113
Participants
Start Date
November 30, 2010
Primary Completion Date
May 31, 2013
Study Completion Date
December 31, 2013
ISIS EIF4E Rx
800 mg ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle.
ISIS EIF4E Rx
1000 mg ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle.
ISIS EIF4E Rx
(Dose identified in Part 1)ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle.
Prednisone
5 mg administered orally twice daily on days 1, 8, 15 and 22 of each cycle
Docetaxel
75 mg/m2 administered as a 1-hour intravenous infusion on day 1 of each cycle
Szent Janos Hospital and Unified Hospitals of North Buda, Budapest
Semmelweis University Faculty of Medicine, Budapest
National Institute of Oncology, Budapest
University of Pecs, Institute of Oncology, Pécs
Fejer County St. Gyorgy Hospital, Dept of Oncology, Székesfehérvár
St. Luke's - Roosevelt Hospital Center, New York
James P. Wilmont Cancer Center - University of Rochester Medical Center, Rochester
Fundeni Clinical Institute, Bucharest
University of Miami, Miller School of Medicine - Sylvester Comprehensive Cancer Center, Miami
Lakeland Regional Cancer Center, Lakeland
Central Baptist Hospital Clinical Research Center, Lexington
Gabrail Cancer Center, Canton
"Prof. Dr Th Burghele Clinical Hospital", Bucharest
Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport
Highlands Oncology Group, Fayetteville
Fort Range Cancer Center, Fort Collins
State Medical Institution of the City of Moscow: Municipal Clinical Hospital #57 under Moscow Department for Healthcare, Moscow
Non-State Medical Institution: Central Clinical Hospital #2 n.a. N.A. Semashko under OJSC Russian Railways, Chemotherapy Dpmt, Moscow
St. Petersburg State Medical Institution: St. Petersburg Municipal Oncological Center, Department of Urologic Oncology, Saint Petersburg
Russian Research Center for Radiology and Surgical Technologies, Saint Petersburg
SC Oncolab SRL, Medical Oncology Dept, Craiova
"Federal State Budget Institution: Medical Radiological Research Center under the Ministry of Health Care and Social Development of the Russian Federation", Obninsk
State Medical Institution: Kursk Regional Oncological Center, Chemotherapy Dept, Kursk
SC Medisprof SRL, Cluj-Napoca
Dr Constantin Opris Emergency County Hospital, Baia Mare
State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Clinical Oncology Center, Chemotherapy Department, Chelyabinsk
S.C. Rapid Diagnosis Polyclinic SRL, Brasov
Alba Lulia Emergency County Hospital, Alba Iulia
S.C. Provita 2000 SRL, Constanța
San Bernardino Urological Associates, San Bernardino
Norwalk Hospital- Whittingham Cancer Center, Norwalk
Ewa Pilecka Clinical Oncology Department and Outpatient Chemotherapy Unit, Bialostockie M.Sklodowska-Curie Oncology Centre in Bialystok, Bialystok
Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego, Oddzial Onkologii Klinicznej, Grudziądz
Department of Chemotherapy, Health Care Facility of the Ministry of Internal Affairs and Administration and Warminsko-Mazurskie Oncology Centre in Olsztyn, Olsztyn
Clinical Oncology Department and Day Hospitalization Unit, Independent Public Healthcare Facility T. Koszarowski Opolskie Oncology Centre in Opole, Opole
Department of Urologic Oncology, Maria Sklodowska-Curie Institute of Oncology, Warsaw
Clinical Oncology Department/Chemotherapy Department, MAGODENT Non-Public Healthcare Facility, Branch Facility No. 4, Warsaw
Fundacion de Investigacion de Diego, San Juan
Lead Sponsor
Ionis Pharmaceuticals, Inc.
INDUSTRY