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Spots Global Cancer Trial Database for Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation

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Trial Identification

Brief Title: Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation

Official Title: A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation

Study ID: NCT02481154

Conditions

Glioma

Interventions

AG881

Study Description

Brief Summary: This study evaluates the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in Gliomas, that harbor an IDH1 and/or IDH2 mutation.

Detailed Description: The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in gliomas, that harbor an IDH1and/or IDH2 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-881 to determine the maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where patients will receive AG-881 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. The anticipated time on study treatment is until disease progression, unacceptable toxicity occurs or the patient is removed at the discretion of the investigator

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

UCLA Oncology Center, Los Angeles, California, United States

University of California San Francisco, San Francisco, California, United States

University of Miami, Miami, Florida, United States

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

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

Duke University Medical Center, Durham, North Carolina, United States

Sarah Cannon Research Institute, Nashville, Tennessee, United States

MD Anderson Cancer Center, Dallas, Texas, United States

UT Southwestern Medical Center, Houston, Texas, United States

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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