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NCT02330562 · ClinicalTrials.gov registry record · Phase 1
Stage 1: Marizomib + Bevacizumab in WHO Gr IV GBM; Stage 2: Marizomib Alone; Stage 3: Combination of Marizomib and Bevacizumab
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 121
- Enrollment target
NCT02330562: Completed Phase 1 study, sponsored by Celgene.
NCT02330562 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 121 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (102% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02330562, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 121 participants
- Enrollment target
Study Summary
This is a Phase 1/2 clinical trial to evaluate a new combination of drugs, marizomib (MRZ) and bevacizumab (BEV; Avastin®), for the treatment of WHO Grade IV malignant glioma. The study population includes subjects who are in first or second relapse and who have not previously received any bevacizumab or other anti-angiogenic agent or proteasome inhibitor for treatment of malignant glioma. Part 1 Phase 1 evaluates the combination of MRZ and BEV, while Part 2 Phase 2 evaluates single-agent MRZ. Part 3 (Phase 2) includes a combination MRZ using intra-patient dose escalation, and BEV at a fixed dose. Part 4 Phase 1 evaluates MRZ through enteral administration, and BEV at a fixed dose. Part 5 Phase 1 evaluates the repeat-dose pharmacokinetics of MRZ administered IV with ECG.
Primary Outcome
Radiographic ORR is defined as the percentage of participants achieving a Complete Response (CR) or Partial Response (PR), as assessed by the investigator, according to RANO 2010 criteria. Tumor response assessment was conducted every 2 cycles of study therapy. 95% confidence interval from exact binomial distribution (Clopper-Pearson method).
Interventions
- DRUG MRZ
- DRUG BEV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2015-04-15 |
| Est. Completion | 2021-06-02 |
| Phase | Phase 1 |
What the finished NCT02330562 record still lists
NCT02330562 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (102% higher).
The record links to 0 conditions, and to 2 interventions - of which MRZ is the first listed.
NCT02330562 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02330562 about?
NCT02330562 is a clinical study titled "Stage 1: Marizomib + Bevacizumab in WHO Gr IV GBM; Stage 2: Marizomib Alone; Stage 3: Combination of Marizomib and Bevacizumab". This is a Phase 1/2 clinical trial to evaluate a new combination of drugs, marizomib (MRZ) and bevacizumab (BEV; Avastin®), for the treatment of WHO Grade IV malignant glioma. The study population includes subjects who are in first or second relapse and who have not previously received any bevacizum...
What is the current status of trial NCT02330562?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 121 participants. The study started on 2015-04-15. Estimated completion is 2021-06-02.
What interventions are being tested in trial NCT02330562?
The interventions under investigation include: MRZ (DRUG), BEV (DRUG).
Who is sponsoring clinical trial NCT02330562?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02330562's enrollment target sits among peer trials
121 476th of 2000 higher than 1,522 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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