Entry Detail
| General information | |
| Database: | DB00215 |
| Objective: | This study explored the efficacy and tolerability of sunitinib, an inhibitor of tyrosine kinase receptors, in men with castrationresistant prostate cancer (CRPC). |
| Authors: | Dror Michaelson M |
| Title: | Phase II study of sunitinib in men with advanced prostate cancer. |
| Journal: | Ann Oncol. |
| Year: | 2009 |
| PMID: | 19403935 |
| Trial Design | |
| Clinical Trial Id: | PC050010 |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | prostate cancer |
| Cancer Subtype: | advanced prostate cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase II study |
| Key Patients Feature: | Men with no prior chemotherapy (group A) and men with docetaxel (Taxotere)resistant prostate cancer (group B) |
| Biomarker: | PSA; |
| Biomark Analysis: | Serumsoluble biomarkers were measured: Significant changes following sunitinib treatment were observed in serumsoluble biomarkers including soluble vascular endothelial growth factor receptor2, plateletderived growth factor aa, placental growth factor and leptin. |
| Control Group Info: | Men with no prior chemotherapy (group A) versus men with docetaxel (Taxotere)resistant prostate cancer (group B) |
| Treatment Info: | Men with no prior chemotherapy (group A) and men with docetaxel (Taxotere)resistant prostate cancer (group B) were treated with sunitinib. |
| Primary End Point: | 50% prostatespecific antigen (PSA) decline. |
| Secondary End Point: | objective response rate and safety. |
| Patients Number: | 17 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | One confirmed PSA response was observed in each group, and an additional eight men and seven men had stable PSA at week 12 in groups A and B, respectively. Improvements in imaging were observed in the absence of posttreatment PSA declines. |
| 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): | Common adverse effects included fatigue, nausea, diarrhea, myelosuppression and transaminase elevation. |
| Conclusions: | Sunitinib monotherapy resulted in few confirmed 50% posttreatment declines in PSA in men with CRPC. Serum markers of angiogenesis confirmed ontarget effects of sunitinib. Assessments of radiographic disease status were often discordant with changes in PSA, indicating that alternate end points are important in future trials. |