A Phase Ib Study of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection Plus FOLFIRI in Chinese Patients With Metastatic Colorectal Cancer

PHASE1UnknownINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

December 31, 2016

Conditions
Metastatic Colorectal Cancer
Interventions
DRUG

Sevacizumab

escalating doses of Sevacizumab : 3mg/kg,4mg/kg,5mg/kg

DRUG

Irinotecan

Irinotecan: IV solution, IV over 90 minutes, 180 mg/m², Every 14 days, Until disease progression/toxicity

DRUG

5-FU

5-FU: IV solution, IV bolus over 2-4 minutes, 400 mg/m²; IV infusion over 46 hours, 2400 mg/m²; Every 14 days, Until disease progression/toxicity

DRUG

Leucovorin

Leucovorin: IV solution, IV over 2 hours, 400 mg/m², Every 14 days, Until disease progression/toxicity

Trial Locations (3)

130021

RECRUITING

The First Bethune Hospital of Jilin University, Changchun

200032

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

310003

RECRUITING

The First Hospital of Zhejiang Province, Hangzhou

All Listed Sponsors
lead

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY