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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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 month progression-free survival (pfs6) rate measured from the time of surgery to date of recurrence.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month progression-free survival (pfs6) rate measured from the time of surgery to date of recurrence.
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 moreAwards & 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.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood tests show my organs and bone marrow are working well.I can take pills by mouth.I have risk factors for abnormal heart rhythms.I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.I am 18 years old or older.I have had lung conditions caused by drugs, disease, or radiation.I don't have severe side effects from previous treatments.I have a tumor that can be measured and is at least 1 cm big.I am having surgery for a suspected Grade 4 brain tumor and will need radiation afterwards.My heart's electrical activity is normal and I don't have a long QT interval.I do not have any serious health conditions that would stop me from joining the study.I had surgery for a severe brain tumor and need radiation next.My seizures caused by the tumor are under control with stable medication.I am a man who can father children and will use effective birth control.I haven't taken lung-damaging drugs in the last year.I haven't taken strong CYP3A4 inhibitors or inducers in the last 2 weeks.I have a history of muscle disorders or high levels of muscle enzymes.I have previously been treated with ATM kinase inhibitors.I do not have any severe infections, liver disease, or active infections.I am willing to take seizure prevention medication during the study.I can take care of myself but might not be able to do heavy physical work.I have a history of epilepsy or seizures not caused by a tumor.I am currently using a blood thinner that can't be stopped before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Recurrent Grade 4 Glioma Surgical Cohort Time Escalation
- Group 2: Arm B: Recurrent Grade 4 Glioma Dose Escalation
- Group 3: Arm C: Newly-diagnosed Grade 4 Glioma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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