Trial Locations (10)

1090

Universitaetskliniken der Uni Wien - Universitaetsklinikum Wien - AKH uniklinieken, Vienna

3015

Erasmus MC Cancer Institute - location Daniel den Hoed, Rotterdam

8091

UniversitaetsSpital Zurich, Zurich

13385

Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone, Marseille

53205

Universitaetsklinikum Bonn, Bonn

60528

Klinikum Der J.W. Goethe Universitaet-Klinik und Poliklinik fur Neurochirurgie, Frankfurt

69120

Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital, Heidelberg

69677

CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer, Bron

93053

Universitaetskliniken Regensburg - Universitaetsklinikum Regensburg, Regensburg

Unknown

CHRU de Lille, Lille

All Listed Sponsors
collaborator

Tragara Pharmaceuticals, Inc.

INDUSTRY

lead

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

NCT03224104 - Study of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma | Biotech Hunter | Biotech Hunter