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NCT03914742 · ClinicalTrials.gov registry record · Phase 1

BGB-290 and Temozolomide in Treating Patients With Recurrent Gliomas With IDH1/2 Mutations

A Phase 1 study of Recurrent Glioblastoma and Recurrent WHO Grade III Glioma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Completed
Registry status
Phase 1
Development phase
67
Enrollment target
12
Study locations

NCT03914742: Completed Phase 1 study of Recurrent Glioblastoma and Recurrent WHO Grade III Glioma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

NCT03914742 is a Phase 1 study of Recurrent Glioblastoma and Recurrent WHO Grade III Glioma that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 67 participants, roughly in line with the 68-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target. The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03914742, a Phase 1 study of Recurrent Glioblastoma and Recurrent WHO Grade III Glioma, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

COMPLETED
Registry status
Phase 1
Development phase
67 participants
Enrollment target
12
Study locations

Study Summary

This phase I/II trial studies the side effects and how well BGB-290 and temozolomide work in treating patients with gliomas (brain tumors) with IDH1/2 mutations that have come back. BGB-290 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving BGB-290 and temozolomide may work better in treating patients with recurrent gliomas.

Primary Outcome

DLTS defined as the combination regimen that yields a dose limiting toxicity (DLT) rate less than, or equal to 33%. A DLT is defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and meets any of the criteria below. Any DLT must be a toxicity considered at least possibly related to pamiparib (BGB-290) or TMZ.

Conditions Studied

Recurrent Glioblastoma Recurrent WHO Grade III Glioma IDH1 Mutation Recurrent WHO Grade II Glioma IDH2 Mutation

Interventions

  • DRUG Temozolomide
  • PROCEDURE Therapeutic Conventional Surgery
  • DRUG PARP Inhibitor BGB-290

Study Locations (12)

Pennsylvania

  • University of Pennsylvania - Philadelphia
  • Hillman Cancer Center at University of Pittsburgh Cancer Institute - Pittsburgh

Alabama

  • UAB Comprehensive Cancer Center - Birmingham

California

  • University of California, Los Angeles - Los Angeles

Connecticut

  • Yale University - New Haven

Maryland

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore

Massachusetts

  • Dana Farber Cancer Institute - Boston

Michigan

  • Josephine Ford Cancer Center at Henry Ford Hospital - Detroit

Missouri

  • Washington University - St Louis

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 2020-02-16
Est. Completion 2023-10-31
Phase Phase 1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

523 total trials

What the finished NCT03914742 record still lists

NCT03914742 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, roughly in line with the 68-participant average among 62 other Recurrent Glioblastoma trials with a reported enrollment target.

The record links to 5 conditions, with Recurrent Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which Temozolomide is the first listed.

NCT03914742 lists 12 locations in 11 states (Pennsylvania, Alabama, California).

Frequently Asked Questions

What is clinical trial NCT03914742 about?

NCT03914742 is a clinical study titled "BGB-290 and Temozolomide in Treating Patients With Recurrent Gliomas With IDH1/2 Mutations". This phase I/II trial studies the side effects and how well BGB-290 and temozolomide work in treating patients with gliomas (brain tumors) with IDH1/2 mutations that have come back. BGB-290 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemo...

What is the current status of trial NCT03914742?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2020-02-16. Estimated completion is 2023-10-31.

What conditions does trial NCT03914742 study?

This clinical trial studies the following conditions: Recurrent Glioblastoma, Recurrent WHO Grade III Glioma, IDH1 Mutation, Recurrent WHO Grade II Glioma, IDH2 Mutation.

What interventions are being tested in trial NCT03914742?

The interventions under investigation include: Temozolomide (DRUG), Therapeutic Conventional Surgery (PROCEDURE), PARP Inhibitor BGB-290 (DRUG).

Who is sponsoring clinical trial NCT03914742?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03914742 being conducted?

This trial has 12 study locations across Alabama, California, Connecticut, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Recurrent Glioblastoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03914742's enrollment target sits among peer trials

67 17th of 62 higher than 46 of 62 other Recurrent Glioblastoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Recurrent Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03914742, the US trial registry maintained by the National Library of Medicine. NCT03914742 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.