Entry Detail
| General information | |
| Database: | DB00561 |
| Objective: | Thisphase II trial was designed to investigate the role of sunitinib as maintenance therapy in patients with advanced urothelial cancer. |
| Authors: | Bradley DA, et al |
| Title: | Randomized, doubleblind, placebocontrolledphase II trial of maintenance sunitinib versus placebo after chemotherapy for patients with advanced urothelial carcinoma: scientific rationale and study design. |
| Journal: | Clin Genitourin Cancer. |
| Year: | 2007 |
| PMID: | 18272031 |
| 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: | Urothelial Carcinoma |
| Cancer Subtype: | advanced urothelial carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Randomized, DoubleBlind, PlaceboControlledphase II Trial |
| Key Patients Feature: | Patients with advanced urothelial carcinoma who haveachieved SD or better after treatment with 46 cycles of combination chemotherapy will be enrolled. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | sunitinib versus placebo |
| Treatment Info: | Patients are randomized to receive sunitinib 50 mg or matching placebo in a doubleblind manner. Sunitinib will be given at 50 mg per day as a single agentfor 4 consecutive weeks follotheyd by a 2week rest period. |
| Primary End Point: | 6month progression rate (PR) |
| Secondary End Point: | objective RR, TTP, and median survival. Tertiary endpoints include RR and PR |
| Patients Number: | NA |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| 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): | NA |
| Conclusions: | NA |