Spots Global Cancer Trial Database for AZD1390 in Recurrent and Newly Diagnosed WHO Grade 4 Glioma Patients
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Trial Identification
Brief Title: AZD1390 in Recurrent and Newly Diagnosed WHO Grade 4 Glioma Patients
Official Title: A Phase 0/1b, Single Center, Clinical Trial With an Expansion Phase of AZD1390 Plus Fractionated Radiotherapy in Recurrent and Newly Diagnosed WHO Grade 4 Glioma Patients
Study ID: NCT05182905
Interventions
Study Description
Brief Summary: This is an open-label, single-center Phase 0/1b study that will enroll at least 17 participants with recurrent WHO Grade 4 Glioma requiring re-radiation and approximately 20 participants with newly-diagnosed WHO Grade 4 glioma (nGBM). The trial will be composed of a Phase 0 component (subdivided into Arms A- C), and an expansion Phase 1b. Patients with tumors demonstrating a positive PK response in the Phase 0 component of the study will graduate to an expansion phase that combines therapeutic dosing of AZD1390 plus standard-of-care fractionated radiotherapy (RT).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
Contact Details
Name: Nader Sanai, MD
Affiliation: Chief Scientific Officer/Director
Role: PRINCIPAL_INVESTIGATOR
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