A Study To Determine How BI 907828 Is Taken Up In The Tumor And To Determine The Highest Dose Of BI 907828 That Could Be Tolerated In Combination With Radiation Therapy In People With A Brain Tumor Called Glioblastoma

Overview

About this study

The purpose of this study is to examine the pharmacological effects of the compound BI 907828 on patient tumors at an early stage of drug development.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - Main Phase 0:

  • Histologically (if prior biopsy) or radiologically diagnosed glioblastoma.
  • Eligible for neurosurgical tumor resection.
  • Patients must be at least 18 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Adequate organ function.
  • Life expectancy ≥ 3 months at the start of treatment in the opinion of the investigator.

Inclusion Criteria - Main Phase Ia:

  • Histologically demonstrated diagnosis of TP53 wild type glioblastoma harboring unmethylated MGMT promoters (Glioblastoma definition according to 2021 WHO Classification of CNS tumors; i.e., IDH-wild type only).
  • Patient has undergone neurosurgical tumor resection and is eligible for standard radiotherapy.
  • Formalin-fixed paraffin-embedded tumor blocks or representative H/E (haematoxylin/eosin) slides (preferably both) must be available for retrospective histopathological central review.
  • Locally performed histopathological diagnosis will be accepted for entry into this trial.
  • Patients must be at least 18 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Adequate organ function.
  • Life expectancy ≥ 3 months at the start of treatment in the opinion of the investigator.

Exclusion Criteria - Main Phase 0:

  • Known TP53 mutant glioblastoma.
    • Note: testing is not mandatory for inclusion.
  • Known IDH mutant grade IV astrocytoma.
    • Note: testing is not mandatory for inclusion.
  • Patients with pacemakers or other metallic implants that can interfere with the magnetic field during MRI investigations.
  • Inability to undergo contrast-enhanced MRI (GFR < 30 mL/min).

Exclusion Criteria - Main Phase Ia:

  • Patients who have received previous systemic therapy (with the exception of patients who participated in Phase 0) or radiotherapy for glioblastoma.
  • Patients with pacemakers or other metallic implants that can interfere with the magnetic field during MRI investigations.
  • Inability to undergo contrast-enhanced MRI (GFR < 30 mL/min).

Eligibility last updated 3/1/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Wendy Sherman, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Jann Sarkaria, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Maciej Mrugala, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions