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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
Participant has adequate bone marrow and organ function as defined by specific laboratory values
Age ≥18 at time of consent
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

Study Summary

This trial will test a new drug, AZD1390, for people with a certain type of brain cancer. Researchers will see how well the drug works on its own and in combination with standard radiation therapy.

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.Check my eligibility
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.See study design
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

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood tests show my organs and bone marrow are working well.
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I am 18 years old or older.
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I have a tumor that can be measured and is at least 1 cm big.
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I had surgery for a severe brain tumor and need radiation next.
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My seizures caused by the tumor are under control with stable medication.
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I can take care of myself but might not be able to do heavy physical work.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Adverse events
Deaths
Drug-related toxicity
+3 more

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

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,243 Previous Clinical Trials
288,525,857 Total Patients Enrolled
14 Trials studying Glioblastoma
966 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
10 Previous Clinical Trials
340 Total Patients Enrolled
7 Trials studying Glioblastoma
216 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies for participants in this experiment?

"According to the clinicaltrials.gov website, this trial is currently recruiting participants with an initial posting date of March 9th 2022 and a recent update on 10th March 2022."

Answered by AI

What ultimate objectives are being sought through this research endeavor?

"As provided by the study's sponsor, AstraZeneca, the primary outcome of this clinical trial will be monitored and measured over a Day 4 Intraoperative period. This is labeled as Phase 1b: Examine the rate of 6-month progression-free survival in recurrent GBM participants with demonstrated PK effect. In addition, secondary objectives are being researched such as Phase 0: To evaluate the relative pharmacokinetics (PK) of AZD1390 in CSF; Deaths counting both number and frequency; and Drug-related toxicity levels."

Answered by AI

What is the scope of participants in this experiment?

"Yes, the details on clinicaltrials.gov demonstrate that recruitment is currently underway for this medical study. It was first posted on March 9th 2022 and underwent its most recent update a day later. A total of 21 patients are being sought out from one trial centre."

Answered by AI
~12 spots leftby Mar 2025