107
Participants
Start Date
May 12, 2017
Primary Completion Date
May 15, 2020
Study Completion Date
June 24, 2020
SY-1365 (Part 1)
"Two dosing schedules will be evaluated in dose escalation and a dose(s)/schedule(s) will be determined for Part 2:~* Twice weekly: SY-1365 will be administered by intravenous infusion over 1 or 2 hours twice a week for 3 weeks of each 4 week (28 day) cycle.~* Weekly: SY-1365 will be administered by intravenous infusion over 1 or 2 hours once a week for 3 weeks of each 4 week (28 day) cycle."
Carboplatin
Carboplatin will be administered on Day 1 of each 3 week (21-day) cycle (Part 2 only)
Fulvestrant
Fulvestrant will be administered as an intramuscular (IM) dose of 500 mg every 2 weeks for the first 3 doses on Day 1 and Day 15 of the first 28-day cycle (Cycle 1), and on Day 1 of the second 28 day cycle (Cycle 2), and monthly thereafter starting on Day 1 of Cycle 3 (Part 2 only)
SY-1365 (Cohort 2)
In combination with carboplatin, SY-1365 will be administered by intravenous infusion over 1 or 2 hours for 2 weeks of each 3 week (21-day) cycle (Part 2 only)
SY-1365 (Cohort 5)
In combination with fulvestrant, SY-1365 will be administered by intravenous infusion over 1 or 2 hours once a week for 3 weeks of each 4 week (28-day) cycle (Part 2 only)
SY-1365 (Part 2 Single Agent)
SY-1365 will be administered by intravenous infusion over 1 or 2 hours twice a week for 3 weeks of each 4 week (28 day) cycle
Columbia University Medical Center, New York
University of Alabama at Birmingham, Birmingham
Tennessee Oncology, Nashville
University of Chicago Medical Center, Chicago
Stephenson Cancer Center, Oklahoma City
University of Texas Southwestern Medical Center, Dallas
Texas Oncology, Fort Worth
South Texas Accelerated Research Therapeutics, San Antonio
Texas Oncology, Austin
Honor Health Research Institute, Scottsdale
Palo Alto Medical Foundation Group, San Francisco
Willamette Valley Cancer Institute and Research Center, Eugene
Massachusetts General Hospital, Boston
Dana Farber Cancer Institute, Boston
Women and Infants Hospital of Rhode Island, Providence
Hamilton Health Sciences, Hamilton
McGill University Health Center, Montreal
Centre Léon Bérard, Lyon
Institut de Cancérologie de l'Ouest, Saint-Herblain
Institut Gustave Roussy, Villejuif
Lead Sponsor
Syros Pharmaceuticals
INDUSTRY