View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
March 17, 2022

Ivy Brain Tumor Center begins trial of AstraZeneca’s therapy for glioma

The open-label, single-centre trial will analyse AZD1390 in up to 21 subjects with a recurrent glioma who need re-radiation.

The Ivy Brain Tumor Center at the Barrow Neurological Institute in the US has launched a Phase 0/Ib clinical trial of AstraZeneca’s AZD1390 in recurrent grade IV glioma patients. 

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

AZD1390 is an inhibitor of Ataxia telangiectasia mutant (ATM) kinase. 

The open-label, single-centre trial will enrol up to 21 subjects with a recurrent glioma who need re-radiation.  

The Ben and Catherine Ivy Foundation and the Barrow Neurological Foundation’s individual donors are funding the trial.

Validating the blood-brain barrier penetration of AZD1390 and analysing if it can boost the efficacy of radiation therapy are the goals of the trial.

Subjects with tumours showing favourable pharmacokinetics (PK) response in the Phase 0 segment of the trial will advance to the expansion Phase Ib portion.

AZD1390 will be administered along with the standard of care fractionated radiotherapy in the Phase Ib portion.

Based on findings from the active Phase I multicentre trial of AZD1390 currently underway, the maximum safe dose-level of the drug will be chosen for the Phase 0 trial.

This Phase I trial is analysing the safety, tolerability and systemic pharmacokinetics of ascending doses of AZD1390 along with radiation therapy for brain cancer patients. 

Ivy Brain Tumor Center chief operating officer and deputy director Shwetal Mehta said: “AZD1390 is a novel agent by AstraZeneca, specifically designed to cross the blood-brain barrier. 

“The drug targets ATM kinase, an essential factor that promotes the repair of DNA double-strand breaks caused by radiation treatment.” 

The US Food and Drug Administration introduced the Phase 0 trial approach in 2004 to expedite the assessment and approval process of drugs and enhance new therapies to enter the clinic. 

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena