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

Primary Purpose

Prostatic Neoplasms

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

Dasatinib

Docetaxel

Prednisone

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Dasatinib

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall Survival: Time From Randomization to Date of Death

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)

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 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

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)

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

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

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.

Full Information

NCT ID

NCT00744497

First Posted

August 29, 2008

Last Updated

August 23, 2016

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00744497

Brief Title

Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-resistant Prostate Cancer

Acronym

READY

Official Title

A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1930 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Dasatinib

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Drug

Intervention Name(s)

Dasatinib

Other Intervention Name(s)

Sprycel, BMS-354825

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Type

Drug

Intervention Name(s)

Prednisone

Primary Outcome Measure Information:

Title

Overall Survival: Time From Randomization to Date of Death

Description

Time Frame

From randomization to death or date of last contact (maximum reached: 45 months)

Secondary Outcome Measure Information:

Title

Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST)

Description

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)

Title

Time to First Skeletal-related Event (SRE)

Description

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)

Title

Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline

Description

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)

Title

Progression-free Survival (PFS)

Description

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)

Title

Time to Prostate Specific Antigen (PSA) Progression

Description

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)

Title

Percentage of Participants With a Reduction in Pain Intensity From Baseline

Description

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)

Other Pre-specified Outcome Measures:

Title

Number of Participants With Serious Adverse Event (SAEs), Drug-related SAEs, Drug-related AEs, Drug-related AEs Leading to Discontinuation, and All Deaths

Description

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

Time Frame

Continuously throughout study to <=30 days after last dose of study drug; included AEs with an onset date >= day 1 and <= last dose date + 30 days

Title

Number of Participants With Drug-Related Adverse Events (AEs) of Special Interest

Description

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. Drug-related=having certain, probable, possible, or missing relationship to study drug. Drug-related 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.

Time Frame

Continuously throughout study to <=30 days after last dose of study drug; included AEs with an onset date >= day 1 and <= last dose date + 30 days

Title

Number of Participants With Abnormalities in Results of Clinical Laboratory Tests in Hematology

Description

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.

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.

Title

Number of Participants With Abnormalities in Results of Clinical Laboratory Tests Assessing Liver Function, Renal Function, and Electrolytes

Description

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.

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.

Title

Number of Participants With Abnormal Results in Urinalysis

Description

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

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.

Title

Number of Participants by Maximal On-study Fridericia-corrected QTc Interval

Description

QTc interval measured by electrocardiogram (ECG). Although a participant may have had several ECGs, only the longest QTc interval was included.

Time Frame

At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing

Title

Number of Participants With Changes From Baseline in Fridericia-corrected QTc Interval

Description

QTc interval measured by electrocardiogram (ECG). Although a participant may have had several ECGs, only the longest QTc interval was included.

Time Frame

At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing

Title

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

Description

BL=baseline; OS=on-study

Time Frame

At baseline, approximately 12 weeks after start of treatment, and thereafter whenever clinically indicated

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

University Of South Alabama / Mitchell Cancer Institute

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36604

Country

United States

Facility Name

Southern Cancer Center

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Alaska Clinical Research Center, Llc

City

Anchorage

State/Province

Alaska

ZIP/Postal Code

99508

Country

United States

Facility Name

Highlands Oncology Group

City

Fayetteville

State/Province

Arkansas

ZIP/Postal Code

72703

Country

United States

Facility Name

Compassionate Cancer Care Medical Group, Inc.

City

Corona

State/Province

California

ZIP/Postal Code

92879

Country

United States

Facility Name

Desert Hematology Oncology Medical Group

City

Rancho Mirage

State/Province

California

ZIP/Postal Code

92270

Country

United States

Facility Name

Compassionate Cancer Care Medical Group Inc

City

Riverside

State/Province

California

ZIP/Postal Code

92501

Country

United States

Facility Name

Sharp Clinical Oncology Research

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Va San Diego Healthcare System

City

San Diego

State/Province

California

ZIP/Postal Code

92161

Country

United States

Facility Name

Edward Alexson, Md, Inc.

City

Santa Ana

State/Province

California

ZIP/Postal Code

92705

Country

United States

Facility Name

Connecticut Oncology Group

City

Middletown

State/Province

Connecticut

ZIP/Postal Code

06457

Country

United States

Facility Name

Va Connecticut Healthcare System

City

West Haven

State/Province

Connecticut

ZIP/Postal Code

06516

Country

United States

Facility Name

Gwinnett Hospital System Inc.

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Facility Name

University Of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Midwestern Regional Medical Center

City

Zion

State/Province

Illinois

ZIP/Postal Code

60099

Country

United States

Facility Name

Fort Wayne Medical Oncology And Hematology Inc

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46845

Country

United States

Facility Name

Cancer Center Of Kansas

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Maine Center For Cancer Medicine

City

Scarborough

State/Province

Maine

ZIP/Postal Code

04074

Country

United States

Facility Name

Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Jackson Oncology Associates, Pllc

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39202

Country

United States

Facility Name

North Mississippi Hematology And Oncology Associates, Ltd

City

Tupelo

State/Province

Mississippi

ZIP/Postal Code

38801

Country

United States

Facility Name

New York Oncology Hematology, Pc

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

Facility Name

New York Oncology Hematology, Pc

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

Samuel S. Stratton Vamc

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Piedmont Hematology Oncology Associates, Pllc

City

Winston-salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Summa Health System

City

Akron

State/Province

Ohio

ZIP/Postal Code

44304

Country

United States

Facility Name

Mid Ohio Oncology/Hematology, Inc,Dba

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43219

Country

United States

Facility Name

Providence Portland Med Ctr

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

Regional Hemetology Oncology, Pc

City

Langhorne

State/Province

Pennsylvania

ZIP/Postal Code

19047

Country

United States

Facility Name

Upmc Cancer Pavilion

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

Va Pittsburgh Healthcare System

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15240

Country

United States

Facility Name

Associates In Hematology & Oncology, P.C.

City

Upland

State/Province

Pennsylvania

ZIP/Postal Code

19013

Country

United States

Facility Name

The Miriam Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

Facility Name

Cancer Centers Of The Carolinas

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Facility Name

Boston Baskin Cancer Foundation

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Facility Name

Cancer Specialists Of South Texas, Pa

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78412

Country

United States

Facility Name

The University Of Texas Md Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Providence Regional Cancer System

City

Lacey

State/Province

Washington

ZIP/Postal Code

98503

Country

United States

Facility Name

University Of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Dean Hematology And Oncology Clinic

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53717

Country

United States

Facility Name

Local Institution

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

1417

Country

Argentina

Facility Name

Local Institution

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

1425

Country

Argentina

Facility Name

Local Institution

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

1426

Country

Argentina

Facility Name

Local Institution

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

C1405BCJ

Country

Argentina

Facility Name

Local Institution

City

La Plata

State/Province

Buenos Aires

ZIP/Postal Code

1900

Country

Argentina

Facility Name

Local Institution

City

Ramos Mejia

State/Province

Buenos Aires

ZIP/Postal Code

1234

Country

Argentina

Facility Name

Local Institution

City

Cipolletti

State/Province

Rio Negro

ZIP/Postal Code

R8324BEH

Country

Argentina

Facility Name

Local Institution

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000CVD

Country

Argentina

Facility Name

Local Institution

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DSK

Country

Argentina

Facility Name

Local Institution

City

San Miguel De Tucuman

State/Province

Tucuman

ZIP/Postal Code

T4000IAK

Country

Argentina

Facility Name

Local Institution

City

Buenos Aires

ZIP/Postal Code

C1181ACH

Country

Argentina

Facility Name

Local Institution

City

Buenos Aires

ZIP/Postal Code

C1280AEB

Country

Argentina

Facility Name

Local Institution

City

Buenos Aires

ZIP/Postal Code

C1426ANZ

Country

Argentina

Facility Name

Local Institution

City

Cordaba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Local Institution

City

Coffs Harbour

State/Province

New South Wales

ZIP/Postal Code

2450

Country

Australia

Facility Name

Local Institution

City

Lismore

State/Province

New South Wales

ZIP/Postal Code

2480

Country

Australia

Facility Name

Local Institution

City

Port Macquarie

State/Province

New South Wales

ZIP/Postal Code

2444

Country

Australia

Facility Name

Local Institution

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2076

Country

Australia

Facility Name

Local Institution

City

Douglas

State/Province

Queensland

ZIP/Postal Code

4814

Country

Australia

Facility Name

Local Institution

City

Milton

State/Province

Queensland

ZIP/Postal Code

4164

Country

Australia

Facility Name

Local Institution

City

Kurralta Park

State/Province

South Australia

ZIP/Postal Code

5037

Country

Australia

Facility Name

Local Institution

City

Hobart

State/Province

Tasmania

ZIP/Postal Code

7000

Country

Australia

Facility Name

Local Institution

City

Frankston

State/Province

Victoria

ZIP/Postal Code

3199

Country

Australia

Facility Name

Local Institution

City

Ringwood

State/Province

Victoria

ZIP/Postal Code

3135

Country

Australia

Facility Name

Local Institution

City

Fremantle

State/Province

Western Australia

ZIP/Postal Code

6162

Country

Australia

Facility Name

Local Institution

City

Salvador

State/Province

Bahia

ZIP/Postal Code

41950

Country

Brazil

Facility Name

Local Institution

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90610

Country

Brazil

Facility Name

Local Institution

City

Barretos

State/Province

Sao Paulo

ZIP/Postal Code

14784

Country

Brazil

Facility Name

Local Institution

City

Campinas

State/Province

Sao Paulo

ZIP/Postal Code

13083

Country

Brazil

Facility Name

Local Institution

City

Jau

State/Province

Sao Paulo

ZIP/Postal Code

17210

Country

Brazil

Facility Name

Local Institution

City

Santo Andre

State/Province

Sao Paulo

ZIP/Postal Code

09060

Country

Brazil

Facility Name

Local Institution

City

Rio De Janeiro

ZIP/Postal Code

20230

Country

Brazil

Facility Name

Local Institution

City

Rio De Janeiro

ZIP/Postal Code

22551

Country

Brazil

Facility Name

Local Institution

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Local Institution

City

Abbottsford

State/Province

British Columbia

ZIP/Postal Code

V2S 3N5

Country

Canada

Facility Name

Local Institution

City

Moncton

State/Province

New Brunswick

ZIP/Postal Code

E1C 6Z8

Country

Canada

Facility Name

Local Institution

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Local Institution

City

Owen Sound

State/Province

Ontario

ZIP/Postal Code

N4K 2J1

Country

Canada

Facility Name

Local Institution

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3E 5J1

Country

Canada

Facility Name

Local Institution

City

Thunder Bay

State/Province

Ontario

ZIP/Postal Code

P7B 6V4

Country

Canada

Facility Name

Local Institution

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2H1

Country

Canada

Facility Name

Local Institution

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1S6

Country

Canada

Facility Name

Local Institution

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1Y5

Country

Canada

Facility Name

Local Institution

City

Rimouski

State/Province

Quebec

ZIP/Postal Code

G5L 5T1

Country

Canada

Facility Name

Local Institution

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Local Institution

City

Regina

State/Province

Saskatchewan

ZIP/Postal Code

S4T 7T1

Country

Canada

Facility Name

Local Institution

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 4H4

Country

Canada

Facility Name

Local Institution

City

Brno

ZIP/Postal Code

656 53

Country

Czech Republic

Facility Name

Local Institution

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czech Republic

Facility Name

Local Institution

City

Praha 2

ZIP/Postal Code

128 08

Country

Czech Republic

Facility Name

Local Institution

City

Praha 8

ZIP/Postal Code

180 81

Country

Czech Republic

Facility Name

Local Institution

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

Local Institution

City

Vaasa

ZIP/Postal Code

65130

Country

Finland

Facility Name

Local Institution

City

Avignon

ZIP/Postal Code

84082

Country

France

Facility Name

Local Institution

City

Besancon Cedex

ZIP/Postal Code

25030

Country

France

Facility Name

Local Institution

City

Caen

ZIP/Postal Code

14076

Country

France

Facility Name

Local Institution

City

Creteil

ZIP/Postal Code

94010

Country

France

Facility Name

Local Institution

City

Paris

ZIP/Postal Code

75908

Country

France

Facility Name

Local Institution

City

St Genis Laval

ZIP/Postal Code

69230

Country

France

Facility Name

Local Institution

City

Strasbourg

ZIP/Postal Code

67085

Country

France

Facility Name

Local Institution

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Local Institution

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

Local Institution

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Local Institution

City

Essen

ZIP/Postal Code

45122

Country

Germany

Facility Name

Local Institution

City

Kirchheim

ZIP/Postal Code

73230

Country

Germany

Facility Name

Local Institution

City

Markkleeberg

ZIP/Postal Code

04416

Country

Germany

Facility Name

Local Institution

City

Athens

ZIP/Postal Code

11528

Country

Greece

Facility Name

Local Institution

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Local Institution

City

Kecskemet

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Local Institution

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Local Institution

City

Trivandrum

State/Province

Kerala

ZIP/Postal Code

695011

Country

India

Facility Name

Local Institution

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400026

Country

India

Facility Name

Local Institution

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411001

Country

India

Facility Name

Local Institution

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411004

Country

India

Facility Name

Local Institution

City

Ahmedabad

ZIP/Postal Code

380009

Country

India

Facility Name

Local Institution

City

Jaipur

ZIP/Postal Code

302013

Country

India

Facility Name

Local Institution

City

Kolkata

ZIP/Postal Code

700 053

Country

India

Facility Name

Local Institution

City

Kolkatta

ZIP/Postal Code

700 016

Country

India

Facility Name

Local Institution

City

Dublin 7

State/Province

Dublin

Country

Ireland

Facility Name

Local Institution

City

Tallaght

State/Province

Dublin

ZIP/Postal Code

DUBLIN 24

Country

Ireland

Facility Name

Local Institution

City

Cork

Country

Ireland

Facility Name

Local Institution

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Local Institution

City

Arezzo

ZIP/Postal Code

52100

Country

Italy

Facility Name

Local Institution

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Local Institution

City

Lecce

ZIP/Postal Code

73100

Country

Italy

Facility Name

Local Institution

City

Milan

ZIP/Postal Code

20141

Country

Italy

Facility Name

Local Institution

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Local Institution

City

Perugia

ZIP/Postal Code

06132

Country

Italy

Facility Name

Local Institution

City

Roma

ZIP/Postal Code

00161

Country

Italy

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

135-720

Country

Korea, Republic of

Facility Name

Local Institution

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Local Institution

City

Tijuana

State/Province

Baja California

ZIP/Postal Code

22010

Country

Mexico

Facility Name

Local Institution

City

State/Province

Distrito Federal

ZIP/Postal Code

06720

Country

Mexico

Facility Name

Local Institution

City

Mexico D.f.

State/Province

Distrito Federal

ZIP/Postal Code

14050

Country

Mexico

Facility Name

Local Institution

City

Tlalpan

State/Province

Distrito Federal

ZIP/Postal Code

14000

Country

Mexico

Facility Name

Local Institution

City

Tlalpan

State/Province

Distrito Federal

ZIP/Postal Code

14080

Country

Mexico

Facility Name

Local Institution

City

Huixquilucan

State/Province

Estado De Mexico

ZIP/Postal Code

52763

Country

Mexico

Facility Name

Local Institution

City

Toluca

State/Province

Estado De Mexico

ZIP/Postal Code

50180

Country

Mexico

Facility Name

Local Institution

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44280

Country

Mexico

Facility Name

Local Institution

City

Zapopan

State/Province

Jalisco

ZIP/Postal Code

45150

Country

Mexico

Facility Name

Local Institution

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Local Institution

City

Mexico

State/Province

Queretaro

ZIP/Postal Code

76200

Country

Mexico

Facility Name

Local Institution

City

Stavanger

ZIP/Postal Code

4068

Country

Norway

Facility Name

Local Institution

City

Callao

ZIP/Postal Code

CALLAO 2

Country

Peru

Facility Name

Local Institution

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Local Institution

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Local Institution

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Local Institution

City

Lima

ZIP/Postal Code

LIMA 11

Country

Peru

Facility Name

Local Institution

City

Lima

ZIP/Postal Code

LIMA 29

Country

Peru

Facility Name

Local Institution

City

Bialystok

ZIP/Postal Code

15-027

Country

Poland

Facility Name

Local Institution

City

Lodz

ZIP/Postal Code

93-509

Country

Poland

Facility Name

Local Institution

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Local Institution

City

Baia Mare

ZIP/Postal Code

430031

Country

Romania

Facility Name

Local Institution

City

Cluj Napoca

ZIP/Postal Code

400015

Country

Romania

Facility Name

Local Institution

City

Timisoara, Timis

ZIP/Postal Code

300239

Country

Romania

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Local Institution

City

Moscow

ZIP/Postal Code

117997

Country

Russian Federation

Facility Name

Local Institution

City

St Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Local Institution

City

St Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Local Institution

City

Bloemfontein

State/Province

Free State

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Local Institution

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0181

Country

South Africa

Facility Name

Local Institution

City

Saxonwold

State/Province

Gauteng

ZIP/Postal Code

2199

Country

South Africa

Facility Name

Local Institution

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Local Institution

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Local Institution

City

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Local Institution

City

Gijon

ZIP/Postal Code

33394

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28033

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Local Institution

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

Local Institution

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Local Institution

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

Local Institution

City

Kungalv

ZIP/Postal Code

442 83

Country

Sweden

Facility Name

Local Institution

City

Sundsvall

ZIP/Postal Code

851 86

Country

Sweden

Facility Name

Local Institution

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

Facility Name

Local Institution

City

Vaxjo

ZIP/Postal Code

351 85

Country

Sweden

Facility Name

Local Institution

City

Cardiff

State/Province

Glamorgan

ZIP/Postal Code

CF14 2TL

Country

United Kingdom

Facility Name

Local Institution

City

London

State/Province

Middlesex

ZIP/Postal Code

W12 0NN

Country

United Kingdom

Facility Name

Local Institution

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Facility Name

Local Institution

City

Leeds

State/Province

West Yorkshire

ZIP/Postal Code

LS8 7TF

Country

United Kingdom

Facility Name

Local Institution

City

Essex

ZIP/Postal Code

CO3 3NB

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

24722180

Citation

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.

Results Reference

derived

PubMed Identifier

24211163

Citation

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.

Results Reference

derived

Links:

URL

http://www.bms.com/studyconnect/Pages/home.aspx

Description

BMS clinical trial educational resource

Learn more about this trial

Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-resistant Prostate Cancer

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

Prostatic Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial