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NCT03345095 · ClinicalTrials.gov registry record · Phase 3
A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma
A Phase 3 study, sponsored by European Organisation for Research and Treatment of Cancer - EORTC.
- Completed
- Registry status
- Phase 3
- Development phase
- 749
- Enrollment target
NCT03345095 is a Phase 3 study that has completed, run by European Organisation for Research and Treatment of Cancer - EORTC. The registered enrollment target is 749 participants.
The verdict
NCT03345095, a Phase 3 study, has completed, sponsored by European Organisation for Research and Treatment of Cancer - EORTC.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 749 participants
- Enrollment target
Study 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 Temozolomide+Radiotherapy(TMZ/RT) followed by Temozolomide (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.
Interventions
- DRUG Temozolomide
- RADIATION radiotherapy
- DRUG Marizomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 749 participants |
| Start Date | 2018-07-26 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03345095
The ClinicalTrials.gov registry entry for NCT03345095 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 749 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is European Organisation for Research and Treatment of Cancer - EORTC, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Temozolomide is the first listed.
NCT03345095 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03345095 about?
NCT03345095 is a clinical study titled "A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma". 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...
What is the current status of trial NCT03345095?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 749 participants. The study started on 2018-07-26. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT03345095?
The interventions under investigation include: Temozolomide (DRUG), radiotherapy (RADIATION), Marizomib (DRUG).
Who is sponsoring clinical trial NCT03345095?
This trial is sponsored by European Organisation for Research and Treatment of Cancer - EORTC, which has 15 total clinical trials registered on ClinicalTrials.gov.
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