Condition: Glioma · Astrocytoma, Grade IV · IDH1-mutant Glioma · Sponsor: Nuvation Bio Inc.
This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent/progressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma. The purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 2 or Grade 3 astrocytoma with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double-blind, and placebo-controlled. The purpose of Part 3 will be to evaluate the efficacy of safusidenib in participants with residual or recurrent IDH1-mutant Grade 3 oligodendroglioma who have received surgery as their only treatment. Part 3 will be an open-label single-arm cohort and will enroll participants concurrently with Part 2.
This description comes directly from the study's public registry record.
Clinical Trials at Nuvation Bio · 332-208-6102 · ClinicalTrials@nuvationbio.com
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| University of Alabama | Birmingham, Alabama, United States | Recruiting |
| Mayo Clinic - Arizona | Phoenix, Arizona, United States | Recruiting |
| St. Joseph's Hospital and Medical Center | Phoenix, Arizona, United States | Recruiting |
| University of California San Diego | La Jolla, California, United States | Not Yet Recruiting |
| University of California, Los Angeles | Los Angeles, California, United States | Recruiting |
| Hoag Memorial Hospital Presbyterian | Newport Beach, California, United States | Recruiting |
| Stanford University | Palo Alto, California, United States | Recruiting |
| University of California | San Francisco, California, United States | Recruiting |
| University of Colorado Health Cancer Care | Aurora, Colorado, United States | Recruiting |
| Yale University | New Haven, Connecticut, United States | Recruiting |
| University of Florida Health | Gainesville, Florida, United States | Recruiting |
| Mayo Clinic - Florida | Jacksonville, Florida, United States | Recruiting |
+ 45 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05303519