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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActiveNot specifiedPharmaceutical / IndustryOGX-011-12
NCT01578655

Trial Description

Summary

This Phase 3 study has been designed to confirm that adding custirsen to cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter, international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs. cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal probability to the two arms.

Further Study Information

Until recently, options for second-line chemotherapy in CRPC have included docetaxel retreatment, mitoxantrone, or other chemotherapies, without proven clinical benefit. In 2010, a Phase 3 second-line chemotherapy trial (TROPIC) showed a survival advantage for cabazitaxel, a semi-synthetic taxane selected to overcome the emergence of taxane resistance, when compared to mitoxantrone.

Clusterin is a stress-activated cytoprotective chaperone up-regulated by a variety of anti-cancer therapies that confers treatment resistance when over-expressed. Inhibition of clusterin expression using custirsen has been shown to enhance tumor cell death following treatment with chemotherapy.

The clinical activity of custirsen in combination with the taxane docetaxel has been shown in two Phase 2 studies. Given the results observed using a taxane as either first-line or second-line chemotherapy in CRPC, combination with custirsen may decrease taxane resistance and enhance the survival benefit of taxane therapy. Thus, a combination of custirsen with cabazitaxel may further enhance survival in second-line taxane chemotherapy for CRPC.

Eligibility Criteria

Inclusion Criteria:

  • Histological or cytological diagnosis of adenocarcinoma of the prostate
  • Metastatic disease on chest, abdominal, or pelvic CT scan and/or bone scan
  • Previous first-line treatment for CRPC with a docetaxel-containing regimen
  • Current progressive disease
  • Increasing serum PSA level (for patients who progress based only on increasing serum PSA level, a minimum starting value of 5.0 ng/mL is required)
  • Baseline laboratory values as defined
  • Willing to continue primary androgen suppression with gonadotropin-releasing hormone (GnRH) analogues (unless treated with bilateral orchiectomy)
  • Karnofsky score ≥70%
  • At least 21 days have passed since completing radiotherapy
  • At least 21 days have passed since receiving any investigational agent at the time of randomization
  • At least 21 days have passed since major surgery
  • Recovered from any docetaxel therapy-related neuropathy to ≤grade 1 at the time of randomization
  • Recovered from all therapy related toxicity to ≤grade 2 (except alopecia, anemia, and any signs or symptoms of androgen deprivation therapy) at the time of randomization
  • Able to tolerate a starting dose of 25 mg/m² cabazitaxel
  • Willing to not add, delete, or change current bisphosphonate or denosumab usage
  • Able to tolerate oral prednisone at 10 mg per day
  • Competent to provide written informed consent

Exclusion Criteria:

  • Received any other cytotoxic chemotherapy beyond the first-line docetaxel-containing regimen as treatment for prostate cancer
  • Received prior radioisotope with strontium 89 or samarium 153
  • Received any cycling, intermittent, or continuous hormonal treatment within 21 days prior to randomization with the exception of the continuous GnRH analogues (prior treatment with abiraterone or MDV3100 is allowed as long as 21 days have passed since last dose)
  • Participated in a prior Phase 3 clinical study evaluating custirsen regardless of study arm assignment
  • Requiring ongoing treatment during the study with medications known to be either strong CYP3A inhibitors or strong CYP3A inducers
  • History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated
  • Current symptomatic cord compression requiring surgery or radiation therapy
  • Active second malignancy (except non melanomatous skin or superficial bladder cancer) defined in general as requiring anticancer therapy or at high risk of recurrence during the study
  • Uncontrolled medical condition or significant concurrent illness that in the opinion of the Investigator would preclude protocol therapy
  • Known severe hypersensitivity to taxanes or polysorbate 80-containing drugs
  • Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device

Trial Contact Information

Trial Lead Organizations/Sponsors

OncoGenex Technologies, Incorporated

Teva Pharmaceutical Industries, Limited

Tomasz M. BeerPrincipal Investigator

Karim Fazazi, MDPrincipal Investigator

Sebastien HottePrincipal Investigator

Daniel CainPh: 425-686-1546
  Email: dcain@oncogenex.com

Trial Sites

U.S.A.
California
  Marina Del Rey
 Prostate Oncology Specialists
  Sacramento
 University of California Davis Cancer Center
  San Diego
 Sharp Health Care
  San Francisco
 California Pacific Medical Center Research Institute
Colorado
  Boulder
 Rocky Mountain Cancer Center
Connecticut
  Hartford
 Helen and Harry Gray Cancer Center at Hartford Hospital
  New Haven
 Yale Cancer Center
Florida
  Boca Raton
 The Center for Hematology-Oncology
  Fort Myers
 Florida Cancer Specialists - Fort Myers Broadway
  Inverness
 Florida Cancer Specialists
  Tampa
 H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Georgia
  Marietta
 Georgia Cancer Specialist - Marietta
Kansas
  Wichita
 Cancer Center of Kansas, PA - Wichita
Massachusetts
  Boston
 Boston University Cancer Research Center
Michigan
  Ann Arbor
 University of Michigan Comprehensive Cancer Center
  Detroit
 Barbara Ann Karmanos Cancer Institute
Missouri
  St. Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Nebraska
  Omaha
 Urology Cancer Center, PC
New York
  Bronx
 Albert Einstein Cancer Center at Albert Einstein College of Medicine
  Lake Success
 Monter Cancer Center
  Syracuse
 SUNY Upstate Medical University Hospital
North Carolina
  Charlotte
 Blumenthal Cancer Center at Carolinas Medical Center
  Raleigh
 Cancer Centers of North Carolina
Ohio
  Blue Ash
 Oncology Hematology Care, Inc.
  Columbus
 The Mark H. Zangmeister Center
Oregon
  Portland
 Knight Cancer Institute at Oregon Health and Science University
South Carolina
  Columbia
 South Carolina Oncology Associates, PA
  Greenville
 Cancer Centers of the Carolinas - Eastside
Tennessee
  Chattanooga
 Chattanooga Oncology and Hematology Associates
  Memphis
 West Clinic - East Memphis
  Nashville
 Tennessee Oncology, PLLC
Texas
  Dallas
 Texas Oncology, PA
Utah
  Salt Lake City
 Utah Cancer Specialists at UCS Cancer Center
Virginia
  Norfolk
 Virginia Oncology Associates - Lake Wright
  Richmond
 Virginia Cancer Institute
Australia
Australian Capital Territory
  Garran
 The Canberra Hospital
New South Wales
  Camperdown
 Sydney Cancer Centre at Royal Prince Alfred Hospital
  Kogarah
 St George Public Hospital
  Saint Leonards
 Royal North Shore Hospital
  Westmead
 Westmead Institute for Cancer Research at Westmead Hospital
Queensland
  Brisbane
 Haematology and Oncology Clinics of Australia
South Australia
  Woodville South
 The Queen Elizabeth Hospital
Tasmania
  Hobart
 Royal Hobart Hospital
Victoria
  Box Hill
 Box Hill Hospital
  Heidelberg
 Austin Health
  Richmond
 Epworth Healthcare
Canada
Alberta
  Edmonton
 Cross Cancer Institute at University of Alberta
British Columbia
  Vancouver
 British Columbia Cancer Agency - Vancouver Cancer Centre
Ontario
  Hamilton
 Margaret and Charles Juravinski Cancer Centre
  London
 London Regional Cancer Program at London Health Sciences Centre
  Oshawa
 R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health Oshawa
  Ottawa
 Ottawa Hospital Regional Cancer Centre - General Campus
  Toronto
 Odette Cancer Centre at Sunnybrook
Quebec
  Montréal
 CHUM-Hospital Notre-Dame
Czech Republic
  Hradec Králové
 Fakultni nemo Hradec Králové
  Liberec
 Krajská nemocnice Liberec a.s.
  Olomouc
 University Hospital - Olomouc
  Zlín
 Krajská nemo. T.Bati, a. s.
France
  Caen cedex 05
 Centre François Baclesse
  Lyon cédex 08
 Centre Léon Bérard
  Marseille
 Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
  Nice Cedex 2
 Centre Antoine Lacassagne
  Paris
 Hopital Saint-Louis
  Paris Cedex 05
 Institut Curie
  Poitiers Cedex
 Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie
  Reims
 Institut Jean-Godinot
  Saint Herblain
 Centre Regional Rene Gauducheau
  Villejuif
 Institut Gustave Roussy
Hungary
  Budapest
 Országos Onkológiai Intézet
 Semmelweis University
  Gyula
 Pándy Kálmán Megyei Kórház
  Miskolc
 Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház
  Szeged
 Szegedi Tudományegyetem, Onkoterápiás Klinika
Russia
  Barnaul
 S Inst Hlth Altay Reg Onc Disp
  Ekaterinburg
 Sverdlovsk Reg Clin Hosp#1
  Ivanovo
 Ivanovo Reg Oncology Centre
  Moscow
 Cancer Research Center na NN Blokhin
 Hertzen Rsrch Inst of Oncology
 Russian Research Center for Roentgen Radiology
 Urology Research Institute
  Omsk
 State Healthcare Inst Omsk Reg
  Saint Petersburg
 Petrov Research Institute of Oncology
 Saint Petersburg City Oncological Dispensary
  Stavropol
 Stavropol Reg Oncology Ctr
  Volzhskiy
 Volgograd Regional Oncological Dispensary
United Kingdom
England
  Birmingham
 Cancer Research UK
  Cambridge
 Addenbrooke's Hospital
  Guildford
 U of Surrey Post Grad Med
  Manchester
 Christie Hospital
  Nottingham
 Nottingham City Hospital NHS Trust
  Surrey
 Royal Marsden - Surrey
  Taunton
 Musgrove Park Hospital
  Wirral
 Clatterbridge Centre for Oncology NHS Foundation Trust
Scotland
  Glasgow
 Beatson Cancer Centre, Glasgow

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01578655
ClinicalTrials.gov processed this data on April 13, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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