Entry Detail
| General information | |
| Database: | DB00471 |
| Objective: | In this paper they illustrate the SOAP study, which was designed to evaluate the safety and efficacy of sorafenib in terms of progression freesurvival in 44 patients treated in 10 Italian centers who had relapsed after firstline pazopanib. |
| Authors: | Iacovelli R, et al |
| Title: | Rationale and protocol of SOAP: a phase II study to evaluate the efficacy of sorafenib as secondline treatment after pazopanib in patients with advanced renal cell carcinoma. |
| Journal: | Tumori. |
| Year: | 2014 |
| PMID: | 25688511 |
| Trial Design | |
| Clinical Trial Id: | NCT02122003 |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | renal cell carcinoma |
| Cancer Subtype: | advanced renal cell carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II study |
| Key Patients Feature: | patients with advanced renal cell carcinoma |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Standard treatment with sorafenib will be administered until disease progression or unacceptable toxicity. |
| Primary End Point: | safety and efficacy |
| Secondary End Point: | the evaluation of overall survival, safety and quality of life. |
| Patients Number: | 44 |
| 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 |