A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme (NCT04762069)
A Multicenter, Open-Label Study With a Randomized Control Arm of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme After Failure of Standard First Line Therapy
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Arkansas — Little Rock, Arkansas
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (48 Sites)
Showing the first 25 of 48 sites.
- University of Arkansas — Little Rock, Arkansas
- Southern California Permanente Medical Group — Los Angeles, California
- University of California Irvine — Orange, California
- University of Califonia San Diego Moores Cancer Center — San Diego, California
- University of California San Francisco — San Francisco, California
- Saint John's Cancer Institute at Providence Saint John's Health Center — Santa Monica, California
- HCA Healthcare Research Institute — Englewood, Colorado
- Baptist MD Anderson Cancer Center — Jacksonville, Florida
- Mayo Clinic Florida — Jacksonville, Florida
- Baptist Miami — Miami, Florida
- Piedmont Healthcare — Atlanta, Georgia
- Rush University Cancer Center — Chicago, Illinois
- University of Kentucky — Lexington, Kentucky
- Tulane Cancer Center Clinic — New Orleans, Louisiana
- Tufts Medical Center — Boston, Massachusetts
- UMass (ACC) - Hollings Cancer Center (HCC) — Worcester, Massachusetts
- Mayo Clinic — Rochester, Minnesota
- University of Nebraska Medical Center — Omaha, Nebraska
- Hackensack Meridian Health — Hackensack, New Jersey
- Rutgers University — Piscataway, New Jersey
- Atlantic Healthcare — Summit, New Jersey
- Roswell Park Cancer Center — Buffalo, New York
- Duke University School of Medicine — Durham, North Carolina
- Ohio State University — Columbus, Ohio
- Providence Health — Portland, Oregon
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.