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AZD1390 + Radiation Therapy for Brain Cancer

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

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

Study 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.

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 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,272 Previous Clinical Trials

288,612,555 Total Patients Enrolled

14 Trials studying Glioblastoma

883 Patients Enrolled for Glioblastoma

Mariza DarasPrincipal InvestigatorVCU Massey Cancer Center

Deborah ForstPrincipal InvestigatorMassachusetts General Hospital

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

Frequently Asked Questions

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

Does AZD1390 pose any risk to individuals who consume it?

"Based on the limited clinical evidence supporting AZD1390's safety and efficacy, our team has assigned it a score of 1."

Answered by AI

To whom is eligibility for this research project extended?

"This clinical trial seeks to recruit 120 individuals aged 18-130 years old who have been diagnosed with leptomeningeal disease. Furthermore, they must be able to attain a Karnofsky Performance Score of 60 or higher and possess histological evidence of GBM solid tumor malignancy which can be seen via Magnetic Resonance Imaging (MRI). Participants cannot receive Stereotactic Radiosurgery treatment for their brain tumors if accepted into this trial.Note that Arm B has now closed recruitment."

Answered by AI

What is the breadth of institutions currently undergoing this trial?

"Currently, the 4 sites recruiting for this medical trial are located in Pittsburgh, New york City, and Richmond. Additionally, there are other centres participating in recruitment efforts. It is suggested that interested patients select a nearby clinic to minimize their travel commitments if they decide to join the study."

Answered by AI

Is this research program still open to participants?

"According to information sourced from clinicaltrials.gov, this medical trial is still recruiting participants. It was first launched on April 2nd 2018 and the most recent update occurred November 3rd 2022."

Answered by AI

Are senior citizens qualified to partake in this trial?

"This research project is open to any individual over the age of majority and younger than 130 years old."

Answered by AI

What are the main objectives of this trial's research?

"The primary aim of this medical research is to assess the occurrence of adverse and serious events over an assigned duration (6 weeks for Arm A, 3 weeks for Arm B, and 10 weeks for Arm C). Supplementary objectives include ascertaining patients' response rate according to RECIST 1.1 criteria in now-closed arm B, determining response rate through RANO-BM criteria also exclusive to closed arm B, and measuring AZD1390's food effect on participants from open arm A with blood samples collected across multiple time points as a basis for area under curve analysis."

Answered by AI

How many individuals are being chosen to take part in this clinical study?

"Affirmative. According to clinicaltrials.gov, the research trial is still gathering candidates, having been first posted on April 2nd 2018 and most recently updated on November 3rd 2022. The project aims to enrol 120 individuals from 4 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer

2018. "A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03423628.

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