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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: Completed Phase 3 study, sponsored by European Organisation for Research and Treatment of Cancer - EORTC.
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, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Overall Survival (OS): OS is defined as the number of days from date of randomization to the date of death due to any cause. If a patient has not died, the data will be censored at the last date documented to be alive.
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 |
What the finished NCT03345095 record still lists
NCT03345095 is an interventional study that assigns participants to a tested intervention. The registered 749 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Temozolomide is the first listed.
NCT03345095 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03345095's enrollment target sits among peer trials
749 472nd of 2000 higher than 1,529 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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