Entry Detail
| General information | |
| Database: | DB00043 |
| Objective: | Antiproliferative and antiosteoclastic activity from preclinical models show potential for dasatinib, an oral SRC and SRC family kinase inhibitor, as a targeted therapy for patients with prostate cancer. Thisphase II study investigated the activity of dasatinib in patients with metastatic castrationresistant prostate cancer (CRPC). |
| Authors: | Yu EY, et al |
| Title: | Phase II study of dasatinib in patients with metastatic castrationresistant prostate cancer. |
| Journal: | Clin Cancer Res. |
| Year: | 2009 |
| PMID: | 19920114 |
| Trial Design | |
| Clinical Trial Id: | NCT00385580 |
| Agent: | dasatinib |
| Target: | Protooncogene tyrosineprotein kinase SRC Abl Protooncogene tyrosineprotein kinase LCK Protooncogene tyrosineprotein kinase Fyn |
| Cancer Type: | prostate cancer |
| Cancer Subtype: | advanced castrationresistant prostate cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II study |
| Key Patients Feature: | Chemotherapynaive men with CRPC and increasing prostatespecific antigen, of whom 41 (87%) had bone disease |
| Biomarker: | PSA |
| Biomark Analysis: | Serum prostatespecific antigen levels were prospectively monitored as a biomarker for cancer activity. |
| Control Group Info: | single arm |
| Treatment Info: | pts were treated with dasatinib 100 or 70 mg twice daily |
| Primary End Point: | changes in prostatespecific antigen, bone scans, measurable disease, and markers of bone metabolism. |
| Secondary End Point: | NA |
| Patients Number: | 47 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | Lack of progression was achieved in 20 (43%) patients at week 12 and in 9 (19%) patients at week 24. Of 41 evaluable patients, 21 (51%) patients achieved > or =40% reduction in urinary Ntelopeptide by week 12, with 33 (80%) achieving some level of reduction anytime on study. Of 15 patients with elevated urinary Ntelopeptide at baseline, 8 (53%) normalized on study. Of 40 evaluable patients, 24 (60%) had reduction in bone alkaline phosphatase at week 12 and 25 (63%) achieved some reduction on study. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Dasatinib was generally well tolerated and treatmentrelated adverse events were moderate. |
| Conclusions: | This study provides encouraging evidence of dasatinib activity in bone and reasonable tolerability in chemotherapynaive patients with metastatic CRPC. |