Spots Global Cancer Trial Database for Randomized Phase 2 Study of Atezolizumab and Entinostat in Patients With aTN Breast Cancer With Phase 1b Lead In
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Trial Identification
Brief Title: Randomized Phase 2 Study of Atezolizumab and Entinostat in Patients With aTN Breast Cancer With Phase 1b Lead In
Official Title: A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 2 Study of Atezolizumab With or Without Entinostat in Patients With Advanced Triple Negative Breast Cancer, With a Phase 1b Lead in Phase
Study ID: NCT02708680
Conditions
Study Description
Brief Summary: The purpose of this study is to determine the safety and tolerability of entinostat used in combination with atezolizumab in participants with Advanced Triple Negative Breast Cancer (aTNBC). Additionally, the purpose of the study is to assess how effective entinostat and atezolizumab are in combination in participants with aTNBC.
Detailed Description: SNDX-275-0602 is a Phase 1b/2 study evaluating the combination of entinostat plus atezolizumab in participants with aTNBC. The study has 2 phases: an open-label Dose Determination Phase (Phase 1b) followed by an Expansion Phase (Phase 2). The Expansion Phase will evaluate the efficacy and safety of entinostat when administered at the RP2D with atezolizumab in participants with aTNBC in a randomized, double-blind, placebo-controlled setting. Safety will be assessed during the study by documentation of AEs, clinical laboratory tests, physical examinations, vital sign measurements, electrocardiograms (ECGs), and Eastern Cooperative Oncology Group (ECOG) performance status. Adverse events of special interest (AESI) will be collected and reviewed in a manner consistent with serious adverse event reporting procedures.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
UAB Comprehensive Cancer Center, Birmingham, Alabama, United States
CBCC Global Research at Comprehensive Blood and Cancer Center, Bakersfield, California, United States
St. Jude Medical Center, Fullerton, California, United States
Los Angeles Hematology Oncology Medical Group, Glendale, California, United States
Torrance Memorial Cancer Care Associates, Redondo Beach, California, United States
SLO Oncology and Hematology Health Center, San Luis Obispo, California, United States
Central Coast Medical Oncology Group, Santa Maria, California, United States
UCLA Hematology/Oncology - Santa Monica, Santa Monica, California, United States
Saint Mary's Regional Cancer Center, Grand Junction, Colorado, United States
Office of Human Research, Hollywood, Florida, United States
Orlando Health, Inc., Orlando, Florida, United States
Ft. Wayne Hematology and Oncology, Fort Wayne, Indiana, United States
Ft. Wayne Medical Oncology & Hematology, Inc, Fort Wayne, Indiana, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Frauenshuh Cancer Center at Park Nicollet Health Service, Saint Louis Park, Minnesota, United States
Saint Barnabas Medical Cancer Center, Livingston, New Jersey, United States
Hope Women's Cancer Centers, Asheville, North Carolina, United States
Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Cancer Center of Adjara Autonomous Republic, Batumi, Adjara, Georgia
Saint Nikolozi Surgery and Oncological Centre, Kutaisi, Imereti, Georgia
Unimed Adjara - Oncology Center, Kutaisi, Imereti, Georgia
Health House, Tbilisi, , Georgia
Institute of Clinical Oncology, Tbilisi, , Georgia
New Vision University Hospital, Tbilisi, , Georgia
Cancer Research Center, Tbilisi, , Georgia
S. Khechinashvili, University Hospital, Tbilisi, , Georgia
Multiprofile Clinic Consilium Medulla, Tbilisi, , Georgia
Research Institute of Clinical Medicine, Tbilisi, , Georgia
Contact Details
Name: Dennis Slamon, MD
Affiliation: University of California, Los Angeles
Role: PRINCIPAL_INVESTIGATOR
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