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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00744497




Registration number
NCT00744497
Ethics application status
Date submitted
29/08/2008
Date registered
1/09/2008
Date last updated
17/10/2016

Titles & IDs
Public title
Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-resistant Prostate Cancer
Scientific title
A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer
Secondary ID [1] 0 0
2008-000701-11
Secondary ID [2] 0 0
CA180-227
Universal Trial Number (UTN)
Trial acronym
READY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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

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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival: Time From Randomization to Date of Death
Timepoint [1] 0 0
From randomization to death or date of last contact (maximum reached: 45 months)
Secondary outcome [1] 0 0
Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST)
Timepoint [1] 0 0
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)
Secondary outcome [2] 0 0
Time to First Skeletal-related Event (SRE)
Timepoint [2] 0 0
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)
Secondary outcome [3] 0 0
Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
Progression-free Survival (PFS)
Timepoint [4] 0 0
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)
Secondary outcome [5] 0 0
Time to Prostate Specific Antigen (PSA) Progression
Timepoint [5] 0 0
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)
Secondary outcome [6] 0 0
Percentage of Participants With a Reduction in Pain Intensity From Baseline
Timepoint [6] 0 0
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)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2015
Sample size
Target
Accrual to date
Final
1930
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Coffs Harbour
Recruitment hospital [2] 0 0
Local Institution - Lismore
Recruitment hospital [3] 0 0
Local Institution - Port Macquarie
Recruitment hospital [4] 0 0
Local Institution - Sydney
Recruitment hospital [5] 0 0
Local Institution - Douglas
Recruitment hospital [6] 0 0
Local Institution - Milton
Recruitment hospital [7] 0 0
Local Institution - Kurralta Park
Recruitment hospital [8] 0 0
Local Institution - Hobart
Recruitment hospital [9] 0 0
Local Institution - Frankston
Recruitment hospital [10] 0 0
Local Institution - Ringwood
Recruitment hospital [11] 0 0
Local Institution - Fremantle
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2480 - Lismore
Recruitment postcode(s) [3] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [4] 0 0
2076 - Sydney
Recruitment postcode(s) [5] 0 0
4814 - Douglas
Recruitment postcode(s) [6] 0 0
4164 - Milton
Recruitment postcode(s) [7] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [8] 0 0
7000 - Hobart
Recruitment postcode(s) [9] 0 0
3199 - Frankston
Recruitment postcode(s) [10] 0 0
3135 - Ringwood
Recruitment postcode(s) [11] 0 0
6162 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Maine
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Mississippi
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Rhode Island
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Argentina
State/province [24] 0 0
Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Rio Negro
Country [26] 0 0
Argentina
State/province [26] 0 0
Santa Fe
Country [27] 0 0
Argentina
State/province [27] 0 0
Tucuman
Country [28] 0 0
Argentina
State/province [28] 0 0
Cordaba
Country [29] 0 0
Brazil
State/province [29] 0 0
Bahia
Country [30] 0 0
Brazil
State/province [30] 0 0
Rio Grande Do Sul
Country [31] 0 0
Brazil
State/province [31] 0 0
Sao Paulo
Country [32] 0 0
Brazil
State/province [32] 0 0
Rio De Janeiro
Country [33] 0 0
Canada
State/province [33] 0 0
Alberta
Country [34] 0 0
Canada
State/province [34] 0 0
British Columbia
Country [35] 0 0
Canada
State/province [35] 0 0
New Brunswick
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Canada
State/province [37] 0 0
Quebec
Country [38] 0 0
Canada
State/province [38] 0 0
Saskatchewan
Country [39] 0 0
Czech Republic
State/province [39] 0 0
Brno
Country [40] 0 0
Czech Republic
State/province [40] 0 0
Hradec Kralove
Country [41] 0 0
Czech Republic
State/province [41] 0 0
Praha 2
Country [42] 0 0
Czech Republic
State/province [42] 0 0
Praha 8
Country [43] 0 0
Finland
State/province [43] 0 0
Turku
Country [44] 0 0
Finland
State/province [44] 0 0
Vaasa
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France
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Avignon
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France
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Besancon Cedex
Country [47] 0 0
France
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Caen
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France
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Creteil
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France
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Paris
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France
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St Genis Laval
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France
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Strasbourg
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Germany
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Aachen
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Germany
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Berlin
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Germany
State/province [54] 0 0
Erlangen
Country [55] 0 0
Germany
State/province [55] 0 0
Essen
Country [56] 0 0
Germany
State/province [56] 0 0
Kirchheim
Country [57] 0 0
Germany
State/province [57] 0 0
Markkleeberg
Country [58] 0 0
Greece
State/province [58] 0 0
Athens
Country [59] 0 0
Hungary
State/province [59] 0 0
Budapest
Country [60] 0 0
Hungary
State/province [60] 0 0
Kecskemet
Country [61] 0 0
Hungary
State/province [61] 0 0
Zalaegerszeg
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India
State/province [62] 0 0
Kerala
Country [63] 0 0
India
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Maharashtra
Country [64] 0 0
India
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Ahmedabad
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India
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Jaipur
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India
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Kolkata
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India
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Kolkatta
Country [68] 0 0
Ireland
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Dublin
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Ireland
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Cork
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Italy
State/province [70] 0 0
Arezzo
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Italy
State/province [71] 0 0
Genova
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Italy
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Lecce
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Italy
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Milan
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Italy
State/province [74] 0 0
Napoli
Country [75] 0 0
Italy
State/province [75] 0 0
Perugia
Country [76] 0 0
Italy
State/province [76] 0 0
Roma
Country [77] 0 0
Korea, Republic of
State/province [77] 0 0
Seoul
Country [78] 0 0
Mexico
State/province [78] 0 0
Baja California
Country [79] 0 0
Mexico
State/province [79] 0 0
Distrito Federal
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Mexico
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Estado De Mexico
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Mexico
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Jalisco
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Mexico
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Nuevo Leon
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Mexico
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Queretaro
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Norway
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Stavanger
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Peru
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Callao
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Peru
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Lima
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Poland
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Bialystok
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Poland
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Lodz
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Poland
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Warszawa
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Romania
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Baia Mare
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Romania
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Cluj Napoca
Country [92] 0 0
Romania
State/province [92] 0 0
Timisoara, Timis
Country [93] 0 0
Russian Federation
State/province [93] 0 0
Moscow
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Russian Federation
State/province [94] 0 0
St Petersburg
Country [95] 0 0
South Africa
State/province [95] 0 0
Free State
Country [96] 0 0
South Africa
State/province [96] 0 0
Gauteng
Country [97] 0 0
Spain
State/province [97] 0 0
Barcelona
Country [98] 0 0
Spain
State/province [98] 0 0
Gijon
Country [99] 0 0
Spain
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Madrid
Country [100] 0 0
Spain
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Santander
Country [101] 0 0
Spain
State/province [101] 0 0
Sevilla
Country [102] 0 0
Spain
State/province [102] 0 0
Valencia
Country [103] 0 0
Sweden
State/province [103] 0 0
Kungalv
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Sweden
State/province [104] 0 0
Sundsvall
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Sweden
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Uppsala
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Sweden
State/province [106] 0 0
Vaxjo
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Glamorgan
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Middlesex
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Surrey
Country [110] 0 0
United Kingdom
State/province [110] 0 0
West Yorkshire
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Essex

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00744497