Pharmacokinetics Study of Nimotuzumab in Patients With Solid Tumors

PHASE1UnknownINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

November 30, 2014

Study Completion Date

December 31, 2015

Conditions
Solid Tumors
Interventions
DRUG

Nimotuzumab

single dose of nimotuzumab (100、200、400、600mg), with 3 weeks observation;Set 4 dose groups for Nimotuzumab, namely 100,200,400,600mg. Each group administered once a week for 6 weeks;600mg, administered once every 2 weeks for 8 weeks.

DRUG

irinotecan

"Single-dose PK:1 week after nimotuzumb administration, irinotecan (CPT-11) will be given at a dose of 180 mg/m2 once every 2 weeks, 2 weeks a cycle.~Bioweekly fixed dose PK:Nimotuzumab combined with irinotecan (180mg/m2), administering once every 2 weeks and considering 2 weeks as a period. If chemotherapy and Nimotuzumab are administered in the same day, chemotherapy should be infused after Nimotuzumab for at least 1h"

Trial Locations (1)

100000

Cancer Institute & Hospital, Chinese Academy of Medical Sciences, Beijing

All Listed Sponsors
lead

Biotech Pharmaceutical Co., Ltd.

OTHER