This is a 2-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 3 astrocytoma with high-risk features or Grade 4 IDH1-mutant astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double blind, and placebo controlled.
This is a 2-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 3 astrocytoma with high-risk features or Grade 4 IDH1-mutant astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double blind, and placebo controlled.
Safusidenib Phase 2 Study in IDH1 Mutant Glioma
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St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States, 85013
Massachusetts General Hospital, Boston, Massachusetts, United States, 02214
Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215
Columbia University Medical Center, New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065
Duke Cancer Institute, Durham, North Carolina, United States, 27710
Cleveland Clinic, Cleveland, Ohio, United States, 44106
Huntsman Cancer Insititute, University of Utah, Salt Lake City, Utah, United States, 84112
UVA Health, Emily Couric Clinical Cancer Cente, Charlottesville, Virginia, United States, 22903
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
No
Nuvation Bio Inc.,
2028-03-01