Multi-kinase Inhibitor TG02 (TG02) in Elderly Newly Diagnosed or Adult Relapsed Patients With Ana… (NCT03224104) | Clinical Trial Compass
CompletedPhase 1
Multi-kinase Inhibitor TG02 (TG02) in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma.
Austria, France, Germany71 participantsStarted 2018-06-12
Plain-language summary
This is a three parallel cohort, open-labeled, non-randomized, multicenter study. All three cohorts will enroll independently.
Who can participate
Age range18 Years
SexALL
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Specifics for groups A and B
* Newly diagnosed glioblastoma or anaplastic astrocytoma, IDH1R132H-non-mutant by immunohistochemistry locally assessed, with formalin-fixed, paraffin-embedded (FFPE) tissue available for central MGMT testing and optional biomarker studies (treatment allocation will be performed based on centrally assessed MGMT result)
* Tumor debulking surgery, including partial resection
* Age \> 65 and considered non-eligible for combination therapy (TMZ/RT→TMZ) in Investigator's opinion
* No prior RT with overlap of radiation fields with the planned RT in this study (Group A)
* No prior therapy for glioblastoma or anaplastic astrocytoma before surgery
* Brain MRI within 14 days before the first dose of TG02
Specifics for group C
* IDH1R132H-non-mutant glioblastoma or anaplastic astrocytoma at first relapse with tissue available from first surgery. \[Per 2016 World Health Organization (WHO) classification, in patients older than 55 years of age at diagnosis with a histological diagnosis of glioblastoma, without a pre-existing lower grade glioma and with non-midline tumor location, immunohistochemical negativity for IDH1R132H suffices for classification as glioblastoma. In all other instances of diffuse gliomas, lack of IDH1R132H immunopositivity should be followed by IDH1 and isocitrate dehydrogenase 2 (IDH2) sequencing to detect or exclude other less common IDH mutations.\]
* Brain MRI at the time of progression or 14 days before the first dose of TG02 and …
What they're measuring
1
Maximum Tolerated Dose (MTD)
Timeframe: From the initiation of TG02 treatment until the determination of the Maximum Tolerated Dose (MTD) for each participant, which is expected to occur within the first 28-day cycle for most participants.
2
Percentage of Participants Maintaining Progression-free Survival at 6 Months (PFS-6)
Timeframe: The time frame for assessing PFS spans from the date of consent to either disease progression or death. Data are specifically presented for the 6-month time point.
Trial details
NCT IDNCT03224104
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC