Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

630

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

July 31, 2016

Study Completion Date

July 31, 2016

Conditions
Prostate Cancer
Interventions
DRUG

cabazitaxel

Cabazitaxel (25mg/m² IV) is administered on day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or completion of 10 cycles

DRUG

prednisone

Prednisone (10 mg PO) is administered daily until disease progression, unacceptable toxicity, or completion of 10 cycles

DRUG

custirsen sodium

Custirsen is administered as 3 loading doses (640 mg IV each) within 9 days, followed by weekly custirsen (640 mg IV) during each 21-day cycle until disease progression, unacceptable toxicity, or completion of 10 cycles

Trial Locations (94)

Unknown

Prostate Oncology Specialists, Marina del Rey

University of California Davis Medical Center, Sacramento

Sharp Health Care, San Diego

California Pacific Medical Center Research Institute, San Francisco

Rocky Mountain Cancer Center, Boulder

Hartford Hospital, Hartford

Smilow Cancer Hospital at Yale New Haven Hospital, New Haven

The Center for Hematology-Oncology, Boca Raton

Florida Cancer Specialists, Fort Myers

Florida Cancer Specialists, Inverness

H. Lee Moffitt Cancer Center and Research Institute, Tampa

Georgia Cancer Specialists, P.C., Marietta

Cancer Center of Kansas, Wichita

Boston University Medical Center, Boston

University of Michigan Health System, Ann Arbor

Karmanos Cancer Institute, Detroit

Washington University School of Medicine, St Louis

Urology Cancer Center and GU Research Network, Omaha

Monter Cancer Center, Lake Success

SUNY Upstate Medical University, Syracuse

Albert Einstein Medical Center, The Bronx

Blumenthal Cancer Center, Charlotte

Cancer Centers of North Carolina, Raleigh

Oncology Hematology Care, Inc., Blue Ash

The Mark H. Zangmeister Center, Columbus

Oregon Health and Science University, Portland

South Carolina Oncology Associates, Columbia

Cancer Centers of the Carolinas, Greenville

Chattanooga Oncology and Hematology Associates, Chattanooga

The West Clinic, Memphis

Tennessee Oncology, PLLC, Nashville

Texas Oncology, PA, Dallas

Utah Cancer Specialists, Salt Lake City

Virginia Oncology Associates, Norfolk

Virginia Cancer Institute, Richmond

The Canberra Hospital, Garran

Royal Prince Alfred Hospital, Camperdown

St George Public Hospital, Kogarah

Royal North Shore Hospital, Saint Leonards

Westmead Hospital, Westmead

Haematology and Oncology Clinics of Australia, Brisbane

The Queen Elizabeth Hospital, Woodville South

Royal Hobart Hospital, Hobart

Box Hill Hospital, Box Hill

Austin Health, Heidelberg

Epworth Healthcare, Richmond

Cross Cancer Institute, Edmonton

British Columbia Cancer Agency, Vancouver

Juravinski Cancer Centre, Hamilton

London Health Sciences Center, London

R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health Oshawa, Oshawa

The Ottawa Hospital Regional Cancer Centre, Ottawa

Sunnybrook Health Sciences Centre, Toronto

CHUM-Hospital Notre-Dame, Montreal

Krajská nemocnice Liberec a.s., Liberec

Krajská nemo. T.Bati, a. s., Zlín

Fakultni nemo Hradec Králové, Hradec Králové

University Hospital Olomouc, Olomouc

Centre Léon Bérard, Lyon Cédex 08

Centre François Baclesse, Caen

Institut Jean-Godinot, Reims

Institut Paoli Calmettes, Marseille

Institut de Cancérologie de l'Ouest - René Gauducheau, Saint-Herblain

Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie, Poitiers

Centre Antoine Lacassagne, Nice

Hôpital Saint Louis, Paris

Institut Curie, Paris

Institut Gustave Roussy, Villejuif

Pándy Kálmán Megyei Kórház, Gyula

Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház, Miskolc

Országos Onkológiai Intézet, Budapest

Semmelweis Egyetem Általános Orvostudományi Kar, Budapest

Szegedi Tudományegyetem, Onkoterápiás Klinika, Szeged

Ivanovo Reg Oncology Centre, Ivanovo

Cancer Research Center na NN Blokhin, Moscow

Hertzen Rsrch Inst of Oncology, Moscow

Sverdlovsk Reg Clin Hosp#1, Yekaterinburg

Volgograd Regional Oncological Dispensary, Volzhsky

S Inst Hlth Altay Reg Onc Disp, Barnaul

Russian Research Center of Radiology, Moscow

Urology Research Institute, Moscow

State Healthcare Inst Omsk Reg, Omsk

Petrov Research Oncology Institute, Saint Petersburg

Saint Petersburg City Oncological Dispensary, Saint Petersburg

Stavropol Reg Oncology Ctr, Stavropol

Cancer Research UK, Birmingham

Addenbrookes Hospital Cambridge, Cambridge

U of Surrey Post Grad Med, Guildford

Christie Hospital NHS Foundation Trust, Manchester

Clatterbridge Centre for Oncology NHS Foundation Trust, Metropolitan Borough of Wirral

Nottingham City Hospital NHS Trust, Nottingham

The Royal Marsden Hospital, Surrey

Musgrove Park Hospital, Taunton

Beatson Cancer Centre, Glasgow, Glasgow

Sponsors
All Listed Sponsors
lead

Achieve Life Sciences

INDUSTRY