drugset / Trial / NCT02390947

Safety and Efficacy Study of Famitinib in Patients With Advanced Colorectal Adenocarcinoma(FACT)

NCT02390947

Phase 3 Completed 543 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3, whose anti-tumor and anti-angiogenesis effects have been validated in preclinical tests. In PhaseⅡb study, a significantly improved Progression Free Survival (PFS) was found in patients with advanced colorectal cancer treated with Famitinib compared to placebo. On the other hand, the toxicity of Famitinib was manageable in both PhaseⅠand Ⅱb studies. The purpose of this study is to determine whether Famitinib can improve Overall Survival (OS) compared with placebo in total 540 patients with advanced colorectal cancer who have failed in previously received at least two lines of standard chemotherapy.

Timeline

Start
2015-01
Primary completion
2019-02
Completion
2019-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Famitinib Small molecule 25 mg Oral