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AZD1390 for Glioblastoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- 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
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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