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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - Placebo
Treatment: Drugs - Dasatinib
Treatment: Drugs - Docetaxel
Treatment: Drugs - Prednisone

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


Treatment: Drugs: Placebo


Treatment: Drugs: Dasatinib


Treatment: Drugs: Docetaxel


Treatment: Drugs: Prednisone
Intervention code [1] 0 0
Treatment: Drugs
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
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United States of America
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Alaska
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Arkansas
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California
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Connecticut
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Georgia
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Illinois
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Indiana
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Kansas
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Maine
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Bahia
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Gauteng
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Spain
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Barcelona
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Gijon
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Valencia
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Sundsvall
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Uppsala
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Vaxjo
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Glamorgan
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Middlesex
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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/ct2/show/NCT00744497
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