Entry Detail
| General information | |
| Database: | DB00216 |
| Objective: | Sunitinib is approved multinationally for renal cell carcinoma and gastrointestinal stromal tumors. a phase II trial was conducted to examine the efficacy and toxicities of sunitinib in metastatic CRPC progressing after 12 previous chemotherapy regimens including docetaxel. |
| Authors: | Sonpavde G |
| Title: | Phase II trial of sunitinib for the therapy of progressive metastatic castrationrefractory prostate cancer after previous docetaxel chemotherapy. |
| Journal: | Clin Genitourin Cancer |
| Year: | 2008 |
| PMID: | 18824440 |
| Trial Design | |
| Clinical Trial Id: | NA |
| 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 castrationresistant prostate cancer. |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a multicenter, Istage, phase II study |
| Key Patients Feature: | patients with Progressive Metastatic CastrationRefractory Prostate Cancer After Previous Docetaxel Chemotherapy |
| Biomarker: | PSA |
| Biomark Analysis: | Serum prostatespecific antigen levels were prospectively monitored as a biomarker for cancer activity. |
| Control Group Info: | single arm |
| Treatment Info: | Sunitinib 50 mg is administered orally once daily for 4 weeksof every 6week cycle. Therapy will continue until progression or severe toxicities and for less than and equal to 8 cycles. |
| Primary End Point: | PFS. |
| Secondary End Point: | PSA response, Change in PSA doubling time. |
| Patients Number: | 34 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | pending |
| Disease Control Rate: | pending |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | pending |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | pending |
| Conclusions: | pending |