Trial · NCT00744497
Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-resistant Prostate Cancer
NCT00744497, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2014-02-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-resistant Prostate Cancer. Trials, record NCT00744497. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00744497
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-resistant Prostate Cancer
- NCT number
- NCT00744497
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,930 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Prostatic Neoplasms
- Interventions
- Placebo, Dasatinib, Docetaxel, Prednisone
- First posted
- 2008-09-01
- Last updated
- 2016-10-17
- Other registries' IDs
- eudract:2008-000701-11
- Results first posted
- 2014-02-06
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival: Time From Randomization to Date of Death | From randomization to death or date of last contact (maximum reached: 45 months) | 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 | Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST) | 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) | 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. |
| Secondary | Time to First Skeletal-related Event (SRE) | 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) | 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. |
| Secondary | Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline | 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) | 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. |
| Secondary | Progression-free Survival (PFS) | 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) | 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. |
| Secondary | Time to Prostate Specific Antigen (PSA) Progression | 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) | 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. |
| Secondary | Percentage of Participants With a Reduction in Pain Intensity From Baseline | 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) | 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 | Number of Participants With Serious Adverse Event (SAEs), Drug-related SAEs, Drug-related AEs, Drug-related AEs Leading to Discontinuation, and All Deaths | 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 | 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 |
| Other | Number of Participants With Drug-Related Adverse Events (AEs) of Special Interest | 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 | 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. |
| Other | Number of Participants With Abnormalities in Results of Clinical Laboratory Tests in Hematology | 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. | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival: Time From Randomization to Date of Death | From randomization to death or date of last contact (maximum reached: 45 months) | All participants who were randomized to receive any treatment | Months | MEDIAN |
| SECONDARY | Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST) | 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) | Participants with at least 1 target lesion at baseline | Percentage of participants | NUMBER |
| SECONDARY | Time to First Skeletal-related Event (SRE) | 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) | All participants who were randomized to receive any treatment | Months | MEDIAN |
| SECONDARY | Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline | 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) | Participants who entered the study with baseline urinary N-telopeptide values higher than the upper limit of normal (ULN), or ≥60 nmol/mmol creatinine, if ULN was missing | Percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | 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) | All participants who were randomized to receive any treatment | Months | MEDIAN |
| SECONDARY | Time to Prostate Specific Antigen (PSA) Progression | 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) | All participants who were randomized to receive any treatment | Months | MEDIAN |
| SECONDARY | Percentage of Participants With a Reduction in Pain Intensity From Baseline | 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) | Participants with a baseline pain intensity of 2 or greater | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious Adverse Event (SAEs), Drug-related SAEs, Drug-related AEs, Drug-related AEs Leading to Discontinuation, and All Deaths | 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 | All participants who received treatment | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Drug-Related Adverse Events (AEs) of Special Interest | 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 | All participants who received treatment | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Abnormalities in Results of Clinical Laboratory Tests in Hematology | 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. | All participants who received treatment | Participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group154
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival: Time From Randomization to Date of Death | Placebo | 21.2 | 95% Confidence Interval 20.0 to 23.4 | Months | |
| Overall Survival: Time From Randomization to Date of Death | Dasatinib | 21.5 | 95% Confidence Interval 20.3 to 22.8 | Months | |
| Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST) | Placebo | 31.85 | 95% Confidence Interval 27.21 to 36.78 | Percentage of participants | |
| Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST) | Dasatinib | 30.45 | 95% Confidence Interval 25.86 to 35.34 | Percentage of participants | |
| Time to First Skeletal-related Event (SRE) | Placebo | 31.1 | 95% Confidence Interval 28.8 to NA | Months | |
| Time to First Skeletal-related Event (SRE) | Dasatinib | NA | 95% Confidence Interval NA to NA | Months | |
| Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline | Placebo | 60.60 | 95% Confidence Interval 55.14 to 65.86 | Percentage of participants | |
| Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline | Dasatinib | 66.04 | 95% Confidence Interval 60.58 to 71.21 | Percentage of participants | |
| Progression-free Survival (PFS) | Placebo | 11.1 | 95% Confidence Interval 10.8 to 11.7 | Months | |
| Progression-free Survival (PFS) | Dasatinib | 11.8 | 95% Confidence Interval 11.1 to 13.4 | Months |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 760 | |
| Overall Study | STARTED | Dasatinib | 762 | |
| Overall Study | Received Treatment | Placebo | 757 | |
| Overall Study | Received Treatment | Dasatinib | 761 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | COMPLETED | Dasatinib | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 760 | |
| Overall Study | NOT COMPLETED | Dasatinib | 762 |
Source ClinicalTrials.gov
Adverse events854
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 59 | 757 | |
| other | Dyspepsia | Gastrointestinal disorders | Dasatinib | 50 | 761 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Placebo | 127 | 757 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Dasatinib | 154 | 761 | |
| other | Lacrimation increased | Eye disorders | Placebo | 86 | 757 | |
| other | Lacrimation increased | Eye disorders | Dasatinib | 48 | 761 | |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | Placebo | 42 | 757 | |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | Dasatinib | 15 | 761 | |
| other | Nail disorder | Skin and subcutaneous tissue disorders | Placebo | 119 | 757 | |
| other | Nail disorder | Skin and subcutaneous tissue disorders | Dasatinib | 80 | 761 |
1 to 10 of 854Source ClinicalTrials.gov
See all 854 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Dasatinib | ||
| Total, other adverse events | Placebo | 701 | 757 |
| Total, other adverse events | Dasatinib | 716 | 761 |
| Total, serious adverse events | Placebo | 317 | 757 |
| Total, serious adverse events | Dasatinib | 381 | 761 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dasatinib vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00744497
GET https://conductscience.org/api/trials/v1/NCT00744497/results?page=2