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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
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United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Alaska
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Arkansas
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Connecticut
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Georgia
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Indiana
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Mississippi
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North Carolina
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Oregon
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Lima
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Cluj Napoca
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Romania
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Timisoara, Timis
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Russian Federation
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Moscow
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Russian Federation
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St Petersburg
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South Africa
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Free State
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South Africa
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Gauteng
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Spain
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Barcelona
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Gijon
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Madrid
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Santander
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Sevilla
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Spain
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Valencia
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Sweden
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Kungalv
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Sundsvall
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Sweden
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Uppsala
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Sweden
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Vaxjo
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United Kingdom
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Glamorgan
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United Kingdom
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Middlesex
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Surrey
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West Yorkshire
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Essex

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

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00744497
Trial related presentations / publications
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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00744497