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Enzastaurin (LY317615) Before and Concomitant with Radiation Therapy, Followed by Enzastaurin Maintenance Therapy in Patients with Newly Diagnosed Glioblastoma without Methylation of the Promoter Gene...

Update Il y a 5 ans
Reference: EUCTR2007-000281-21

Enzastaurin (LY317615) Before and Concomitant with Radiation Therapy, Followed by Enzastaurin Maintenance Therapy in Patients with Newly Diagnosed Glioblastoma without Methylation of the Promoter Gene of MGMT Enzyme – a Multicenter, Open-label, Uncontrolled Phase II Study

Woman and Man

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Extract

The study’s primary objective is evaluation of PFS-6 after diagnosis in patients with newly diagnosed glioblastoma without methylation of the promoter gene of MGMT enzyme treated with enzastaurin before and concomitantly to radiation therapy, followed by enzastaurin maintenance therapy. In a safety run- in phase, 2 dose regimen of enzastaurin will be explored: 500 mg given in one daily dose (QD) and two daily doses of 250 mg (BID) to proof the safety of the QD and BID regimen plus radiotherapy.

Inclusion criteria

  • primary glioma without methylation of the promoter gene of MGMT enzyme

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