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Brief Title: A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer
Official Title: A Phase Ib/II Study of Intermittent Talazoparib Plus Temozolomide in Patients With Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair
Study ID: NCT04019327
Brief Summary: The purpose of this study is to determine what the safest dose of talazoparib plus temozolomide for participants with metastatic castration resistant prostate cancer. The purpose of Phase II is to test the efficacy (effectiveness) of talazoparib and temozolomide at the maximum tolerated dose, which was determined to be 1mg talazoparib and 75mg/m² temozolomide in the Phase Ib portion of this study.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States
Memorial Sloan Kettering Commack (Limited protocol activity), Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, United States
Lehigh Valley Health Network (Data Collection Only), Allentown, Pennsylvania, United States
University of Virginia, Charlottesville, Virginia, United States
University of Wisconsin, Madison, Wisconsin, United States
Name: Karen Autio, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR