Clinical trial · Interventional
Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer
NCT00385580CI-TRIAL-00010162completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to learn if men with metastatic prostate cancer and rising Prostate Specific Antigen (PSA), who have been surgically castrated or are undergoing androgen deprivation with Luteinizing Hormone Releasing Hormone (LHRH) treatment, respond to dasatinib. The safety of this treatment will also be studied.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dasatinib | Drug | Dasatinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: dasatinib
- type
- EXPERIMENTAL
- label
- 2
- interventionNames
- Drug: dasatinib
Primary outcomes (2)
- measure
- Number of Participants With a Response
- timeFrame
- Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.
- description
- 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 \[RECIST\].
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * males, 18 or older * proven advanced prostate cancer * documented metastatic disease * rising PSA levels * castrate levels of testosterone Exclusion Criteria: * symptomatic CNS (brain or spinal cord) metastasis * medical condition which may increase the risk of toxicity * any prior or ongoing anti-cancer medical therapy or immunotherapy for prostate cancer other than primary androgen deprivation agents * unable to take oral medication
References
Publications (1)
- BACKGROUNDYu EY, Wilding G, Posadas E, Gross M, Culine S, Massard C, Morris MJ, Hudes G, Calabro F, Cheng S, Trudel GC, Paliwal P, Sternberg CN. Phase II study of dasatinib in patients with metastatic castration-resistant prostate cancer. Clin Cancer Res. 2009 Dec 1;15(23):7421-8. doi: 10.1158/1078-0432.CCR-09-1691. Epub 2009 Nov 17. PMID 19920114