AZD1390 for Glioblastoma

Overseen by Nader Sanai, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Nader Sanai

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, AZD1390, combined with radiation therapy in patients with severe brain cancer. AZD1390 is designed to enhance the effectiveness of radiation in killing cancer cells.

Research Team

Nader Sanai, MD

Principal Investigator

Chief Scientific Officer/Director

Eligibility Criteria

This trial is for adults over 18 with newly diagnosed or recurrent WHO Grade 4 glioma (a type of brain tumor) who are planning to have radiation. They must have measurable disease, stable seizures if present, and good organ function. Pregnant women, those with certain heart conditions or severe infections, and individuals on specific medications are excluded.

Inclusion Criteria

My blood tests show my organs and bone marrow are working well.

I can take pills by mouth.

For females of reproductive potential: use of highly effective contraception and agreement to use such a method during study participation

Exclusion Criteria

I have risk factors for abnormal heart rhythms.

Known allergic reactions to components of the AZD1390

I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.

Treatment Details

Interventions

• AZD1390 (ATM Kinase Inhibitor)

Trial Overview The study tests AZD1390 in combination with standard radiotherapy. It includes a Phase 0 part where patients' PK response is assessed and a Phase 1b expansion for responders. The goal is to see how well AZD1390 works alongside usual cancer treatments.

Participant Groups

Group I: Arm C: Newly-diagnosed Grade 4 Glioma Experimental Treatment 1 Intervention

Group II: Arm B: Recurrent Grade 4 Glioma Dose Escalation Experimental Treatment 1 Intervention

Group III: Arm A: Recurrent Grade 4 Glioma Surgical Cohort Time Escalation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Nader Sanai

Lead Sponsor

Trials

11

Recruited

440+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Ivy Brain Tumor Center

Collaborator

Trials

12

Recruited

910+

Barrow Neurological Institute

Collaborator

Trials

27

Recruited

7,100+