NCT02390947

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

A Multicenter，Randomized, Double-blind, Placebo-controlled Trial of Famitinib in Patients With Advanced Colorectal Adenocarcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 543 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer Metastatic
• Colorectal Cancer Recurrent

Interventions

Type	Name	Description
DRUG	Famitinib	25 mg p.o. qd
DRUG	Placebo	25 mg p.o. qd

Timeline

• Start date: 2015-01-01
• Primary completion: 2019-02-01
• Completion: 2019-07-01
• First posted: 2015-03-18
• Last updated: 2020-12-22

Locations

44 sites across 1 country: China