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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
cabazitaxel
prednisone
custirsen sodium
Sponsored by
Achieve Life Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring custirsen sodium, prostate cancer, metastatic castrate resistant prostate cancer, overall survival

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Prostate Oncology Specialists
  • University of California Davis Medical Center
  • Sharp Health Care
  • California Pacific Medical Center Research Institute
  • Rocky Mountain Cancer Center
  • Hartford Hospital
  • Smilow Cancer Hospital at Yale New Haven Hospital
  • The Center for Hematology-Oncology
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • H. Lee Moffitt Cancer Center and Research Institute
  • Georgia Cancer Specialists, P.C.
  • Cancer Center of Kansas
  • Boston University Medical Center
  • University of Michigan Health System
  • Karmanos Cancer Institute
  • Washington University School of Medicine
  • Urology Cancer Center and GU Research Network
  • Albert Einstein Medical Center
  • Monter Cancer Center
  • SUNY Upstate Medical University
  • Blumenthal Cancer Center
  • Cancer Centers of North Carolina
  • Oncology Hematology Care, Inc.
  • The Mark H. Zangmeister Center
  • Oregon Health and Science University
  • South Carolina Oncology Associates
  • Cancer Centers of the Carolinas
  • Chattanooga Oncology and Hematology Associates
  • The West Clinic
  • Tennessee Oncology, PLLC
  • Texas Oncology, PA
  • Utah Cancer Specialists
  • Virginia Oncology Associates
  • Virginia Cancer Institute
  • The Canberra Hospital
  • Royal Prince Alfred Hospital
  • St George Public Hospital
  • Royal North Shore Hospital
  • Westmead Hospital
  • Haematology and Oncology Clinics of Australia
  • The Queen Elizabeth Hospital
  • Royal Hobart Hospital
  • Box Hill Hospital
  • Austin Health
  • Epworth Healthcare
  • Cross Cancer Institute
  • British Columbia Cancer Agency
  • Juravinski Cancer Centre
  • London Health Sciences Center
  • R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health Oshawa
  • The Ottawa Hospital Regional Cancer Centre
  • Sunnybrook Health Sciences Centre
  • CHUM-Hospital Notre-Dame
  • Krajská nemo. T.Bati, a. s.
  • Fakultni nemo Hradec Králové
  • Krajská nemocnice Liberec a.s.
  • University Hospital Olomouc
  • Centre François Baclesse
  • Institut Jean-Godinot
  • Hôpital Saint Louis
  • Institut Curie
  • Institut Gustave Roussy
  • Institut de Cancérologie de l'Ouest - René Gauducheau
  • Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie
  • Centre Antoine Lacassagne
  • Centre Léon Bérard
  • Institut Paoli Calmettes
  • Pándy Kálmán Megyei Kórház
  • Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház
  • Szegedi Tudományegyetem, Onkoterápiás Klinika
  • Országos Onkológiai Intézet
  • Semmelweis Egyetem Általános Orvostudományi Kar
  • Sverdlovsk Reg Clin Hosp#1
  • Volgograd Regional Oncological Dispensary
  • S Inst Hlth Altay Reg Onc Disp
  • Ivanovo Reg Oncology Centre
  • Cancer Research Center na NN Blokhin
  • Hertzen Rsrch Inst of Oncology
  • Russian Research Center of Radiology
  • Urology Research Institute
  • State Healthcare Inst Omsk Reg
  • Petrov Research Oncology Institute
  • Saint Petersburg City Oncological Dispensary
  • Stavropol Reg Oncology Ctr
  • Cancer Research UK
  • Addenbrookes Hospital Cambridge
  • U of Surrey Post Grad Med
  • Christie Hospital NHS Foundation Trust
  • Nottingham City Hospital NHS Trust
  • The Royal Marsden Hospital
  • Musgrove Park Hospital
  • Clatterbridge Centre for Oncology NHS Foundation Trust
  • Beatson Cancer Centre, Glasgow

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cabazitaxel plus Custirsen

Cabazitaxel

Arm Description

cabazitaxel, prednisone, and custirsen sodium

cabazitaxel and prednisone

Outcomes

Primary Outcome Measures

Survival in the intent-to-treat population
To determine whether the survival for patients randomized to the investigational arm (cabazitaxel/prednisone plus custirsen) is consistent with longer survival as compared to patients randomized to the control arm (cabazitaxel/prednisone).
Survival in the poor-prognosis patient population
To determine whether the survival for patients randomized to the investigational arm (cabazitaxel/prednisone plus custirsen) and identified as having poor prognosis is consistent with longer survival as compared to patients randomized to the control arm (cabazitaxel/prednisone) and identified as having poor prognosis.

Secondary Outcome Measures

Progression-free survival at Day 140
To compare the arms with respect to the proportion of patients having a milestone Day 140 status of Alive Without Event (within the window of Day 125-155 post-randomization). An event is defined as disease progression or death on or before Day 140.

Full Information

First Posted
April 9, 2012
Last Updated
October 11, 2016
Sponsor
Achieve Life Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01578655
Brief Title
Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer
Acronym
AFFINITY
Official Title
A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination With Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men With Metastatic Castrate Resistant Prostate Cancer (AFFINITY)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Achieve Life Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
custirsen sodium, prostate cancer, metastatic castrate resistant prostate cancer, overall survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
630 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cabazitaxel plus Custirsen
Arm Type
Experimental
Arm Description
cabazitaxel, prednisone, and custirsen sodium
Arm Title
Cabazitaxel
Arm Type
Active Comparator
Arm Description
cabazitaxel and prednisone
Intervention Type
Drug
Intervention Name(s)
cabazitaxel
Intervention Description
Cabazitaxel (25mg/m² IV) is administered on day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or completion of 10 cycles
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
Prednisone (10 mg PO) is administered daily until disease progression, unacceptable toxicity, or completion of 10 cycles
Intervention Type
Drug
Intervention Name(s)
custirsen sodium
Other Intervention Name(s)
OGX-011, TV-1011
Intervention Description
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
Primary Outcome Measure Information:
Title
Survival in the intent-to-treat population
Description
To determine whether the survival for patients randomized to the investigational arm (cabazitaxel/prednisone plus custirsen) is consistent with longer survival as compared to patients randomized to the control arm (cabazitaxel/prednisone).
Time Frame
3.4 years
Title
Survival in the poor-prognosis patient population
Description
To determine whether the survival for patients randomized to the investigational arm (cabazitaxel/prednisone plus custirsen) and identified as having poor prognosis is consistent with longer survival as compared to patients randomized to the control arm (cabazitaxel/prednisone) and identified as having poor prognosis.
Time Frame
2.7 years
Secondary Outcome Measure Information:
Title
Progression-free survival at Day 140
Description
To compare the arms with respect to the proportion of patients having a milestone Day 140 status of Alive Without Event (within the window of Day 125-155 post-randomization). An event is defined as disease progression or death on or before Day 140.
Time Frame
From randomization to Day 125 to Day 155

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomasz Beer, MD
Organizational Affiliation
Oregon Health & Science University, Portland, Oregon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karim Fazazi, MD
Organizational Affiliation
Gustave Roussy Cancer Institute, University of Paris, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sebastien Hotte, MD
Organizational Affiliation
Juravinski Cancer Centre, Hamilton, Ontario, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prostate Oncology Specialists
City
Marina Del Rey
State/Province
California
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
Country
United States
Facility Name
Sharp Health Care
City
San Diego
State/Province
California
Country
United States
Facility Name
California Pacific Medical Center Research Institute
City
San Francisco
State/Province
California
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Boulder
State/Province
Colorado
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
Smilow Cancer Hospital at Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
The Center for Hematology-Oncology
City
Boca Raton
State/Province
Florida
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
Country
United States
Facility Name
Florida Cancer Specialists
City
Inverness
State/Province
Florida
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Georgia Cancer Specialists, P.C.
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Urology Cancer Center and GU Research Network
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Albert Einstein Medical Center
City
Bronx
State/Province
New York
Country
United States
Facility Name
Monter Cancer Center
City
Lake Success
State/Province
New York
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
Country
United States
Facility Name
Blumenthal Cancer Center
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Cancer Centers of North Carolina
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Blue Ash
State/Province
Ohio
Country
United States
Facility Name
The Mark H. Zangmeister Center
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
Country
United States
Facility Name
South Carolina Oncology Associates
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Chattanooga Oncology and Hematology Associates
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
The West Clinic
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Texas Oncology, PA
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
Country
Australia
Facility Name
St George Public Hospital
City
Kogarah
State/Province
New South Wales
Country
Australia
Facility Name
Royal North Shore Hospital
City
Saint Leonards
State/Province
New South Wales
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
Haematology and Oncology Clinics of Australia
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Woodville South
State/Province
South Australia
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
Epworth Healthcare
City
Richmond
State/Province
Victoria
Country
Australia
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
British Columbia Cancer Agency
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
London Health Sciences Center
City
London
State/Province
Ontario
Country
Canada
Facility Name
R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health Oshawa
City
Oshawa
State/Province
Ontario
Country
Canada
Facility Name
The Ottawa Hospital Regional Cancer Centre
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
CHUM-Hospital Notre-Dame
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
Krajská nemo. T.Bati, a. s.
City
Zlín
State/Province
Severomoravsky Kraj
Country
Czech Republic
Facility Name
Fakultni nemo Hradec Králové
City
Hradec Králové
Country
Czech Republic
Facility Name
Krajská nemocnice Liberec a.s.
City
Liberec
Country
Czech Republic
Facility Name
University Hospital Olomouc
City
Olomouc
Country
Czech Republic
Facility Name
Centre François Baclesse
City
Caen cedex 05
State/Province
Basse-Normandie
Country
France
Facility Name
Institut Jean-Godinot
City
Reims
State/Province
Champagne-Ardenne
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
State/Province
Ile de France
Country
France
Facility Name
Institut Curie
City
Paris Cedex 05
State/Province
Ile-de-France
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
State/Province
Ile-de-France
Country
France
Facility Name
Institut de Cancérologie de l'Ouest - René Gauducheau
City
Saint Herblain
State/Province
Pays de la Loire
Country
France
Facility Name
Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie
City
Poitiers Cedex
State/Province
Poitou-Charentes
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice Cedex 2
State/Province
Provence Alpes Cote d'Azur
Country
France
Facility Name
Centre Léon Bérard
City
Lyon cédex 08
State/Province
Rhone-Alpes
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
Country
France
Facility Name
Pándy Kálmán Megyei Kórház
City
Gyula
State/Province
Bekes
Country
Hungary
Facility Name
Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház
City
Miskolc
State/Province
Borsod-Abauj-Zemplen
Country
Hungary
Facility Name
Szegedi Tudományegyetem, Onkoterápiás Klinika
City
Szeged
State/Province
Csongrad
Country
Hungary
Facility Name
Országos Onkológiai Intézet
City
Budapest
Country
Hungary
Facility Name
Semmelweis Egyetem Általános Orvostudományi Kar
City
Budapest
Country
Hungary
Facility Name
Sverdlovsk Reg Clin Hosp#1
City
Ekaterinburg
State/Province
Ural
Country
Russian Federation
Facility Name
Volgograd Regional Oncological Dispensary
City
Volzhskiy
State/Province
Volgograd
Country
Russian Federation
Facility Name
S Inst Hlth Altay Reg Onc Disp
City
Barnaul
Country
Russian Federation
Facility Name
Ivanovo Reg Oncology Centre
City
Ivanovo
Country
Russian Federation
Facility Name
Cancer Research Center na NN Blokhin
City
Moscow
Country
Russian Federation
Facility Name
Hertzen Rsrch Inst of Oncology
City
Moscow
Country
Russian Federation
Facility Name
Russian Research Center of Radiology
City
Moscow
Country
Russian Federation
Facility Name
Urology Research Institute
City
Moscow
Country
Russian Federation
Facility Name
State Healthcare Inst Omsk Reg
City
Omsk
Country
Russian Federation
Facility Name
Petrov Research Oncology Institute
City
Saint Petersburg
Country
Russian Federation
Facility Name
Saint Petersburg City Oncological Dispensary
City
Saint Petersburg
Country
Russian Federation
Facility Name
Stavropol Reg Oncology Ctr
City
Stavropol
Country
Russian Federation
Facility Name
Cancer Research UK
City
Birmingham
State/Province
England
Country
United Kingdom
Facility Name
Addenbrookes Hospital Cambridge
City
Cambridge
State/Province
England
Country
United Kingdom
Facility Name
U of Surrey Post Grad Med
City
Guildford
State/Province
England
Country
United Kingdom
Facility Name
Christie Hospital NHS Foundation Trust
City
Manchester
State/Province
England
Country
United Kingdom
Facility Name
Nottingham City Hospital NHS Trust
City
Nottingham
State/Province
England
Country
United Kingdom
Facility Name
The Royal Marsden Hospital
City
Surrey
State/Province
England
Country
United Kingdom
Facility Name
Musgrove Park Hospital
City
Taunton
State/Province
England
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology NHS Foundation Trust
City
Wirral
State/Province
England
Country
United Kingdom
Facility Name
Beatson Cancer Centre, Glasgow
City
Glasgow
State/Province
Scotland
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21788353
Citation
Saad F, Hotte S, North S, Eigl B, Chi K, Czaykowski P, Wood L, Pollak M, Berry S, Lattouf JB, Mukherjee SD, Gleave M, Winquist E; Canadian Uro-Oncology Group. Randomized phase II trial of Custirsen (OGX-011) in combination with docetaxel or mitoxantrone as second-line therapy in patients with metastatic castrate-resistant prostate cancer progressing after first-line docetaxel: CUOG trial P-06c. Clin Cancer Res. 2011 Sep 1;17(17):5765-73. doi: 10.1158/1078-0432.CCR-11-0859. Epub 2011 Jul 25.
Results Reference
background
PubMed Identifier
20733135
Citation
Chi KN, Hotte SJ, Yu EY, Tu D, Eigl BJ, Tannock I, Saad F, North S, Powers J, Gleave ME, Eisenhauer EA. Randomized phase II study of docetaxel and prednisone with or without OGX-011 in patients with metastatic castration-resistant prostate cancer. J Clin Oncol. 2010 Sep 20;28(27):4247-54. doi: 10.1200/JCO.2009.26.8771. Epub 2010 Aug 23.
Results Reference
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PubMed Identifier
29033099
Citation
Beer TM, Hotte SJ, Saad F, Alekseev B, Matveev V, Flechon A, Gravis G, Joly F, Chi KN, Malik Z, Blumenstein B, Stewart PS, Jacobs CA, Fizazi K. Custirsen (OGX-011) combined with cabazitaxel and prednisone versus cabazitaxel and prednisone alone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel (AFFINITY): a randomised, open-label, international, phase 3 trial. Lancet Oncol. 2017 Nov;18(11):1532-1542. doi: 10.1016/S1470-2045(17)30605-8. Epub 2017 Oct 9.
Results Reference
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Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer

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