Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-resistant Prostate Cancer
NCT ID: NCT00744497
Last Updated: 2016-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1930 participants
INTERVENTIONAL
2008-10-31
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m\^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
Placebo
Docetaxel
Prednisone
Dasatinib
Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m\^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
Dasatinib
Docetaxel
Prednisone
Interventions
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Placebo
Dasatinib
Docetaxel
Prednisone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Evidence of metastatic disease by any 1 of the following: computed tomography scan, magnetic resonance imaging, bone scan, or skeletal survey
* Evidence of progression, as defined by 1 of the following: rising prostate specific antigen levels at least 1 week apart with the final value being \>=2 ng/mL; progression of measurable nodal or visceral disease, with nodal lesions \>=20 mm and visceral lesions measurable per response evaluation criteria for solid tumors (Response Evaluation in Solid Tumors, version 1); 2 or more lesions appearing on bone scan compared with previous scan; or local recurrence in the prostate or prostate bed
* Maintaining castrate status: Participants who have not undergone surgical orchiectomy should have received and continue on medical therapies, such as gonadotropin releasing hormone analogs, to maintain castrate levels of serum testosterone \<=50 ng/dL
* Eastern Cooperative Oncology Group Performance Status of 0 to 2
* At least 4 weeks since an investigational agent prior to starting study therapy
* At least 8 weeks since radioisotope therapy prior to starting study therapy
* Recovery from any local therapy including surgery or radiation/radiotherapy for a minimum of 7 days prior to starting study therapy
* Required initial laboratory values: white blood cell count \>=3,000/mm\^3; absolute neutrophil count \>=1,500/mm\^3; platelet count \>=100,000/mm\^3; creatinine level \<=1.5\*upper limit of normal (ULN); bilirubin \<=ULN; aspartate aminotransferase \<=2.5\*ULN; alanine aminotransferase \<=2.5\*ULN.
Exclusion Criteria
* Clinically significant cardiovascular disease, including myocardial infarction; ventricular tachyarrhythmia within 6 months; prolonged QTc \>450 msec; ejection fraction \<40%; or major conduction abnormality, unless a cardiac pacemaker is present
* Pleural or pericardial effusion of any Common Terminology Criteria (CTC) grade
* Peripheral neuropathy CTC Grade \>=2
* Currently active second malignancy other than nonmelanoma skin cancers. Participants are not considered to have a currently active malignancy if they have completed therapy and are now considered (by their physician) to be at less than 30% risk for relapse
* Uncontrolled intercurrent illness including ongoing or active infection, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* HIV infection-positive patients receiving combination antiretroviral therapy
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the investigational agents
* Receipt of any other investigational agents for the treatment of prostate cancer
* Prior cytotoxic chemotherapy in the metastatic setting, with the exception of estramustine
* Patients may continue on a daily multivitamin but must discontinue all other herbal, alternative, and food supplements before enrollment
* Ketoconazole must be discontinued 4 weeks prior to starting study therapy
* Antiandrogens must be discontinued prior to starting study therapy. Patients with a history of response to an antiandrogen and subsequent progression while on that antiandrogen should be assessed for antiandrogen withdrawal response for 4 weeks. Observation for antiandrogen withdrawal response is not necessary for those who have never responded to antiandrogens
* Bisphosphonates must not be initiated within 28 days prior to starting study therapy
* QT prolonging agents strongly associated with torsade de pointes.
18 Years
MALE
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University Of South Alabama / Mitchell Cancer Institute
Mobile, Alabama, United States
Southern Cancer Center
Mobile, Alabama, United States
Alaska Clinical Research Center, Llc
Anchorage, Alaska, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
Compassionate Cancer Care Medical Group, Inc.
Corona, California, United States
Desert Hematology Oncology Medical Group
Rancho Mirage, California, United States
Compassionate Cancer Care Medical Group Inc
Riverside, California, United States
Sharp Clinical Oncology Research
San Diego, California, United States
Va San Diego Healthcare System
San Diego, California, United States
Edward Alexson, Md, Inc.
Santa Ana, California, United States
Connecticut Oncology Group
Middletown, Connecticut, United States
Va Connecticut Healthcare System
West Haven, Connecticut, United States
Gwinnett Hospital System Inc.
Lawrenceville, Georgia, United States
University Of Chicago
Chicago, Illinois, United States
Midwestern Regional Medical Center
Zion, Illinois, United States
Fort Wayne Medical Oncology And Hematology Inc
Fort Wayne, Indiana, United States
Cancer Center Of Kansas
Wichita, Kansas, United States
Maine Center For Cancer Medicine
Scarborough, Maine, United States
Tufts Medical Center
Boston, Massachusetts, United States
Jackson Oncology Associates, Pllc
Jackson, Mississippi, United States
North Mississippi Hematology And Oncology Associates, Ltd
Tupelo, Mississippi, United States
New York Oncology Hematology, Pc
Albany, New York, United States
New York Oncology Hematology, Pc
Albany, New York, United States
Samuel S. Stratton Vamc
Albany, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Piedmont Hematology Oncology Associates, Pllc
Winston-Salem, North Carolina, United States
Summa Health System
Akron, Ohio, United States
Mid Ohio Oncology/Hematology, Inc,Dba
Columbus, Ohio, United States
Providence Portland Med Ctr
Portland, Oregon, United States
Regional Hemetology Oncology, Pc
Langhorne, Pennsylvania, United States
Upmc Cancer Pavilion
Pittsburgh, Pennsylvania, United States
Va Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States
Associates In Hematology & Oncology, P.C.
Upland, Pennsylvania, United States
The Miriam Hospital
Providence, Rhode Island, United States
Cancer Centers Of The Carolinas
Greenville, South Carolina, United States
Boston Baskin Cancer Foundation
Memphis, Tennessee, United States
Cancer Specialists Of South Texas, Pa
Corpus Christi, Texas, United States
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States
Providence Regional Cancer System
Lacey, Washington, United States
University Of Washington
Seattle, Washington, United States
Dean Hematology And Oncology Clinic
Madison, Wisconsin, United States
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Buenos Aires, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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La Plata, Buenos Aires, Argentina
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Ramos Mejía, Buenos Aires, Argentina
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Cipolletti, Río Negro Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Cordaba, , Argentina
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Coffs Harbour, New South Wales, Australia
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Lismore, New South Wales, Australia
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Port Macquarie, New South Wales, Australia
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Sydney, New South Wales, Australia
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Douglas, Queensland, Australia
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Milton, Queensland, Australia
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Kurralta Park, South Australia, Australia
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Hobart, Tasmania, Australia
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Frankston, Victoria, Australia
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Ringwood, Victoria, Australia
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Fremantle, Western Australia, Australia
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Salvador, Estado de Bahia, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Barretos, São Paulo, Brazil
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Campinas, São Paulo, Brazil
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Jaú, São Paulo, Brazil
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Santo André, São Paulo, Brazil
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Edmonton, Alberta, Canada
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Abbottsford, British Columbia, Canada
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Moncton, New Brunswick, Canada
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Greater Sudbury, Ontario, Canada
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Ottawa, Ontario, Canada
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Owen Sound, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Rimouski, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Regina, Saskatchewan, Canada
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Saskatoon, Saskatchewan, Canada
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Brno, , Czechia
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Hradec Králové, , Czechia
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Prague, , Czechia
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Turku, , Finland
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Vaasa, , Finland
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Avignon, , France
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Caen, , France
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Paris, , France
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Strasbourg, , France
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Aachen, , Germany
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Berlin, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Kirchheim, , Germany
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Markkleeberg, , Germany
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Athens, , Greece
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Budapest, , Hungary
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Kecskemét, , Hungary
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Zalaegerszeg, , Hungary
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Trivandrum, Kerala, India
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Mumbai, Maharashtra, India
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Pune, Maharashtra, India
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Ahmedabad, , India
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Jaipur, , India
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Kolkata, , India
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Kolkata, , India
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Cork, Cork, Ireland
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Dublin, Dublin, Ireland
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Tallaght, Dublin, Ireland
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Arezzo, , Italy
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Genova, , Italy
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Lecce, , Italy
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Milan, , Italy
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Napoli, , Italy
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Perugia, , Italy
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Roma, , Italy
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Tijuana, Estado de Baja California, Mexico
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Guadalajara, Jalisco, Mexico
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Zapopan, Jalisco, Mexico
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Df, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Tlalpan, Mexico City, Mexico
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Tlalpan, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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México, Querétaro, Mexico
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Huixquilucan, State of Mexico, Mexico
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Toluca, State of Mexico, Mexico
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Stavanger, , Norway
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Lima, Lima Province, Peru
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Lima, Lima Province, Peru
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Lima, Lima Province, Peru
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Lima, Lima Province, Peru
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Lima, Lima Province, Peru
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Callao, Provincia Constitucional del Callao, Peru
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Bialystok, , Poland
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Lodz, , Poland
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Warsaw, , Poland
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Baia Mare, , Romania
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Cluj-Napoca, , Romania
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Timisoara, Timis, , Romania
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Bloemfontein, Free State, South Africa
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Pretoria, Gauteng, South Africa
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Saxonwold, Gauteng, South Africa
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Gijón, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Santander, , Spain
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Seville, , Spain
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Valencia, , Spain
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Kungälv, , Sweden
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Sundsvall, , Sweden
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Uppsala, , Sweden
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Vaxjo, , Sweden
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Essex, Essex, United Kingdom
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Cardiff, Glamorgan, United Kingdom
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London, Middlesex, United Kingdom
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Sutton, Surrey, United Kingdom
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Leeds, West Yorkshire, United Kingdom
Countries
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References
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de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.
Araujo JC, Trudel GC, Saad F, Armstrong AJ, Yu EY, Bellmunt J, Wilding G, McCaffrey J, Serrano SV, Matveev VB, Efstathiou E, Oudard S, Morris MJ, Sizer B, Goebell PJ, Heidenreich A, de Bono JS, Begbie S, Hong JH, Richardet E, Gallardo E, Paliwal P, Durham S, Cheng S, Logothetis CJ. Docetaxel and dasatinib or placebo in men with metastatic castration-resistant prostate cancer (READY): a randomised, double-blind phase 3 trial. Lancet Oncol. 2013 Dec;14(13):1307-16. doi: 10.1016/S1470-2045(13)70479-0. Epub 2013 Nov 8.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2008-000701-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA180-227
Identifier Type: -
Identifier Source: org_study_id
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