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ATM Kinase Inhibitor

AZD1390 for Glioblastoma

Phase < 1
Recruiting
Led By Nader Sanai, MD
Research Sponsored by Nader Sanai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Personal history of syncope of cardiovascular etiology, ventricular arrhythmia, or sudden cardiac arrest
Past medical history of interstitial lung disease, drug-induced ILD, or radiation pneumonitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month progression-free survival (pfs6) rate measured from the time of surgery to date of recurrence.
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of AZD1390 may include reactions related to the immune system, liver issues reflected by blood tests, possible impact on bone marrow leading to blood disorders, digestive disturbances like changes in pancreatic enzymes levels, and general symptoms such as fatigue.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.
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I have had lung conditions caused by drugs, disease, or radiation.
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My heart's electrical activity is normal and I don't have a long QT interval.
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I do not have any serious health conditions that would stop me from joining the study.
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I have a history of muscle disorders or high levels of muscle enzymes.
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I have previously been treated with ATM kinase inhibitors.
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I do not have any severe infections, liver disease, or active infections.
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I have a history of epilepsy or seizures not caused by a tumor.
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I am currently using a blood thinner that can't be stopped before surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month progression-free survival (pfs6) rate measured from the time of surgery to date of recurrence.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month progression-free survival (pfs6) rate measured from the time of surgery to date of recurrence. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 0: The relative pharmacokinetics (PK) of AZD1390 in tumor tissue from Grade 4 glioma participants treated with AZD1390
Phase 1b: Examine the rate of 6-month progression-free survival glioma participants with demonstrated PK effect.
Secondary study objectives
Adverse events
Deaths
Drug-related toxicity
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C: Newly-diagnosed Grade 4 GliomaExperimental Treatment1 Intervention
Group II: Arm B: Recurrent Grade 4 Glioma Dose EscalationExperimental Treatment1 Intervention
Group III: Arm A: Recurrent Grade 4 Glioma Surgical Cohort Time EscalationExperimental Treatment1 Intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Glioblastoma include radiotherapy and chemotherapy. Radiotherapy damages the DNA of cancer cells, leading to cell death, but its effectiveness is often limited by the cancer cells' ability to repair this damage. Agents like AZD1390, an ATM kinase inhibitor, enhance the effects of radiotherapy by preventing DNA repair in cancer cells. This mechanism is significant for Glioblastoma patients as it can potentially improve the efficacy of standard treatments, leading to better clinical outcomes and prolonged survival.

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,388 Previous Clinical Trials
289,109,868 Total Patients Enrolled
14 Trials studying Glioblastoma
1,026 Patients Enrolled for Glioblastoma
Nader SanaiLead Sponsor
8 Previous Clinical Trials
291 Total Patients Enrolled
6 Trials studying Glioblastoma
189 Patients Enrolled for Glioblastoma
Ivy Brain Tumor CenterOTHER
11 Previous Clinical Trials
802 Total Patients Enrolled
8 Trials studying Glioblastoma
666 Patients Enrolled for Glioblastoma

Media Library

AZD1390 (ATM Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05182905 — Phase < 1
Glioblastoma Research Study Groups: Arm A: Recurrent Grade 4 Glioma Surgical Cohort Time Escalation, Arm B: Recurrent Grade 4 Glioma Dose Escalation, Arm C: Newly-diagnosed Grade 4 Glioma
Glioblastoma Clinical Trial 2023: AZD1390 Highlights & Side Effects. Trial Name: NCT05182905 — Phase < 1
AZD1390 (ATM Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05182905 — Phase < 1
~10 spots leftby Nov 2025