Entry Detail
| General information | |
| Database: | DB00925 |
| Objective: | they investigated the activity and safety of sorafenib, a multitargeted tyrosinekinase inhibitor, in patients with advanced soft tissue sarcomas (STS). |
| Authors: | Santoro A, et al |
| Title: | Phase II prospective study with sorafenib in advanced soft tissue sarcomas after anthracyclinebased therapy. |
| Journal: | Ann Oncol. |
| Year: | 2013 |
| PMID: | 23230134 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | soft tissue sarcomas |
| Cancer Subtype: | advanced soft tissue sarcomas |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | An openlabel nonrandomised multicentrephase II study |
| Key Patients Feature: | advanced STS(soft tissue sarcomas) patients pretreated with anthracyclinebased chemotherapy |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received sorafenib 400 mg twice daily for 28 days. |
| Primary End Point: | the progression free survival (PFS) rate at 6 months. Toxicity was assessed. Clinical outcomes were evaluated in all histologies and in leiomyosarcoma (L) and angiovascular sarcomas (A). |
| Secondary End Point: | NA |
| Patients Number: | 101 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | 14.50% |
| Disease Control Rate: | 47.40% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.2 months |
| Median OS A vs. C: | 11.9 months |
| Adverse Event(agent arm): | NA |
| Conclusions: | Sorafenib appears to be a promising option in leiomyosarcoma patients. This finding warrants further evaluation in histologydriven trials. |