RECRUITING

Safusidenib Phase 2 Study in IDH1 Mutant Glioma

Description

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.

Study Overview

Study Details

Study overview

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.

A Phase 2, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Patients With Isocitrate Dehydrogenase 1 (IDH1) Mutant Glioma

Safusidenib Phase 2 Study in IDH1 Mutant Glioma

Condition
Glioma
Intervention / Treatment

-

Contacts and Locations

Phoenix

St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States, 85013

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02214

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

New York

Columbia University Medical Center, New York, New York, United States, 10032

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Durham

Duke Cancer Institute, Durham, North Carolina, United States, 27710

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44106

Salt Lake City

Huntsman Cancer Insititute, University of Utah, Salt Lake City, Utah, United States, 84112

Charlottesville

UVA Health, Emily Couric Clinical Cancer Cente, Charlottesville, Virginia, United States, 22903

Participation Criteria

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.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Nuvation Bio Inc.,

    Study Record Dates

    2028-03-01