Trial · NCT00385580
Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer
NCT00385580, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2011-03-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer. Trials, record NCT00385580. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00385580
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer
- NCT number
- NCT00385580
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 94 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Prostate Cancer
- Interventions
- dasatinib, dasatinib
- First posted
- 2006-10-09
- Last updated
- 2013-04-30
- Results first posted
- 2011-03-01
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Response | Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks. | Response = confirmed prostate specific antigen (PSA) response (decrease in PSA =\>50% from baseline), confirmed improved bone scan (disappearance of =\> 1 lesion, no new lesions, new pain not developing), confirmed complete response (CR: disappearance of all lesions) or confirmed partial response (PR: =\>30% in sum of longest diameter \[LD\] of all lesions compared to baseline sum LD), stable disease (SD: neither sufficient increase for progressive disease \[PD: =\>20% increase in sum of LD of all target lesions\] nor sufficient shrinkage for PR), based on Response Criteria in Solid Tumors \[RECIST\]. |
| Primary | Percentage of Participants With a Response | Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks. | Response = confirmed PSA response (decrease in PSA =\>50% from baseline), confirmed improved bone scan (disappearance of =\> 1 lesion, no new lesions, new pain not developing), confirmed CR (disappearance of all lesions) or confirmed PR (=\>30% in sum of LD of all lesions compared to baseline sum LD), SD (neither sufficient increase for PD \[=\>20% increase in sum of LD of all target lesions\] nor sufficient shrinkage for PR), based on RECIST. |
| Secondary | Number of Participants With a Decrease in PSA by at Least 50% From Baseline | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | PSA is a marker of prostate cancer and a PSA response is defined as a decrease in the PSA value by at least 50% from baseline, for 2 successive evaluations, each at least 2 weeks apart, for a total of 3 measurements. |
| Secondary | Percentage of Participants With a Decrease in PSA by at Least 50% From Baseline | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | PSA is a marker of prostate cancer and a PSA response is defined as a decrease in the PSA value by at least 50% from baseline for 2 successive evaluations, each at least 2 weeks apart, for a total of 3 measurements. |
| Secondary | Number of Months of Decrease in PSA by at Least 50% From Baseline | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | PSA is a marker of prostate cancer. The duration of PSA response is measured from the time that the first of the 2 consecutive measurements met the criteria for confirmed PSA response, until the date of the first of the 3 consecutive measurements that confirm PSA progression, or the date of disease progression, or the date of death. |
| Secondary | Number of Participants With Decrease in PSA Velocity | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | PSA is a marker of prostate cancer. PSA velocity measures the rate of change of PSA values. A decrease in PSA values and hence PSA velocity is an early indicator of potential anti-tumor activity. |
| Secondary | Number of Participants With Decrease in PSA Log Slope | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | PSA is a marker of prostate cancer. A decrease in PSA value is an early indicator of potential anti-tumor activity. Log (PSA) is assumed to have a linear relationship with time. The PSA log slope is defined as the slope of the log PSA line. |
| Secondary | Number of Participants With Increase in PSA Doubling Time | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | PSA is a marker of prostate cancer. PSA doubling time is defined as log 2 divided by the slope of the log PSA line. An increase in PSA doubling time indicates improvement in anti-tumor activity. |
| Secondary | Number of Participants With CR or PR | Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment. | Tumor response was defined as the number of participants whose best response was CR or PR, per RECIST: CR: disappearance of all target/non-target lesions; PR: \>= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD |
| Secondary | Number of Participants With CR, PR or SD | Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment. | Disease control rate is defined as the number of participants whose best response was CR, PR or SD, per RECIST: CR: disappearance of all target/non-target lesions; PR: \>= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD; SD: neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR; PD: defined as appearance of new lesion/s, or \>=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions. |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Response | Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks. | All treated participants. | participants | NUMBER |
| PRIMARY | Percentage of Participants With a Response | Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks. | All treated participants. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With a Decrease in PSA by at Least 50% From Baseline | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | All PSA response-evaluable participants: participants who had pre-treatment PSA measurements and at least 2 on-study PSA measurements. | participants | NUMBER |
| SECONDARY | Percentage of Participants With a Decrease in PSA by at Least 50% From Baseline | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | All PSA response-evaluable participants: participants who had pre-treatment PSA measurements and at least 2 on-study PSA measurements. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Months of Decrease in PSA by at Least 50% From Baseline | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | Participants with a decrease in PSA by at least 50% from baseline | months | NUMBER |
| SECONDARY | Number of Participants With Decrease in PSA Velocity | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements. | participants | NUMBER |
| SECONDARY | Number of Participants With Decrease in PSA Log Slope | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements. | participants | NUMBER |
| SECONDARY | Number of Participants With Increase in PSA Doubling Time | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | All PSA response-evaluable participants: participants who had 2 or more pre-treatment PSA measurements and at least 2 on-study PSA measurements and positive log slope pre-treatment and on-study measurements. | participants | NUMBER |
| SECONDARY | Number of Participants With CR or PR | Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment. | All response-evaluable participants. | participants | NUMBER |
| SECONDARY | Number of Participants With CR, PR or SD | Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment. | All response-evaluable participants. | participants | NUMBER |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group249
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Response | Dasatinib 100 mg Once Daily (QD) | 12 | participants | ||
| Number of Participants With a Response | Dasatinib 100 mg or 70 mg Twice Daily (BID) | 13 | participants | ||
| Percentage of Participants With a Response | Dasatinib 100 mg Once Daily (QD) | 25.00 | 95% Confidence Interval 13.64 to 39.60 | Percentage of Participants | |
| Percentage of Participants With a Response | Dasatinib 100 mg or 70 mg Twice Daily (BID) | 27.70 | 95% Confidence Interval 15.62 to 42.64 | Percentage of Participants | |
| Number of Participants With a Decrease in PSA by at Least 50% From Baseline | Dasatinib 100 mg Once Daily (QD) | 1 | participants | ||
| Number of Participants With a Decrease in PSA by at Least 50% From Baseline | Dasatinib 100 mg or 70 mg Twice Daily (BID) | 1 | participants | ||
| Percentage of Participants With a Decrease in PSA by at Least 50% From Baseline | Dasatinib 100 mg Once Daily (QD) | 2.3 | Percentage of Participants | ||
| Percentage of Participants With a Decrease in PSA by at Least 50% From Baseline | Dasatinib 100 mg or 70 mg Twice Daily (BID) | 2.3 | Percentage of Participants | ||
| Number of Months of Decrease in PSA by at Least 50% From Baseline | Dasatinib 100 mg Once Daily (QD) | 0.82 | months | ||
| Number of Months of Decrease in PSA by at Least 50% From Baseline | Dasatinib 100 mg or 70 mg Twice Daily (BID) | 11.17 | months |
1 to 10 of 249Source ClinicalTrials.gov
See all 249 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib 100 mg Once Daily (QD) | 48 | |
| Overall Study | STARTED | Dasatinib 100 mg or 70 mg Twice Daily (BID) | 47 | |
| Overall Study | COMPLETED | Dasatinib 100 mg Once Daily (QD) | 48 | |
| Overall Study | COMPLETED | Dasatinib 100 mg or 70 mg Twice Daily (BID) | 47 | |
| Overall Study | NOT COMPLETED | Dasatinib 100 mg Once Daily (QD) | 0 | |
| Overall Study | NOT COMPLETED | Dasatinib 100 mg or 70 mg Twice Daily (BID) | 0 |
Source ClinicalTrials.gov
Adverse events86
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 | WEIGHT DECREASED | Investigations | Dasatinib | 13 | 95 | |
| other | WEIGHT INCREASED | Investigations | Dasatinib | 7 | 95 | |
| other | ELECTROCARDIOGRAM QT PROLONGED | Investigations | Dasatinib | 13 | 95 | |
| other | ATRIAL FIBRILLATION | Cardiac disorders | Dasatinib | 6 | 95 | |
| other | PERICARDIAL EFFUSION | Cardiac disorders | Dasatinib | 12 | 95 | |
| other | FLUSHING | Vascular disorders | Dasatinib | 10 | 95 | |
| other | HOT FLUSH | Vascular disorders | Dasatinib | 6 | 95 | |
| other | DEPRESSION | Psychiatric disorders | Dasatinib | 7 | 95 | |
| other | HEADACHE | Nervous system disorders | Dasatinib | 32 | 95 | |
| other | DIZZINESS | Nervous system disorders | Dasatinib | 12 | 95 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib | ||
| Total, other adverse events | Dasatinib | 94 | 95 |
| Total, serious adverse events | Dasatinib | 21 | 95 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19920114 | BACKGROUND |
Source PubMed
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 comparisons13
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dasatinib 100 mg Once Daily (QD) vs Dasatinib 100 mg or 70 mg Twice Daily (BID): Number of Participants With Disease Progression | Trial comparisons |
| Dasatinib 100 mg Once Daily (QD) vs Dasatinib 100 mg or 70 mg Twice Daily (BID): Number of Participants With CR or PR | Trial comparisons |
| Dasatinib 100 mg Once Daily (QD) vs Dasatinib 100 mg or 70 mg Twice Daily (BID): Number of Participants With Abnormal Lactate Dehydrogenase (LD) | Trial comparisons |
| Dasatinib 100 mg Once Daily (QD) vs Dasatinib 100 mg or 70 mg Twice Daily (BID): Number of Participants With Decrease in PSA Velocity | Trial comparisons |
| Dasatinib 100 mg Once Daily (QD) vs Dasatinib 100 mg or 70 mg Twice Daily (BID): Number of Participants With CR, PR or SD | Trial comparisons |
| Dasatinib 100 mg Once Daily (QD) vs Dasatinib 100 mg or 70 mg Twice Daily (BID): Number of Participants With Increase in PSA Doubling Time | Trial comparisons |
| Dasatinib 100 mg Once Daily (QD) vs Dasatinib 100 mg or 70 mg Twice Daily (BID): Number of Participants With BAP Response | Trial comparisons |
| Dasatinib 100 mg Once Daily (QD) vs Dasatinib 100 mg or 70 mg Twice Daily (BID): Number of Participants With Decrease in PSA Log Slope | Trial comparisons |
| Dasatinib 100 mg Once Daily (QD) vs Dasatinib 100 mg or 70 mg Twice Daily (BID): Number of Participants With a Confirmed Improved Bone Scan | Trial comparisons |
| Dasatinib 100 mg Once Daily (QD) vs Dasatinib 100 mg or 70 mg Twice Daily (BID): Number of Participants With QTc Prolongation | Trial comparisons |
1 to 10 of 13
See all 13 trial comparisonsTests0
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.
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The record and each of its lists are JSON, twenty rows a page. No key.
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