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Ibrutinib With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma

NCT03535350 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-09-30

No results posted yet for this study

Summary

Safety of combination of ibrutinib and radiation at various dose levels in unmethylated o6-methylguanine-DNA-methyltransferase (MGMT) glioblastoma and study of ibrutinib, temozolomide, and radiation combination therapy in methylated MGMT glioblastoma.

Conditions

Interventions

DRUG

Ibrutinib

Dose response of Ibrutinib. Level 1 starting dose is 420mg daily. Level 2 starting dose is 560mg daily. Level -1 starting dose is 280mg daily. November 2020: 420 mg of ibrutinib plus temozolomide and radiation was found to be safe - up to 36 participants can betreated at the expansion cohort in both arm 1 and arm 2.

RADIATION

Radiation

2Gy x 30minutes for 6 weeks.

DRUG

Temozolomide (TMZ)

Cycle 1 150mg/m2 and cycle 2-6 will be up to 200mg/m2.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • David Peereboom, MD · Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-24
Primary Completion
2023-04-04
Completion
2025-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03535350 on ClinicalTrials.gov