CE8

CE8 Details
Status: Closed
Activation Date: 2018MAY24
Closing Date: 2020SEP17
Phase: III

Description: A Phase III Trial of Marizomib in Combination with Standard Temozolomide-Based Radiochemotherapy versus Standard Temozolomide-Based Radiochemotherapy Alone in Patients with Newly-Diagnosed Glioblastoma

Eligibility: WHO grade IV glioblastoma - Tumor resection or biopsy only - Availability of FFPR tumour block or slide for mandatory MGMT analysis - eligible for standard TMZ/RT ->TMZ - KPS>=70 - Recovered from effects of surgery - 18 years of age when ICF signed - stable or decreasing dose of steroids for 1 week prior - life expectancy of 3 months - Adequate organ function as per lab values - negative serum pregnancy test 7 days prior to first dose - no IDH1 mutation - no prior treatment for GBM other than surgery - planned treatment with TTF

Objective: To compare the overall survival of glioblastoma patients treated with standard TMZ-based radiochemotherapy alone or TMZ-based radiochemotherapy in combination with marizomib. Additionally, PFS survival will be compared in the two treatment arms. Additionally the safety and tolerability of TMZ-based radiochemotherapy in combination with marizomib will be assessed. The neurocognitive function and OoL of the MRZ arm will also be assessed.

Participation: Limited to invited centres; Site Selection Open

Lay Description: The standard of care for newly diagnosed glioblastoma includes surgery, involved-field radiotherapy, and concomitant and six cycles of maintenance temozolomide chemotherapy, however the prognosis remains dismal. Marizomib has been tested in patients with newly diagnosed and recurrent glioblastoma in phase I and phase II studies. In patients with recurrent glioblastoma, marizomib was administered as a single agent or in combination with bevacizumab (NCT02330562). Based on encouraging observations, a phase I/II trial of marizomib in combination with TMZ/RT -->TMZ in newly diagnosed glioblastoma has been launched (NCT02903069) which explores safety and tolerability of this triple combination and which shall help to determine the dose for further clinical trials in glioblastoma. In this context, given that marizomib has been established as a safe addition to the standard TMZ/RT -->TMZ, a phase III study is considered essential to establishing its impact on overall survival.

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Disease Site	Trial Code	Patients Accrued	Patients - Blocks	Patients - Slides	Patients - Blocks and/or Slides
BRAIN	CE8	301	0	0	0

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(Core size is 0.6 mm)

Disease Site	Trial Code	Patients Accrued	TMA Blocks	Patients on TMA Blocks
BRAIN	CE8	301	0	0

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Disease Site	Trial Code	Patients Accrued	Patients - Whole Blood	Patients - Cellular Component of Blood	Patients - DNA extracted from Blood	Patients - RNA extracted from Blood	Patients - Plasma	Patients - Serum	Patients - Urine	Patients - Buccal
BRAIN	CE8	301	0	0	0	0	3	4	0	0