A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma (MIRAGE)
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ClinicalTrials.gov Identifier: NCT03345095 |
Recruitment Status :
Active, not recruiting
First Posted : November 17, 2017
Last Update Posted : October 6, 2020
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Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators:
Celgene
Canadian Cancer Trials Group
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
Tracking Information | |||||
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First Submitted Date ICMJE | November 7, 2017 | ||||
First Posted Date ICMJE | November 17, 2017 | ||||
Last Update Posted Date | October 6, 2020 | ||||
Actual Study Start Date ICMJE | July 26, 2018 | ||||
Estimated Primary Completion Date | July 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Overall Survival (OS) [ Time Frame: From the date of randomization up to the date of death, assessed up to 49 months ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Newly Diagnosed Glioblastoma | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
749 | ||||
Original Estimated Enrollment ICMJE |
750 | ||||
Estimated Study Completion Date ICMJE | July 2023 | ||||
Estimated Primary Completion Date | July 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Austria, Belgium, Canada, Denmark, France, Germany, Netherlands, Norway, Spain, Switzerland, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03345095 | ||||
Other Study ID Numbers ICMJE | EORTC-BTG-1709 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | European Organisation for Research and Treatment of Cancer - EORTC | ||||
Study Sponsor ICMJE | European Organisation for Research and Treatment of Cancer - EORTC | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | European Organisation for Research and Treatment of Cancer - EORTC | ||||
Verification Date | October 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |