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

Part of paid clinical trials in Waltham, Massachusetts.

Sponsor
BPGbio
Study ID
NCT07674095
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Mar 1, 2021
Status verified
Apr 2026
Primary completion
Jul 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Glioblastoma Cohort
    Cohort 1 will consist of adults (at least 18 years old) newly diagnosed with glioblastoma, not yet treated with radiation, chemotherapy, immunotherapy or targeted therapy in the 14 days after resection, in the Truveta database between 01-01-2021 and 06-30-2025.
  • Arm: Glioblastoma BPM31510 trial-eligible Cohort
    Cohort 2 will consist of a subset of Cohort 1 who meet the eligibility criteria specified in of the Phase 2 BPM31510 trial for which this group potentially will serve as an external comparator arm.

Primary Outcome Measure

Number of Truveta participants with glioblastoma [ Time Frame: 01 Jan 2021 to 30 Jun 2025 ]

Locations (1)

FacilityCityStateZIPSite coordinators
BPGbioWalthamMassachusetts02451-

Find similar trials in Waltham, MA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
BPGbio· Waltham, MA

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