Phase 1/2 Open-Label Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX295 in Subjects with Wild-Type TP53 Advanced Solid Tumors
Study of ASTX295 in Patients With Solid Tumors
Sponsor: Astex Pharmaceuticals
Enrolling: Male and Female Patients
IRB Number: AAAS3955
U.S. Govt. ID: NCT03975387
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: The purpose of the study is to test the following: 1) The safety and tolerability (how you feel when you take the drug) of the study drug, 2) The pharmacokinetics (PK) (how the study drug is absorbed within your body, spread throughout your body, and eliminated from your body) of the study drug, 3) The pharmacodynamics (PD) (how the study drug affects certain proteins related to your cancer) of the study drug 4) The initial clinical effect (how the study drug affects your cancer) of the study drug, and 5) To determine the most appropriate dose (strength) and how often the drug should be taken. The drug being tested in this study, ASTX295, is investigational. This means it has not been approved for the treatment of cancer in any country. This is the first clinical study of ASTX295 in humans. In this study, all subjects will receive the study drug; there is no placebo treatment. There are 2 Phases in this study, Phase 1 (early stage) and Phase 2 (late-stage).
Investigator
Gary Schwartz, MD
Do You Qualify?
Do you have a solid tumor that continues to grow or cannot be removed via surgery, or for which standard therapy does not exist? Yes No
Are you a male or female 18 years of age or older? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162