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ACTIVE NOT RECRUITING
NCT07674095

Assessment of the Truveta Database as Meeting FDA Fit-for-Purpose Requirements to Provide External Controls for Study BPM31510 in Participants With Glioblastoma

Sponsor: BPGbio

View on ClinicalTrials.gov

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.

Official title: A Retrospective Observational Cohort Study to Assess the Degree to Which the Truveta Dataset Meets FDA Fit-for-Purpose Requirements for Label-Enabling Regulatory Use for BPM31510 in Patients With Newly Diagnosed Glioblastoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2021-03-01

Completion Date

2026-09-01

Last Updated

2026-06-29

Healthy Volunteers

No

Conditions

Locations (1)

BPGbio

Waltham, Massachusetts, United States