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

NCT03914742 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-01-14

Study results available
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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.

Conditions

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

Interventions

DRUG

PARP Inhibitor BGB-290

Given PO

DRUG

Temozolomide

Given PO

PROCEDURE

Therapeutic Conventional Surgery

resection surgery

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • BeiGene

    collaborator INDUSTRY

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Ranjit Bindra, MD · ABTC/Yale University

  • David Schiff, MD · ABTC/University of Virginia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-16
Primary Completion
2023-10-31
Completion
2023-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03914742 on ClinicalTrials.gov