Study of CMAB009 to Treat KRAS Wild Type Metastatic Colorectal Cancer

Summary

The primary purpose of this study is to evaluate the clinical response and safety of CMAB009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients

Conditions

• Metastatic Colorectal Cancer

Interventions

DRUG

CMAB009 plus Irinotecan

Combined with irinotecan 180 mg/m2 every 2 weeks, CMAB009 400 mg/m2 day 1 followed by 250 mg/m2 weekly till disease progression

DRUG

Irinotecan-only and sequential-CMAB009

First, irinotecan 180 mg/m2 every 2 weeks till PD occured, discontinue it; then, CMAB009 400 mg/m2 day 1 followed by 250 mg/m2 weekly till disease progression.

Sponsors & Collaborators

• Shanghai Biomabs Pharmaceutical Co., Ltd.

  collaborator INDUSTRY

• Shanghai Zhangjiang Biotechnology Limited Company

  lead INDUSTRY

Principal Investigators

• Yuankai Shi, M.D. · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

• B C Mei · Peking Union Medical College Hospital

• B Li · Chinese PLA Affiliated Central Hospital

• X J Ming · Affiliated Hospital of Chinese PLA Military Academy of Medical Science

• B Yi · TianJin Medical University Affiliated Cancer Hospital

• Y Qiang · NanKai University Affiliated Hospital

• L Wei · HeBei Medical University Fouth Hospital

• L Y Peng · Chinese Medical University First Affiliated Hospital

• W B Cheng · Jinan Military Central Hospital

• W Z Hai · Shandong Provincal Cancer Hospital

• Y S Ying · Tongji Medical College of Huazhong University of Science and Technology

• L Yi · Hunan Provincal Cancer Hospital

• C Y Gui · Fujian Provincal Cancer Hospital

• W L Wei · Shanghai Jiaotong University Affiliated First People's Hospital

• Z Jun · Shanghai Jiaotong University Affiliated Ruijin Hospital

• H C Hong · Central South University

• OY Xuenong · Fuzhou Central Hospital of Nanjing Military Command

• L Jin · Fudan University Affiliated Cancer Hospital

• Z Y Ping · Zhejiang Provincal Cancer Hospital

• H X Hua · Guangxi Medical University Affiliated Cancer Hospital

• L R Cheng · Nanfang Medical University Affiliated Nanfang Hospital

• L Y Hong · Zhongshan University Affliated Cancer Hospital

• T Min · Suzhou University Affiliated First Hospital

• Z Z Xiang · Suzhou University Affiliated Second Hospital

• C Ying · Jilin Provincal Cancer Hospital

• F J Feng · Jiangsu Provincal Cancer Hospital

• Q S Qui · Chinese PLA Affiliated 81 Hospital

• J Bin · Shanghai Jiaotong University Affiliated Third People's Hospital

• Z R Sheng · The First Affiliated Hospital of Bengbu Medical University

• M G Xin · Nantong Medical College Affiliated Hospital

• S G Ping · Anhui Medical University Affiliated First Hospital

• D W Chao · The Fourth Military University Affiliated First Hospital

• L H Jie · The Third Military University Affiliated First Hospital

• X Ying · Chongqing University Cancer Hospital

• F Min · Chongqing First People's Hospital

• B Feng · Sichuan University Huaxi Hospital

• W D Lin · Sichuan Provincal People's Hospital

• Z W Hua · Gansu Provincal Cancer Hospital

• C Hong · Kunming Central Hospital of Chengdu Military Command

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-05-31

Primary Completion

2012-12-23

Completion

2015-07-23