183
Participants
Start Date
October 31, 2011
Primary Completion Date
November 30, 2014
Study Completion Date
November 30, 2014
OGX-427 600 mg
Patients will receive three loading doses of 600 mg Study Drug within a 9-day period. Following the loading dose period, patients will receive weekly Study Drug infusions (600 mg IV) on Days 1, 8 and 15 of each 21-day cycle.
OGX-427 1000 mg
Patients will receive three loading doses of 600 mg Study Drug within a 9-day period. Following the loading dose period, patients will receive weekly Study Drug infusions (1000 mg IV) on Days 1, 8 and 15 of each 21-day cycle.
Placebo
Patients will receive three loading doses of placebo within a 9-day period. Following the loading dose period, patients will receive weekly placebo infusions (IV) on Days 1, 8 and 15 of each 21-day cycle.
Gemcitabine
Patients will receive gemcitabine (1000 mg/m\^2) for up to 6 cycles administered IV on Days 1 and 8 of each 21-day cycle following Study Drug infusion. The Cycle 1, Day 1 administration of chemotherapy must occur within 5 days of the third loading dose of Study Drug.
Cisplatin
Following the administration of gemcitabine on Day 1, cisplatin (70 mg/m\^2) will be administered IV for up to 6 cycles. The Cycle 1, Day 1 administration of chemotherapy must occur within 5 days of the third loading dose of Study Drug.
Carboplatin
Following the administration of gemcitabine on Day 1, cisplatin (70 mg/m\^2) is to be administered IV for up to 6 cycles; however, carboplatin could be substituted for cisplatin for some unacceptable toxicities. The Cycle 1, Day 1 administration of chemotherapy must occur within 5 days of the third loading dose of Study Drug.
City of Hope National Medical Center, Duarte
Cedars-Sinai Medical Center, Los Angeles
University of California Los Angeles, Los Angeles
USC Norris Comprehensive Cancer Center, Los Angeles
Radiological Associates of Sacramento, Sacramento
Yale University, New Haven
Karmanos Cancer Institute, Detroit
Siteman Cancer Center, Washington University School of Medicine, St Louis
Urology Cancer Center and GU Research Network, Omaha
Monter Cancer Center, Lake Success
Columbia University Medical Center, New York
Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx
Texas Oncology, P.A., Dallas
Seattle Cancer Care Alliance, Seattle
Tom Baker Cancer Center, Calgary
Cross Cancer Center, Edmonton
British Columbia Cancer Agency, Vancouver
Juravinski Cancer Centre, Hamilton
R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health, Oshawa
Princess Margaret Hospital, Toronto
CHUM-Hospital Notre Dame, Montreal
Centre Hospitalier Régional et Universitaire - Hôpital, Bretonneau Tours
Institute Jean Godinot, Reims
Centre Hospitalier Universitaire de Rouen, Rouen
Centre Paul Papin, Angers
Medicale Centre René Gauducheau, Saint-Herblain
Institut Paoli Calmettes, Marseille
Centre Antoine Lacassagne, Nice
Centre Hospitalier Universitaire, Institut Gustave Roussy, Villejuif
Universitätsklinikum Heidelberg, Heidelberg
Klinikum Rechts der Isar der Technischen Universität, München
Johann-Wolfgang-Goethe-Universität Frankfurt, Frankfurt am Main
Medizinische Hochschule Hannover, Hanover
Universitätsklinikum des Saarlandes, Homburg
Universitätsklinikum Dresden, Dresden
Universitätsklinikum Magdeburg A.ö.R., Magdeburg
Universitätsklinikum Jena, Jena
Universitätsklinikum Mainz, Mainz
Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena
Fondazione IRCCS Policlinico San Matteo Pavia, Pavia
Unità Operativa di Oncologia Medica, Roma
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy, Bydgoszcz
Akademicki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu, Wroclaw
NZOZ Europejskie Centrum Zdrowia Otwock, Otwock
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Warsaw
Uniwersyteckie Centrum Kliniczne, Gdansk
Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie, Olsztyn
Hospital Santa Creu i Sant Pau, Barcelona
Hospital General Universitario Gregorio Marañon, Madrid
Hospital Universitario 12 de Octubre, Madrid
Hospital Clinic I Provincial de Barcelona, Barcelona
Hospital del Mar, Barcelona
Hospital Vall d´Hebrón, Barcelona
Institut Català D'Oncologia, Hospital Duran i Reynals, Madrid
Instituto Valenciano de Oncología-Fundación (IVO-FINCIVO), Valencia
Lead Sponsor
Collaborators (1)
PRA Health Sciences
INDUSTRY
Achieve Life Sciences
INDUSTRY