200
Participants
Start Date
April 30, 2013
Primary Completion Date
October 31, 2017
Study Completion Date
October 31, 2017
OGX-427
"Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.~Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Participants without documented disease progression who have discontinued from study treatment not due to toxicity related to OGX-427 can also continue to receive OGX-427 maintenance as long as they have completed disease assessments following at least 2 cycles of chemotherapy. Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity."
Docetaxel
"For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
New York University Clinical Cancer Center, New York
Memorial Sloan-Kettering Cancer Center: Main Campus, New York
Memorial Sloan-Kettering Cancer Center: Sleepy Hollow, Sleepy Hollow
Memorial Sloan-Kettering Cancer Center: Rockville Centre, Rockville Centre
Memorial Sloan-Kettering Cancer Center: Commack, Commack
Roswell Park Cancer Institute, Buffalo
University of Rochester Medical Center, Rochester
Thomas Jefferson University: Kimmel Cancer Center, Philadelphia
University of Maryland: Greenebaum Cancer Center, Baltimore
Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center, Baltimore
MUSC Hollings Cancer Center, Charleston
University of Alabama Hematology Oncology Clinic at Medical West, Birmingham
Lake Health: University Hospitals Seidman Cancer Center, Mentor
University Hospitals Seidman Cancer Center, Cleveland
UHHS Chagrin Highlands: Seidman Cancer Center, Orange
Cleveland Clinic: Taussig Cancer Institute, Cleveland
Indiana University Melvin & Bren Simon Cancer Center, Indianapolis
IU Health Central Indiana Cancer Centers, Indianapolis
IU Health Goshen Hospital, Goshen
IU Health at Ball Memorial Hospital, Muncie
University of Michigan Cancer Center, Ann Arbor
Froedtert & Medical College of Wisconsin, Milwaukee
Siteman Cancer Center, St Louis
Nebraska Cancer Specialists, Omaha
University of New Mexico Cancer Center: Albuquerque, Albuquerque
University of New Mexico Cancer Center: Las Cruces, Las Cruces
USC: Norris Comprehensive Cancer Center, Los Angeles
UCLA: Jonsson Comprehensive Cancer Center, Los Angeles
City of Hope: Duarte, Duarte
City of Hope: Antelope Valley, Lancaster
Dana-Farber Cancer Institute, Boston
Dartmouth-Hitchcock Medical Center: Norris Cotton Cancer Center, Manchester
Memorial Sloan-Kettering Cancer Center: Basking Ridge, Basking Ridge
John Theurer Cancer Center: Hackensack University Medical Center, Hackensack
Rutgers Cancer Institute of New Jersey, New Brunswick
Collaborators (2)
Achieve Life Sciences
INDUSTRY
Hoosier Cancer Research Network
OTHER
Noah Hahn, M.D.
OTHER