Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: September 25, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to determine whether survival can be prolonged in patients with castration-resistant prostate cancer who receive dasatinib with docetaxel and prednisone.


Condition Intervention Phase
Prostatic Neoplasms
Drug: Placebo
Drug: Dasatinib
Drug: Docetaxel
Drug: 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:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall Survival: Time From Randomization to Date of Death [ Time Frame: From randomization to death or date of last contact (maximum reached: 45 months) ] [ Designated as safety issue: No ]
    Overall survival is defined as time in months from the randomization date to the date of death due to any cause (in the randomized population). If the patient did not die, survival was censored on the last date he or she was known to be alive.


Secondary Outcome Measures:
  • Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: At baseline and every 12 weeks thereafter to end of treatment, at end of treatment, and at follow-up (within 42 days of end of dosing) ] [ Designated as safety issue: No ]
    Objective tumor response rate=the percentage of randomized participants with a best tumor response of partial (PR) or complete response (CR), within 42 days of end of dosing, divided by total number of patients who were evaluable (with at least 1 target lesion at baseline). By RECIST: CR=disappearance of clinical and radiologic evidence of target and nontarget lesions confirmed by another evaluation at least 6 weeks later. PR=a >30% or greater decrease in the sum of longest diameter (LD) of target lesions in reference to the baseline sum LD confirmed by another evaluation at least 6 weeks later. Stable disease=neither sufficient increase to qualify for PD nor shrinkage to qualify for PR, and at least 8 weeks since start of study therapy. Progressive disease=a 20% or greater increase in sum of LD of all target lesions, taking as reference the smallest sum of LD at or following baseline, or unequivocal progression on existing nontarget lesions, or new lesions are present.

  • Time to First Skeletal-related Event (SRE) [ Time Frame: From day of randomization to date of first SRE or to last SRE assessment, if subsequent cancer therapy begun or no SRE (maximum reached: 42 months) ] [ Designated as safety issue: No ]
    Time to first SRE is defined as the time in months from the date of randomization to the date of first SRE (unless SRE occurred while the patient was undergoing subsequent cancer therapy). Participants with a first SRE while on subsequent cancer therapy, those who died without a reported SRE, and those who did not have an SRE were censored on the date of their last SRE assessment prior to start of subsequent cancer therapy, if any. Participants who had no SRE assessments were censored on the day they were randomized.

  • Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline [ Time Frame: At baseline, prior to each docetaxel infusion (every 3 weeks) to end of treatment, at end of treatment, and at follow-up (within 14 days of end of dosing) ] [ Designated as safety issue: No ]
    The percentage of participants who had an on-study uNTx value confirmed (at least 3 weeks later) within normal limits (or ≥3 and <60 nmol/mmol creatinine, if normal limits were missing) or an on-study uNTx level reduction from baseline of ≥35%, even when on-study uNTx value remained abnormal.

  • Progression-free Survival (PFS) [ Time Frame: From day of randomization to disease progression or death (or to last clinical assessment, if subsequent cancer therapy started or no progression or death) (maximum reached: approximately 43 months) ] [ Designated as safety issue: No ]
    PFS is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Those who progressed or died while on subsequent cancer therapy and those who did not die or progress were censored at their last radiologic bone scan/imaging, skeletal related-event, or tumor assessment or at measurement of prostate specific antigen levels, whichever occurred last prior to start of subsequent cancer therapy ,if any. Participants with no assessments were censored on the day of randomization.

  • Time to Prostate Specific Antigen (PSA) Progression [ Time Frame: From randomization to date of first PSA measurement leading to confirmed PSA progression (or to last bone scan assessment, if no progression or if cancer therapy started) (maximum reached: 30 months) ] [ Designated as safety issue: No ]
    PSA progression is defined as the time from randomization to the date of the first PSA level measurement that led to confirmed PSA progression, for participants who had not started subsequent cancer therapy. For participants who did not progress or who progressed on cancer therapy, PSA progression is defined as the time from randomization to the date of the last PSA level measurement before the start of cancer therapy, if any. Participants who had no on-study PSA level measurements were censored on the day they were randomized.

  • Percentage of Participants With a Reduction in Pain Intensity From Baseline [ Time Frame: At baseline, prior to each docetaxel infusion (every 3 weeks), at end of treatment, and at follow-up (within 14 days of end of dosing) ] [ Designated as safety issue: No ]
    The percentage of participants with a reduction in pain intensity from baseline was defined as the number of participants who achieved a 30% or more decrease in pain intensity from baseline for at least 2 consecutive pain assessments (at least 14 days apart) within 14 days of end of dosing divided by the number of randomized participants who had a baseline pain intensity of at least 2. Pain intensity was assessed based on question 3 of the brief pain inventory questionnaire.


Other Outcome Measures:
  • Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation [ Time Frame: Continuously throughout study to >=30 days after last dose of study drug until resolution of drug-related toxicity, or when toxicity was deemed irreversible, whichever shorter. ] [ Designated as safety issue: Yes ]
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug

  • Number of Participants With Adverse Events (AEs) of Special Interest [ Time Frame: Continuously throughout study to >=30 days after last dose of study drug until resolution of drug-related toxicity, or when toxicity was deemed irreversible, whichever was shorter ] [ Designated as safety issue: Yes ]
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. AEs of Special Interest=recognized events in other agents within this drug class or events for which safety data from nonclinical and clinical studies with dasatinib indicate that careful evaluation is warranted. AEs of Special Interest are identified by the medical and safety representatives of the sponsor based on MedDRA preferred terms or laboratory data. ANC=absolute neutrophil count.

  • Number of Participants With Abnormalities in Results of Clinical Laboratory Tests in Hematology [ Time Frame: At baseline, within 3 days prior to each infusion of docetaxel (each cycle) and at end of treatment. If docetaxel is discontinued, every other cycle. ] [ Designated as safety issue: Yes ]
    Abnormalities were graded according to the Common Toxicity Criteria (CTC), version 3.0, of the National Cancer Institute. CTC are graded from 1 (least severe) to 4 (life threatening ). Grade 3 and 4 criteria are defined as follows: Absolute neutrophil count, Grade 3, neutrophils <1.0-0.5*10^9/L; Grade 4, <0.5*10^9/L. Hemoglobin, Grade 3, <4.9-4.0 mmol/L; Grade 4, <4.0 mmol/L. Platelets, Grade 3, <50.0-25.0*10^9/L; Grade 4, <25.0*10^9/L. Leukocytes, Grade 3, <2.0-1.0*10^9/L; Grade 4, <1.0*10^9/L.

  • Number of Participants With Abnormalities in Results of Clinical Laboratory Tests Assessing Liver Function, Renal Function, and Electrolytes [ Time Frame: At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle. ] [ Designated as safety issue: Yes ]
    ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal. Abnormalities were graded according to the Common Toxicity Criteria (CTC), version 3.0, of the National Cancer Institute. CTC are graded from 1 (least severe) to 4 (life threatening). ALP, ALT, and AST, Grade 3, >5.0-20.0*ULN; Grade 4, >20.0*ULN. Total bilirubin, Grade 3, >3.0-10.0*ULN; Grade 4, >10.0*ULN. Creatinine, Grade 3, >3.0-6.0*ULN; Grade 4, >6.0*ULN. Hypercalcemia(serum calcium, mmol/L), Grade 3, >3.1-3.4; Grade 4, >3.4. Hypocalcemia (serum calcium, mmol/L), Grade 3, <1.75-1.5; Grade 4, <1.5. Hyperkalemia(serum calcium, mmol/L), Grade 3, >6.0-7.0; Grade 4, >7.0. Hypokalemia(serum calcium, mmol/L), Grade 3, <3.0-2.5; Grade 4, <2.5. Hypernatremia (serum calcium, mmol/L), Grade 3, >155-160; Grade 4, >160. Hyponatremia (serum sodium, mmol/L), Grade 3, <130-120; Grade 4, <120. Phosphorus (serum sodium, mmol/L), Grade 3, <0.6-0.3; Grade 4, <0.3.

  • Number of Participants With Abnormal Results in Urinalysis [ Time Frame: At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle. ] [ Designated as safety issue: Yes ]
    Abnormal=positive, defined as the presence of >=30 mg/dL of protein; a small, moderate, or large amount of blood; or >0 g/dL glucose in urine. BL=baseline; neg=negative

  • Number of Participants by Maximal On-study Fridericia-corrected QTc Interval by Electrocardiogram [ Time Frame: At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing ] [ Designated as safety issue: Yes ]
  • Number of Participants With Changes From Baseline in Fridericia-corrected QTc Interval by Electrocardiogram [ Time Frame: At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing ] [ Designated as safety issue: Yes ]
  • Number of Participants With and Without Pericardial Effusion at Baseline and On-study and With Left Ventricular Ejection Fraction (LVEF) <40% and >=40%On-study by Echocardiogram [ Time Frame: At baseline, approximately 12 weeks after start of treatment, and thereafter whenever clinically indicated ] [ Designated as safety issue: Yes ]
    BL=baseline; OS=on-study


Enrollment: 1930
Study Start Date: October 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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
Drug: Placebo Drug: Docetaxel Drug: Prednisone
Active Comparator: 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
Drug: Dasatinib
Other Names:
  • Sprycel
  • BMS-354825
Drug: Docetaxel Drug: Prednisone

  Eligibility

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

Inclusion Criteria:

  • History of histologically diagnosed prostate cancer
  • 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:

  • Symptomatic brain metastases or leptomeningeal metastases
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Llc
Anchorage, Alaska, United States, 99508
United States, Arkansas
Highlands Oncology Group
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
Va San Diego Healthcare System
San Diego, California, United States, 92161
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
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
Gwinnett Hospital System Inc.
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
New York Oncology Hematology, Pc
Albany, New York, United States, 12206
New York Oncology Hematology, Pc
Albany, New York, United States, 12208
Samuel S. Stratton Vamc
Albany, New York, United States, 12208
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, Pllc
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 Hemetology Oncology, Pc
Langhorne, Pennsylvania, United States, 19047
Upmc Cancer Pavilion
Pittsburgh, Pennsylvania, United States, 15232
Va Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
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, 29615
United States, Tennessee
Boston Baskin Cancer Foundation
Memphis, Tennessee, United States, 38120
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, 1426
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Capital Federal, Buenos Aires, Argentina, 1425
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Capital Federal, Buenos Aires, Argentina, C1405BCJ
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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, S2000CVD
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Rosario, Santa Fe, Argentina, S2000DSK
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San Miguel De Tucuman, Tucuman, Argentina, T4000IAK
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Buenos Aires, Argentina, C1280AEB
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Buenos Aires, Argentina, C1426ANZ
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Buenos Aires, Argentina, C1181ACH
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Cordaba, 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
Brazil
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Salvador, Bahia, Brazil, 41950
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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, 22551
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Rio De Janeiro, Brazil, 20230
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, Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
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Montreal, Quebec, Canada, H2W 1Y5
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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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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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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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Kirchheim, Germany, 73230
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Markkleeberg, Germany, 04416
Greece
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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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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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Ahmedabad, India, 380009
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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, 135-710
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Seoul, Korea, Republic of, 138-736
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Seoul, Korea, Republic of, 135-720
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Seoul, Korea, Republic of, 120-752
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, 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
Local Institution
Stavanger, Norway, 4068
Peru
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Callao, Peru, CALLAO 2
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Lima, Peru, 34
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Lima, Peru, LIMA 11
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Lima, Peru, 41
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Lima, Peru, 11
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Lima, Peru, LIMA 29
Poland
Local Institution
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
Local Institution
Moscow, Russian Federation, 115478
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Moscow, Russian Federation, 117997
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St Petersburg, Russian Federation, 197758
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St Petersburg, Russian Federation, 197022
South Africa
Local Institution
Bloemfontein, Free State, South Africa, 9301
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Pretoria, Gauteng, South Africa, 0181
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Saxonwold, Gauteng, South Africa, 2199
Spain
Local Institution
Barcelona, Spain, 08208
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Barcelona, Spain, 08025
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Barcelona, Spain, 08003
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Gijon, Spain, 33394
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Madrid, Spain, 28050
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Madrid, Spain, 28033
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Madrid, Spain, 28007
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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
Local Institution
Cardiff, Glamorgan, United Kingdom, CF14 2TL
Local Institution
London, Middlesex, United Kingdom, W12 0NN
Local Institution
Sutton, Surrey, United Kingdom, SM2 5PT
Local Institution
Leeds, West Yorkshire, United Kingdom, LS8 7TF
Local Institution
Essex, United Kingdom, CO3 3NB
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: November 15, 2013
Last Updated: September 25, 2014
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:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Dasatinib
Docetaxel
Prednisone
Anti-Inflammatory Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014