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AZD1390 + Radiation Therapy for Brain Cancer

Phase 1

Recruiting

Led By Paul Mulholland

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

Summary

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

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 8 weeks starting from 4 weeks after rt until the end of the study (approximately 1 year)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events (AEs) and serious adverse events (SAEs)

Incidence of dose-limiting toxicities (DLTs)

Secondary outcome measures

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

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

2017

Completed Phase 3

~7250

0 / 20Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,302 Previous Clinical Trials

288,624,479 Total Patients Enrolled

14 Trials studying Glioblastoma

883 Patients Enrolled for Glioblastoma

Paul MulhollandPrincipal InvestigatorUniversity College London Hospitals

1 Previous Clinical Trials

1 Total Patients Enrolled

1 Trials studying Glioblastoma

1 Patients Enrolled for Glioblastoma

Jan DrappatzPrincipal InvestigatorUPMC Hospital Radiation Oncology

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

~25 spots leftby Apr 2026

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