Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active study, sponsored by BPGbio.
NCT07674095 is a clinical trial that is active but no longer recruiting, run by BPGbio. The registered enrollment target is 150 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The number of Truveta participants eligible for each cohort will be determined: * Cohort 1: The number of adults in Truveta with newly diagnosed glioblastoma between 01 Jan 2021 and 30 Jun 2025 based on the below criteria: * International Classification of Diseases, Tenth Revision, clinical modification (ICD 10-CM) and/or Systematized Nomenclature of Medicine - Clinical Terms (SNOMED CT) code for malignant brain neoplasm and/or malignant glioma of brain * Resection/biopsy with histology su
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2026-09-01 |
What the registry record for NCT07674095 still lists
NCT07674095 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT07674095 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00412594 · 150 participants · Phase 2
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
- NCT01484730 · 150 participants
A Pilot Study to Evaluate Multi-Spectral and Laser Speckle Imaging and Multiphoton Microscopy During Vascular Occlusion
- NCT01985919 · 150 participants
Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples
- NCT02016248 · 150 participants · NA
SBRT Boost for Unfavorable Prostate Cancer'
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI