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NCT07674095 · ClinicalTrials.gov registry record
Assessment of a Large US EHR Database as Meeting FDA Fit-for-Purpose Requirements to Provide External Controls for Study BPM31510 in Participants With Glioblastoma
A clinical trial, sponsored by BPGbio.
- Active
- Registry status
- 150
- Enrollment target
NCT07674095 is a clinical trial that is active but no longer recruiting, run by BPGbio. The registered enrollment target is 150 participants.
The verdict
NCT07674095 is active but no longer recruiting, sponsored by BPGbio.
- ACTIVE NOT RECRUITING
- Registry status
- 150 participants
- Enrollment target
Study Summary
Glioblastoma is a rare, aggressive brain tumor that leads to death within 2 years of diagnosis in more than half of patients. There are currently 123 studies ongoing that are testing treatments for glioblastoma. BPGbio has developed BPM31510 and is executing an ongoing single-arm Phase 2 study (NCT04752813) targeting 50 participants. Because glioblastoma is a rare and often fatal disease with multiple drugs in development, a randomized placebo-controlled trial is unlikely to be feasible. Therefore, BPGbio is exploring the possible use of untreated patients from the Truveta database to create a control group. The purpose of this study is to explore whether the Truveta database in this indication meets FDA criteria as fit-for-purpose for regulatory use.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2026-09-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07674095
The ClinicalTrials.gov registry entry for NCT07674095 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BPGbio, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT07674095 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07674095 about?
NCT07674095 is a clinical study titled "Assessment of a Large US EHR Database as Meeting FDA Fit-for-Purpose Requirements to Provide External Controls for Study BPM31510 in Participants With Glioblastoma". Glioblastoma is a rare, aggressive brain tumor that leads to death within 2 years of diagnosis in more than half of patients. There are currently 123 studies ongoing that are testing treatments for glioblastoma. BPGbio has developed BPM31510 and is executing an ongoing single-arm Phase 2 study (NCT0...
What is the current status of trial NCT07674095?
This trial is currently active not recruiting. The enrollment target is 150 participants. The study started on 2021-03-01. Estimated completion is 2026-09-01.
Who is sponsoring clinical trial NCT07674095?
This trial is sponsored by BPGbio, which has 10 total clinical trials registered on ClinicalTrials.gov.
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