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NCT04762069 · ClinicalTrials.gov registry record · Phase 2
A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme
A Phase 2 study of Glioblastoma Multiforme, Adult, sponsored by CNS Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 210
- Enrollment target
- 20
- Study locations
NCT04762069: Active Phase 2 study of Glioblastoma Multiforme, Adult, sponsored by CNS Pharmaceuticals.
NCT04762069 is a Phase 2 study of Glioblastoma Multiforme, Adult that is active but no longer recruiting, run by CNS Pharmaceuticals. The registered enrollment target is 210 participants, below the 394-participant average among 9 other Glioblastoma Multiforme, Adult trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04762069, a Phase 2 study of Glioblastoma Multiforme, Adult, is active but no longer recruiting, sponsored by CNS Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 210 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label, multicenter, randomized, parallel, 2-arm, efficacy and safety study. Patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive berubicin or lomustine for the evaluation of OS. Additional endpoints will include response and progression outcomes evaluated by a blinded central reviewer for each patient according to RANO criteria. A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.
Primary Outcome
To assess the effect of berubicin compared with lomustine on overall survival (OS) in adult patients with GBM that has recurred or progressed after standard initial therapy
Conditions Studied
Interventions
- DRUG Lomustine
- DRUG Berubicin
Study Locations (20)
California
- Southern California Permanente Medical Group - Los Angeles
- University of California Irvine - Orange
- University of Califonia San Diego Moores Cancer Center - San Diego
- University of California San Francisco - San Francisco
- Saint John's Cancer Institute at Providence Saint John's Health Center - Santa Monica
Florida
- Baptist MD Anderson Cancer Center - Jacksonville
- Mayo Clinic Florida - Jacksonville
- Baptist Miami - Miami
Massachusetts
- Tufts Medical Center - Boston
- UMass (ACC) - Hollings Cancer Center (HCC) - Worcester
New Jersey
- Hackensack Meridian Health - Hackensack
- Rutgers University - Piscataway
Arkansas
- University of Arkansas - Little Rock
Colorado
- HCA Healthcare Research Institute - Englewood
Georgia
- Piedmont Healthcare - Atlanta
Illinois
- Rush University Cancer Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2021-05-18 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 2 |
What the registry record for NCT04762069 still lists
NCT04762069 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 394-participant average among 9 other Glioblastoma Multiforme, Adult trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Glioblastoma Multiforme, Adult appearing as the primary indexed condition, and to 2 interventions - of which Lomustine is the first listed.
NCT04762069 names 20 study sites across 12 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04762069 about?
NCT04762069 is a clinical study titled "A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme". This is an open-label, multicenter, randomized, parallel, 2-arm, efficacy and safety study. Patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive berubicin or lomustine for the evaluation of OS. Additional endpoints will include response and prog...
What is the current status of trial NCT04762069?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 210 participants. The study started on 2021-05-18. Estimated completion is 2026-03-31.
What conditions does trial NCT04762069 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Adult.
What interventions are being tested in trial NCT04762069?
The interventions under investigation include: Lomustine (DRUG), Berubicin (DRUG).
Who is sponsoring clinical trial NCT04762069?
This trial is sponsored by CNS Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04762069 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04762069's enrollment target sits among peer trials
210 6th of 9 higher than 4 of 9 other Glioblastoma Multiforme, Adult trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma Multiforme, Adult 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.
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