At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Study of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma: A Phase Ib Study
In Brief
A Phase 1 clinical trial evaluating TG02, Radiation Therapy, and 1 other intervention for Astrocytoma, Grade III and Glioblastoma. Completed, enrolled 71 participants across 10 sites in 5 countries.
Detailed Summary
This is a three parallel cohort, open-labeled, non-randomized, multicenter study. All three cohorts will enroll independently.
Study Details
Timeline
Interventions
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.
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
For group B TMZ will be given in the standard 28-day cycle regimen (150-200 mg/m2) for 5 days.