Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer
NCT ID: NCT01578655
Last Updated: 2016-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
630 participants
INTERVENTIONAL
2012-08-31
2016-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cabazitaxel plus Custirsen
cabazitaxel, prednisone, and custirsen sodium
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
prednisone
Prednisone (10 mg PO) is administered daily until disease progression, unacceptable toxicity, or completion of 10 cycles
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
Cabazitaxel
cabazitaxel and prednisone
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
prednisone
Prednisone (10 mg PO) is administered daily until disease progression, unacceptable toxicity, or completion of 10 cycles
Interventions
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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
prednisone
Prednisone (10 mg PO) is administered daily until disease progression, unacceptable toxicity, or completion of 10 cycles
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
MALE
No
Sponsors
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Achieve Life Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Thomasz Beer, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health & Science University, Portland, Oregon
Karim Fazazi, MD
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy Cancer Institute, University of Paris, France
Sebastien Hotte, MD
Role: PRINCIPAL_INVESTIGATOR
Juravinski Cancer Centre, Hamilton, Ontario, Canada
Locations
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Prostate Oncology Specialists
Marina del Rey, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Sharp Health Care
San Diego, California, United States
California Pacific Medical Center Research Institute
San Francisco, California, United States
Rocky Mountain Cancer Center
Boulder, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Smilow Cancer Hospital at Yale New Haven Hospital
New Haven, Connecticut, United States
The Center for Hematology-Oncology
Boca Raton, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Cancer Specialists
Inverness, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Georgia Cancer Specialists, P.C.
Marietta, Georgia, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Boston University Medical Center
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Urology Cancer Center and GU Research Network
Omaha, Nebraska, United States
Monter Cancer Center
Lake Success, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Albert Einstein Medical Center
The Bronx, New York, United States
Blumenthal Cancer Center
Charlotte, North Carolina, United States
Cancer Centers of North Carolina
Raleigh, North Carolina, United States
Oncology Hematology Care, Inc.
Blue Ash, Ohio, United States
The Mark H. Zangmeister Center
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
South Carolina Oncology Associates
Columbia, South Carolina, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Chattanooga Oncology and Hematology Associates
Chattanooga, Tennessee, United States
The West Clinic
Memphis, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Texas Oncology, PA
Dallas, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
The Canberra Hospital
Garran, Australian Capital Territory, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
St George Public Hospital
Kogarah, New South Wales, Australia
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Haematology and Oncology Clinics of Australia
Brisbane, Queensland, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Epworth Healthcare
Richmond, Victoria, Australia
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Health Sciences Center
London, Ontario, Canada
R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health Oshawa
Oshawa, Ontario, Canada
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
CHUM-Hospital Notre-Dame
Montreal, Quebec, Canada
Krajská nemocnice Liberec a.s.
Liberec, Liberec, Czechia
Krajská nemo. T.Bati, a. s.
Zlín, Severomoravsky Kraj, Czechia
Fakultni nemo Hradec Králové
Hradec Králové, , Czechia
University Hospital Olomouc
Olomouc, , Czechia
Centre Léon Bérard
Lyon Cédex 08, Auvergne-Rhône-Alpes, France
Centre François Baclesse
Caen, Basse-Normandie, France
Institut Jean-Godinot
Reims, Champagne-Ardenne, France
Institut Paoli Calmettes
Marseille, Marseille, France
Institut de Cancérologie de l'Ouest - René Gauducheau
Saint-Herblain, Pays de la Loire Region, France
Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie
Poitiers, Poitou-Charentes, France
Centre Antoine Lacassagne
Nice, Provence-Alpes-Côte d'Azur Region, France
Hôpital Saint Louis
Paris, Île-de-France Region, France
Institut Curie
Paris, Île-de-France Region, France
Institut Gustave Roussy
Villejuif, Île-de-France Region, France
Pándy Kálmán Megyei Kórház
Gyula, Bekes County, Hungary
Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház
Miskolc, Borsod-Abauj Zemplen county, Hungary
Országos Onkológiai Intézet
Budapest, Budapest, Hungary
Semmelweis Egyetem Általános Orvostudományi Kar
Budapest, Budapest, Hungary
Szegedi Tudományegyetem, Onkoterápiás Klinika
Szeged, Csongrád megye, Hungary
Ivanovo Reg Oncology Centre
Ivanovo, Ivanovo Oblast, Russia
Cancer Research Center na NN Blokhin
Moscow, Moscow, Russia
Hertzen Rsrch Inst of Oncology
Moscow, Moscow, Russia
Sverdlovsk Reg Clin Hosp#1
Yekaterinburg, Ural, Russia
Volgograd Regional Oncological Dispensary
Volzhsky, Volgograd Oblast, Russia
S Inst Hlth Altay Reg Onc Disp
Barnaul, , Russia
Russian Research Center of Radiology
Moscow, , Russia
Urology Research Institute
Moscow, , Russia
State Healthcare Inst Omsk Reg
Omsk, , Russia
Petrov Research Oncology Institute
Saint Petersburg, , Russia
Saint Petersburg City Oncological Dispensary
Saint Petersburg, , Russia
Stavropol Reg Oncology Ctr
Stavropol, , Russia
Cancer Research UK
Birmingham, England, United Kingdom
Addenbrookes Hospital Cambridge
Cambridge, England, United Kingdom
U of Surrey Post Grad Med
Guildford, England, United Kingdom
Christie Hospital NHS Foundation Trust
Manchester, England, United Kingdom
Clatterbridge Centre for Oncology NHS Foundation Trust
Metropolitan Borough of Wirral, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
The Royal Marsden Hospital
Surrey, England, United Kingdom
Musgrove Park Hospital
Taunton, England, United Kingdom
Beatson Cancer Centre, Glasgow
Glasgow, Scotland, United Kingdom
Countries
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References
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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.
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.
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.
Other Identifiers
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OGX-011-12
Identifier Type: -
Identifier Source: org_study_id
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