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AZD1390 + Radiation Therapy for Brain Cancer

Chuo-ku, Japan
Phase 1
Recruiting
Led By Mariza Daras
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Determination of MGMT promoter status by methylation-specific polymerase chain reaction (PCR) or pyrosequencing per local institutional guidelines is required to assess eligibility for Arm C
Histologically proven diagnosis of solid tumor malignancy and Magnetic Resonance (MR) imaging documenting brain lesions for Arm B
Must not have
Cardiac dysfunction defined as: Myocardial infarction within six months of study entry, NYHA (New York Heart Association) Class II/III/IV heart failure, unstable angina, unstable cardiac arrhythmias
Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks starting from 4 weeks after rt until the end of the study (approximately 1 year)
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of a new drug, AZD1390, for treating brain tumors.

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Who is the study for?
This trial is for adults with brain cancer who have completed first-line radiation at least 6 months ago, are willing to take anti-epileptic drugs if needed, and have their disease under control. They must not have had recent chemotherapy or certain other treatments and should be able to undergo MRI scans. People with severe medical conditions, a history of significant brain injury or stroke, uncontrolled seizures, or those on strong CYP3A4 inhibitors/inducers are excluded.Check my eligibility
What is being tested?
The study tests AZD1390 in combination with radiation therapy on patients with brain tumors. It's the first time this drug is being used on humans and will assess its safety and how it's processed by the body when given in different doses alongside various radiation schedules.See study design
What are the potential side effects?
Since AZD1390 is investigational and new to human trials, specific side effects aren't fully known yet but may include typical reactions related to similar therapies such as fatigue, skin irritation from radiation, nausea, headaches or potential neurological effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer's MGMT promoter status has been tested.
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I have a confirmed solid tumor cancer and brain lesions shown by an MRI.
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I cannot have precise radiation therapy for my brain tumor.
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I have not had seizures caused by brain metastases or LMD.
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My seizures caused by a tumor are under control with stable medication.
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I have a confirmed diagnosis of GBM for treatment Arm A.
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I can provide a tissue sample from my cancer.
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My GBM diagnosis is confirmed and my MGMT gene is unmethylated.
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I am able to care for myself but may not be able to do active work.
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I don't have uncontrolled seizures or take more than 2 seizure medications for my brain tumor.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a heart attack or severe heart issues in the last 6 months.
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I have had lung conditions that needed steroid treatment.
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I haven't taken lung-damaging drugs like busulfan or bleomycin in the last year.
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I have Type I, Type II, or steroid-induced diabetes.
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I have a history of epilepsy or seizures not caused by my tumor.
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I have a muscle disorder or my muscle enzyme levels are high.
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I have had a severe brain injury or stroke.
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I do not have any severe illnesses like bad lung disease.
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I am currently on systemic steroid treatment for Arm A.
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I am currently taking medication that can cause seizures.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks starting from 4 weeks after rt until the end of the study (approximately 1 year)
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks starting from 4 weeks after rt until the end of the study (approximately 1 year) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Incidence of dose-limiting toxicities (DLTs)
Secondary study objectives
Area under the plasma concentration-time curve (AUC) for AZD1390
Assessment of the food effect of AZD1390 at the MTD for Arm A (if conducted)
Upper arm
+7 more

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: AZD1390 + Radiation TherapyExperimental Treatment2 Interventions
AZD1390 + Radiation Therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2004
Completed Phase 3
~7740

Find a Location

Closest Location:Research Site· Pittsburgh, PA· 166 miles

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,485 Previous Clinical Trials
290,541,727 Total Patients Enrolled
14 Trials studying Glioblastoma
943 Patients Enrolled for Glioblastoma
Mariza DarasPrincipal InvestigatorVCU Massey Cancer Center
Deborah ForstPrincipal InvestigatorMassachusetts General Hospital
Paul MulhollandPrincipal InvestigatorUniversity College London Hospitals
2 Previous Clinical Trials
68 Total Patients Enrolled
2 Trials studying Glioblastoma
68 Patients Enrolled for Glioblastoma
Jan DrappatzPrincipal InvestigatorUPMC Hospital Radiation Oncology
Timothy HarrisPrincipal InvestigatorVCU Massey Cancer Center
Alicia ZukasPrincipal InvestigatorVCU Massey Cancer Center
David Anthony ClumpPrincipal InvestigatorUPMC Hospital Radiation Oncology
Gary DohertyPrincipal InvestigatorCambridge University Hospitals NHS Foundation Trust
Jonathon YangPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Radiation Therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03423628 — Phase 1
Glioblastoma Research Study Groups: AZD1390 + Radiation Therapy
Glioblastoma Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT03423628 — Phase 1
Radiation Therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03423628 — Phase 1
~30 spots leftby Sep 2026
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