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NCT03423628 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Recurrent Glioblastoma Multiforme and Primary Glioblastoma Multiforme, sponsored by AstraZeneca.

Recruiting
Registry status
Phase 1
Development phase
180
Enrollment target
12
Study locations

NCT03423628: Recruiting Phase 1 study of Recurrent Glioblastoma Multiforme and Primary Glioblastoma Multiforme, sponsored by AstraZeneca.

NCT03423628 is a Phase 1 study of Recurrent Glioblastoma Multiforme and Primary Glioblastoma Multiforme that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 180 participants, above the 74-participant average among 6 other Recurrent Glioblastoma Multiforme trials with a reported enrollment target (143% higher). The trial reports 12 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03423628, a Phase 1 study of Recurrent Glioblastoma Multiforme and Primary Glioblastoma Multiforme, is actively recruiting participants, sponsored by AstraZeneca.

RECRUITING
Registry status
Phase 1
Development phase
180 participants
Enrollment target
12
Study locations

Study Summary

This study will test an investigational drug called AZD1390 in combination with radiation therapy for the treatment of brain tumors. This is the first time AZD1390 is being given to patients. This study will test safety, tolerability and PK (how the drug is absorbed, distributed and eliminated) of ascending doses of AZD1390 in combination with distinct regimens of radiation therapy

Primary Outcome

DLTs will be used to calculate the maximum tolerated dose (MTD). In each arm, the MTD of AZD1390 is the highest dose at which the predicted probability of a DLT is less than 25% in that specific RT setting

Interventions

  • RADIATION Radiation Therapy
  • DRUG AZD1390

Study Locations (12)

Other

  • Research Site - Chūōku
  • Research Site - Hidaka-shi
  • Research Site - Kyoto
  • Research Site - Cambridge
  • Research Site - Glasgow
  • Research Site - Leeds
  • Research Site - London

Massachusetts

  • Research Site - Boston
  • Research Site - Boston

New York

  • Research Site - New York

Pennsylvania

  • Research Site - Pittsburgh

Virginia

  • Research Site - Richmond

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2018-04-02
Est. Completion 2026-09-16
Phase Phase 1
AstraZeneca

1,285 total trials

What NCT03423628 shows while recruiting

NCT03423628 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 74-participant average among 6 other Recurrent Glioblastoma Multiforme trials with a reported enrollment target (143% higher).

The record links to 4 conditions, with Recurrent Glioblastoma Multiforme appearing as the primary indexed condition, and to 2 interventions - of which Radiation Therapy is the first listed.

NCT03423628 lists 12 locations in 5 states (Other, Massachusetts, New York).

Frequently Asked Questions

What is clinical trial NCT03423628 about?

NCT03423628 is a clinical study titled "A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer". This study will test an investigational drug called AZD1390 in combination with radiation therapy for the treatment of brain tumors. This is the first time AZD1390 is being given to patients. This study will test safety, tolerability and PK (how the drug is absorbed, distributed and eliminated) of a...

What is the current status of trial NCT03423628?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 180 participants. The study started on 2018-04-02. Estimated completion is 2026-09-16.

What conditions does trial NCT03423628 study?

This clinical trial studies the following conditions: Recurrent Glioblastoma Multiforme, Primary Glioblastoma Multiforme, Brain Neoplasms, Malignant, Leptomeningeal Disease (LMD).

What interventions are being tested in trial NCT03423628?

The interventions under investigation include: Radiation Therapy (RADIATION), AZD1390 (DRUG).

Who is sponsoring clinical trial NCT03423628?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03423628 being conducted?

This trial has 12 study locations across Massachusetts, New York, Pennsylvania, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT03423628, the US trial registry maintained by the National Library of Medicine. NCT03423628 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.