Entry Detail
| General information | |
| Database: | DB00044 |
| Objective: | To determine the activity and tolerability of 100mg oncedaily (QD) dasatinib in patients with metastatic castrationresistance prostate cancer (CRPC). Dasatinib, an oral Src family kinase inhibitor, has demonstrated both preclinical and clinical activity with twicedaily dosing in patients with metastatic CRPC. |
| Authors: | Yu EY, et al |
| Title: | Oncedaily dasatinib: expansion of phase II study evaluating safety and efficacy of dasatinib in patients with metastatic castrationresistant prostate cancer. |
| Journal: | Urology |
| Year: | 2011 |
| PMID: | 21539969 |
| Trial Design | |
| Clinical Trial Id: | CA180085 |
| Agent: | dasatinib |
| Target: | Protooncogene tyrosineprotein kinase SRC Abl Protooncogene tyrosineprotein kinase LCK Protooncogene tyrosineprotein kinase Fyn |
| Cancer Type: | prostate cancer |
| Cancer Subtype: | advanced colorectal cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | expansion ofphase II openlabel multicenter study |
| Key Patients Feature: | Chemotherapynaive men with metastatic CRPC and increasing prostatespecific antigen levels at 12 centers in the United States, Italy, and France. |
| 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 mg QD |
| Primary End Point: | The primary measurement was a composite lack of disease progression, determined every 12 weeks during the study. |
| Secondary End Point: | changes in the prostatespecific antigen level, bone lesions, soft tissue disease, and bone turnover markers (urine Ntelopeptide and bone alkaline phosphatase). |
| Patients Number: | 48 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | A lack of disease progression was observed in 21 patients (44%) at week 12 and in 8 (17%) at week 24. Urine Ntelopeptide was reduced by more than and equal to 40% from baseline in 22 (51%) of 43 patients, and bone alkaline phosphatase was decreased in 26 (59%) of 44 patients. |
| 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 welltolerated, with only 6 patients (13%) with drugrelated grade 34 adverse events and 3 (6%) with grade 3 adverse events. The most common treatmentrelated adverse events (more than and equal to 20%) were fatigue, nausea, diarrhea, headache, and anorexia. |
| Conclusions: | Dasatinib 100 mg QD has a favorable safety profile and maintains a similar degree of activity as the previously reported twicedaily dosing schedules. These data support additional study of dasatinib 100 mg QD for metastatic CRPC. |