Spots Global Cancer Trial Database for Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma
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Trial Identification
Brief Title: Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma
Official Title: A Phase 0 'Trigger' Trial of Niraparib in Newly-diagnosed Glioblastoma and Recurrent IDH1/2(+) ATRX Mutant Glioma
Study ID: NCT05076513
Study Description
Brief Summary: This is an open-label, multi-center Phase 0 study with an expansion phase that will enroll up to 24 participants with newly-diagnosed glioblastoma and up to 18 recurrent glioma participants with IDH mutation and ATRX loss. The trial will be composed of a Phase 0 component (subdivided into Arm A and B) and a therapeutic expansion phase. Patients with tumors demonstrating a positive PK Response (in Arm A) or a positive PD Response (in Arm B) of the Phase 0 component of the study will graduate to a therapeutic expansion phase that combines therapeutic dosing of niraparib plus standard-of-care fractionated radiotherapy (in Arm A) or niraparib monotherapy (in Arm B) until progression of disease.
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
University of California San Francisco, San Francisco, California, United States
Contact Details
Name: Nader Sanai, MD
Affiliation: Chief Scientific Officer/Director of the Ivy Brain Tumor Center
Role: PRINCIPAL_INVESTIGATOR
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