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Brief Title: A Study of ZN-c5 in Subjects With Breast Cancer
Official Title: A Phase 1/2 Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of ZN-c5 Alone and in Combination With Palbociclib in Subjects With Estrogen-Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer
Study ID: NCT03560531
Brief Summary: This is a Phase 1/2, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-c5 administered orally in subjects with advanced estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer. ZN-c5 will be evaluated both as monotherapy and in combination with palbociclib (IBRANCE®).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Site 3, Tucson, Arizona, United States
Site 5, Los Angeles, California, United States
Site 48, Bethesda, Maryland, United States
Site 47, Saint Louis, Missouri, United States
Site 7, New York, New York, United States
Site 2, New York, New York, United States
Site 50, Charleston, South Carolina, United States
Site 4, Nashville, Tennessee, United States
Site 1, Houston, Texas, United States
Site 8, Houston, Texas, United States
Site 6, Seattle, Washington, United States
Site 46, Minsk, , Belarus
Site 45, Vitebsk, , Belarus
Site 10, Banja Luka, , Bosnia and Herzegovina
Site 9, Sarajevo, , Bosnia and Herzegovina
Site 11, Tuzla, , Bosnia and Herzegovina
Site 29, Brno, , Czechia
Site 28, Olomouc, , Czechia
Site 30, Praha 5, , Czechia
Site 51, Budapest, , Hungary
Site 35, Kecskemét, , Hungary
Site 37, Pécs, , Hungary
Site 17, Kaunas, , Lithuania
Site 16, Vilnius, , Lithuania
Site 42, Ekaterinburg, , Russian Federation
Site 40, Nizhniy Novgorod, , Russian Federation
Site 52, Omsk, , Russian Federation
Site 41, Pyatigorsk, , Russian Federation
Site 39, Saint Petersburg, , Russian Federation
Site 18, Belgrade, , Serbia
Site 19, Belgrade, , Serbia
Site 21, Niš, , Serbia
Site 20, Novi Sad, , Serbia
Site 25, Cherkasy, , Ukraine
Site 27, Kharkiv, , Ukraine
Site 24, Kropyvnytskyi, , Ukraine
Site 26, Kryvyi Rih, , Ukraine
Site 23, Kyiv, , Ukraine
Name: Zeno Alpha, Inc.
Affiliation: Zeno Alpha Inc.
Role: STUDY_DIRECTOR