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Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-Resistant Prostate Cancer (READY)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00744497
First received: August 29, 2008
Last updated: October 5, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to determine whether survival can be prolonged in patients with castration-resistant prostate cancer who receive Dasatinib in addition to Docetaxel and Prednisone.


Condition Intervention Phase
Prostatic Neoplasms
 Drug: Placebo + Docetaxel/Prednisone
Drug: Dasatinib + Docetaxel/Prednisone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Assessed at each study visit (every 3 weeks while on treatment and every 12 weeks during follow-up) to death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare objective tumor response rate [by modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria] for subjects with measurable disease at baseline [ Time Frame: Every 12 weeks until progression of disease ] [ Designated as safety issue: No ]
  • Compare time to first skeletal -related event [ Time Frame: Every 12 weeks until progression of disease ] [ Designated as safety issue: No ]
  • Compare proportion of subjects with reduction in urinary N-telopeptide from baseline [ Time Frame: Each study visit (every 3 weeks while on treatment and every 12 weeks during follow up) until progression of disease ] [ Designated as safety issue: No ]
  • Compare progression free survival [ Time Frame: Each study visit (every 3 weeks while on treatment and every 12 weeks during follow up) until progression of disease ] [ Designated as safety issue: No ]
  • Compare time to Prostate Specific Antigen (PSA) progression [ Time Frame: Each study visit (every 3 weeks while on treatment and every 12 weeks during follow up) until progression of disease ] [ Designated as safety issue: No ]
  • Compare proportion of subjects with reduction in pain intensity from baseline [ Time Frame: Each study visit (every 3 weeks while on treatment and every 12 weeks during follow up) until progression of disease ] [ Designated as safety issue: No ]
  • Evaluate safety and tolerability of combination Dasatinib/Docetaxel by collection of adverse event information and review of laboratory values at every study visit [ Time Frame: Continuously throughout study (on treatment every 3 weeks and during follow up every 12 weeks) to death ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1500
Study Start Date: October 2008
Estimated Study Completion Date: February 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo + Docetaxel/Prednisone
Tablets, Oral, 0 mg, Once daily, average 18 weeks, depending on response
Active Comparator: 2 Drug: Dasatinib + Docetaxel/Prednisone
Tablets, Oral, 100 mg, Once daily, average 18 weeks, depending on response
Other Names:
  • Sprycel
  • BMS-354825

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically diagnosed prostate cancer
  • Evidence of metastatic disease
  • Evidence of progression, by rising PSA, nodal/visceral disease, bone scan, or local recurrence
  • Serum testosterone ≤ 50 ng/dL
  • Must be able to take oral medications
  • Performance status 0, 1 or 2

Exclusion Criteria:

  • Symptomatic brain or leptomeningeal metastases
  • Clinically significant cardiovascular disease
  • Pleural or pericardial effusion
  • Currently active second malignancy
  • Uncontrolled intercurrent illness
  • Prior cytotoxic chemotherapy, with the exception of estramustine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744497

  Hide Study Locations
Locations
United States, Alabama
University Of South Alabama / Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
Southern Cancer Center
Mobile, Alabama, United States, 36608
United States, Alaska
Alaska Clinical Research Center
Anchorage, Alaska, United States, 99508
United States, Arkansas
Highlands Oncology Group, P.A.
Fayetteville, Arkansas, United States, 72703
United States, California
Compassionate Cancer Care Medical Group, Inc.
Corona, California, United States, 92879
Desert Hematology Oncology Medical Group
Rancho Mirage, California, United States, 92270
Compassionate Cancer Care Medical Group, Inc.
Riverside, California, United States, 92501
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
Va San Diego Healthcare System
San Diego, California, United States, 92161
Edward Alexson, Md, Inc.
Santa Ana, California, United States, 92705
United States, Connecticut
Connecticut Oncology Group
Middletown, Connecticut, United States, 06457
Va Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
United States, Georgia
Suburban Hematology-Oncology Associates, Pc
Lawrenceville, Georgia, United States, 30046
United States, Illinois
University Of Chicago
Chicago, Illinois, United States, 60637
Midwestern Regional Medical Center
Zion, Illinois, United States, 60099
United States, Indiana
Fort Wayne Medical Oncology And Hematology Inc
Fort Wayne, Indiana, United States, 46845
United States, Kansas
Cancer Center Of Kansas
Wichita, Kansas, United States, 67214
United States, Maine
Maine Center For Cancer Medicine
Scarborough, Maine, United States, 04074
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Mississippi
Jackson Oncology Associates, Pllc
Jackson, Mississippi, United States, 39202
North Mississippi Hematology And Oncology Associates, Ltd
Tupelo, Mississippi, United States, 38801
United States, New York
Samuel S. Stratton Dept. Of Vet. Affairs Med. Ctr.
Albany, New York, United States, 12208
New York Oncology Hematology, Pc
Albany, New York, United States, 12208
New York Oncology Hematology, Pc
Albany, New York, United States, 12206
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Piedmont Hematology Oncology Associates, Pa
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Summa Health System
Akron, Ohio, United States, 44304
Mid Ohio Oncology/Hematology, Inc,Dba
Columbus, Ohio, United States, 43219
United States, Oregon
Providence Portland Med Ctr
Portland, Oregon, United States, 97213
United States, Pennsylvania
Regional Hematology Oncology Associates Pc
Langhorne, Pennsylvania, United States, 19047
Va Medical Center Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
Upmc Cancer Pavilion
Pittsburgh, Pennsylvania, United States, 15232
Associates In Hematology & Oncology, P.C.
Upland, Pennsylvania, United States, 19013
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
Cancer Centers Of The Carolinas
Greenville, South Carolina, United States, 29605
United States, Tennessee
University Of Tennessee Cancer Institute
Memphis, Tennessee, United States, 38104
United States, Texas
Cancer Specialists Of South Texas, Pa
Corpus Christi, Texas, United States, 78412
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Providence Regional Cancer System
Lacey, Washington, United States, 98503
University Of Washington
Seattle, Washington, United States, 98109
United States, Wisconsin
Dean Hematology And Oncology Clinic
Madison, Wisconsin, United States, 53717
Argentina
Local Institution
Caba, Buenos Aires, Argentina, 1417
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Capital Federal, Buenos Aires, Argentina, C1405BCJ
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Capital Federal, Buenos Aires, Argentina, 1425
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Capital Federal, Buenos Aires, Argentina, 1426
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La Plata, Buenos Aires, Argentina, 1900
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Ramos Mejia, Buenos Aires, Argentina, 1234
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Cipolletti, Rio Negro, Argentina, R8324BEH
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Rosario, Santa Fe, Argentina, 2000
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Rosario, Santa Fe, Argentina, S2000CVD
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San Miguel De Tucuman, Tucuman, Argentina, CP T4000IA
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Buenos Aires, Argentina, C1181ACH
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Buenos Aires, Argentina, C1280AEB
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Buenos Aires, Argentina, C1426ANZ
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Cordoba, Argentina, 5000
Australia, New South Wales
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Coffs Harbour, New South Wales, Australia, 2450
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Lismore, New South Wales, Australia, 2480
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Port Macquarie, New South Wales, Australia, 2444
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Sydney, New South Wales, Australia, 2076
Australia, Queensland
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Douglas, Queensland, Australia, 4814
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Milton, Queensland, Australia, 4164
Australia, South Australia
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Kurralta Park, South Australia, Australia, 5037
Australia, Tasmania
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Hobart, Tasmania, Australia, 7000
Australia, Victoria
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Frankston, Victoria, Australia, 3199
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Ringwood, Victoria, Australia, 3135
Australia, Western Australia
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Fremantle, Western Australia, Australia, 6162
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Perth, Western Australia, Australia, 6000
Brazil
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Salvador, Bahia, Brazil, 41825
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610
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Barretos, Sao Paulo, Brazil, 14784
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Campinas, Sao Paulo, Brazil, 13083
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Jau, Sao Paulo, Brazil, 17210
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Santo Andre, Sao Paulo, Brazil, 09060
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Rio De Janeiro, Brazil, 20230
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Rio De Janeiro, Brazil, 22551
Canada, Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
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Abbottsford, British Columbia, Canada, V2S 3N5
Canada, New Brunswick
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Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
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Ottawa, Ontario, Canada, K1H 8L6
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Owen Sound, Ontario, Canada, N4K 2J1
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Sudbury, Ontario, Canada, P3E 5J1
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Thunder Bay, Ontario, Canada, P7B 6V4
Canada, Prince Edward Island
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Charlottetown, Prince Edward Island, Canada, C1A 8T5
Canada, Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
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Montreal, Quebec, Canada, H2L 4M1
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Montreal, Quebec, Canada, H2W 1S6
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Rimouski, Quebec, Canada, G5L 5T1
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Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
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Saskatoon, Saskatchewan, Canada, S7N 4H4
Czech Republic
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Brno, Czech Republic, 656 53
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Hradec Kralove, Czech Republic, 500 05
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Praha 2, Czech Republic, 128 08
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Praha 8, Czech Republic, 180 81
Finland
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Lappeenranta, Finland, 53130
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Turku, Finland, 20520
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Vaasa, Finland, 65130
France
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Avignon, France, 84082
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Besancon Cedex, France, 25030
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Caen, France, 14076
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Creteil, France, 94010
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Montpellier, France, 34960
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Paris, France, 75908
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St Genis Laval, France, 69230
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Strasbourg, France, 67085
Germany
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Aachen, Germany, 52074
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Berlin, Germany, 12200
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Erlangen, Germany, 91054
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Essen, Germany, 45122
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Hamburg, Germany, 22607
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Kirchheim, Germany, 73230
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Markkleeberg, Germany, 04416
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Ulm, Germany, 89081
Greece
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Athens, Greece, 15123
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Athens, Greece, 11528
Hungary
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Budapest, Hungary, 1122
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Kecskemet, Hungary, 6000
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Zalaegerszeg, Hungary, 8900
India
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Navrangpura, Ahmedabad, Gujarat, India, 380009
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Trivandrum, Kerala, India, 695011
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Mumbai, Maharashtra, India, 400026
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Pune, Maharashtra, India, 411004
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Pune, Maharashtra, India, 411001
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Coimbatore, India, 641005
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Delhi, India, 110085
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Jaipur, India, 302013
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Kolkata, India, 700 053
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Kolkatta, India, 700 016
Ireland
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Dublin 7, Dublin, Ireland
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Tallaght, Dublin, Ireland, DUBLIN 24
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Cork, Ireland
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Dublin, Ireland, 7
Italy
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Arezzo, Italy, 52100
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Genova, Italy, 16132
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Lecce, Italy, 73100
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Milan, Italy, 20141
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Napoli, Italy, 80131
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Perugia, Italy, 06132
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Roma, Italy, 00161
Korea, Republic of
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Seoul, Korea, Republic of, 120-752
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Seoul, Korea, Republic of, 135-720
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Seoul, Korea, Republic of, 135-710
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Seoul, Korea, Republic of, 138-736
Mexico
Local Institution
Tijuana, Baja California, Mexico, 22010
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Df, Distrito Federal, Mexico, 06720
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Mexico D.F., Distrito Federal, Mexico, 14050
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Tlalpan, Distrito Federal, Mexico, 14000
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Tlalpan, Distrito Federal, Mexico, 14080
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Huixquilucan, Estado De Mexico, Mexico, 52763
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Toluca, Estado De Mexico, Mexico, 50180
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Guadalajara, Jal., Jalisco, Mexico, 44280
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Zapopan, Jalisco, Mexico, 45150
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Monterrey, Nuevo Leon, Mexico, 64460
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Mexico, Queretaro, Mexico, 76200
Norway
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Drammen, Norway, 3004
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Stavanger, Norway, 4068
Peru
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Callao, Peru, CALLAO 2
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Lima, Peru, 11
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Lima, Peru, LIMA 29
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Lima, Peru, LIMA 11
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Lima, Peru, 34
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Lima, Peru, 41
Poland
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Bialystok, Poland, 15-027
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Lodz, Poland, 93-509
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Warszawa, Poland, 02-781
Romania
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Baia Mare, Romania, 430031
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Cluj Napoca, Romania, 400015
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Timisoara, Timis, Romania, 300239
Russian Federation
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Moscow, Russian Federation, 115478
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Moscow, Russian Federation, 117997
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St Petersburg, Russian Federation, 197022
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St Petersburg, Russian Federation, 197758
South Africa
Local Institution
Bloemfontein, Free State, South Africa, 9301
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Johannesburg, Gauteng, South Africa, 2057
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Pretoria, Gauteng, South Africa, 0181
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Saxonwold, Gauteng, South Africa, 2199
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Amanzimtoti, Kwa Zulu Natal, South Africa, 4126
Spain
Local Institution
Barcelona, Spain, 08003
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Barcelona, Spain, 08208
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Barcelona, Spain, 08025
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Gijon, Spain, 33394
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Madrid, Spain, 28033
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Madrid, Spain, 28007
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Madrid, Spain, 28050
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Santander, Spain, 39008
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Sevilla, Spain, 41013
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Valencia, Spain, 46009
Sweden
Local Institution
Kungalv, Sweden, 442 83
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Sundsvall, Sweden, 851 86
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Uppsala, Sweden, 751 85
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Vaxjo, Sweden, 351 85
United Kingdom
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Cardiff, Glamorgan, United Kingdom, CF4 2TL
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London, Middlesex, United Kingdom, W12 0NN
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Sutton, Surrey, United Kingdom, SM2 5PT
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Leeds, West Yorkshire, United Kingdom, LS8 7TF
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Essex, United Kingdom, CO3 3NB
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00744497     History of Changes
Other Study ID Numbers: CA180-227, 2008-000701-11
Study First Received: August 29, 2008
Last Updated: October 5, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: National Committee of Ethics in Research
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Ireland: Irish Medicines Board
Italy: Ministry of Health
Korea: Food and Drug Administration
Mexico: Federal Commission for Sanitary Risks Protection
Norway:National Committee for Medical and Health Research Ethics
Peru: Health National Institute
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: FSI Scientific Center of Expertise of Medical Application
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel
Dasatinib
Glucocorticoids
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013