Study of CMAB009 to Treat KRAS Wild Type Metastatic Colorectal Cancer
NCT ID: NCT01550055
Last Updated: 2019-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
512 participants
INTERVENTIONAL
2009-05-31
2015-07-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CMAB009 plus Irinotecan
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
Irinotecan-only and sequential-CMAB009
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.
Interventions
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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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* KRAS wild-type tumors, EGFR-expressing or EGFR-nonexpressing by immunohistochemistry;
* has measurable lesion, at least 1cm in diametre by CT or MRI, at least 2cm diametre by physical examination or other iconography
* ECOG performance status 0 to 1
* Failure (disease progression/discontinuation due to toxicity) of fluoropyrimidine and oxaliplatin treatment,stop at least one month thereafter, irinotecan-naïve
Exclusion Criteria
* hematologic function: hemoglobin, less than 90g per liter; neutrophil count, less than 1500 per cubic millimeter; and platelet count, less than 100,000 per cubic millimeter
* liver function: bilirubin, more than 1.0 times the upper limit of normal; aspartate aminotransferase and alanine aminotransferase, more than 5.0 times and 2.5 times the upper limit of normal with hepatic metastasis or not
* Renal function: serum creatinine, more than 1.5 times the upper limit of normal
* Patients with symptomatic central nervous system metastases
18 Years
70 Years
ALL
No
Sponsors
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Shanghai Biomabs Pharmaceutical Co., Ltd.
INDUSTRY
Shanghai Zhangjiang Biotechnology Limited Company
INDUSTRY
Responsible Party
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Principal Investigators
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Yuankai Shi, M.D.
Role: STUDY_CHAIR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
B C Mei
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
B Li
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA Affiliated Central Hospital
X J Ming
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital of Chinese PLA Military Academy of Medical Science
B Yi
Role: PRINCIPAL_INVESTIGATOR
TianJin Medical University Affiliated Cancer Hospital
Y Qiang
Role: PRINCIPAL_INVESTIGATOR
NanKai University Affiliated Hospital
L Wei
Role: PRINCIPAL_INVESTIGATOR
HeBei Medical University Fouth Hospital
L Y Peng
Role: PRINCIPAL_INVESTIGATOR
Chinese Medical University First Affiliated Hospital
W B Cheng
Role: PRINCIPAL_INVESTIGATOR
Jinan Military Central Hospital
W Z Hai
Role: PRINCIPAL_INVESTIGATOR
Shandong Provincal Cancer Hospital
Y S Ying
Role: PRINCIPAL_INVESTIGATOR
Tongji Medical College of Huazhong University of Science and Technology
L Yi
Role: PRINCIPAL_INVESTIGATOR
Hunan Provincal Cancer Hospital
C Y Gui
Role: PRINCIPAL_INVESTIGATOR
Fujian Provincal Cancer Hospital
W L Wei
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiaotong University Affiliated First People's Hospital
Z Jun
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiaotong University Affiliated Ruijin Hospital
H C Hong
Role: PRINCIPAL_INVESTIGATOR
Central South University
OY Xuenong
Role: PRINCIPAL_INVESTIGATOR
Fuzhou Central Hospital of Nanjing Military Command
L Jin
Role: PRINCIPAL_INVESTIGATOR
Fudan University Affiliated Cancer Hospital
Z Y Ping
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Provincal Cancer Hospital
H X Hua
Role: PRINCIPAL_INVESTIGATOR
Guangxi Medical University Affiliated Cancer Hospital
L R Cheng
Role: PRINCIPAL_INVESTIGATOR
Nanfang Medical University Affiliated Nanfang Hospital
L Y Hong
Role: PRINCIPAL_INVESTIGATOR
Zhongshan University Affliated Cancer Hospital
T Min
Role: PRINCIPAL_INVESTIGATOR
Suzhou University Affiliated First Hospital
Z Z Xiang
Role: PRINCIPAL_INVESTIGATOR
Suzhou University Affiliated Second Hospital
C Ying
Role: PRINCIPAL_INVESTIGATOR
Jilin Provincal Cancer Hospital
F J Feng
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincal Cancer Hospital
Q S Qui
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA Affiliated 81 Hospital
J Bin
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiaotong University Affiliated Third People's Hospital
Z R Sheng
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Bengbu Medical University
M G Xin
Role: PRINCIPAL_INVESTIGATOR
Nantong Medical College Affiliated Hospital
S G Ping
Role: PRINCIPAL_INVESTIGATOR
Anhui Medical University Affiliated First Hospital
D W Chao
Role: PRINCIPAL_INVESTIGATOR
The Fourth Military University Affiliated First Hospital
L H Jie
Role: PRINCIPAL_INVESTIGATOR
The Third Military University Affiliated First Hospital
X Ying
Role: PRINCIPAL_INVESTIGATOR
Chongqing University Cancer Hospital
F Min
Role: PRINCIPAL_INVESTIGATOR
Chongqing First People's Hospital
B Feng
Role: PRINCIPAL_INVESTIGATOR
Sichuan University Huaxi Hospital
W D Lin
Role: PRINCIPAL_INVESTIGATOR
Sichuan Provincal People's Hospital
Z W Hua
Role: PRINCIPAL_INVESTIGATOR
Gansu Provincal Cancer Hospital
C Hong
Role: PRINCIPAL_INVESTIGATOR
Kunming Central Hospital of Chengdu Military Command
References
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Shi Y, Li J, Xu J, Sun Y, Wang L, Cheng Y, Liu W, Sun G, Chen Y, Bai L, Zhang Y, He X, Luo Y, Wang Z, Liu Y, Yao Q, Li Y, Qin S, Hu X, Bi F, Zheng R, Ouyang X. CMAB009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients: promising findings from a prospective, open-label, randomized, phase III trial. Cancer Commun (Lond). 2019 May 24;39(1):28. doi: 10.1186/s40880-019-0374-8.
Other Identifiers
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CMAB009
Identifier Type: REGISTRY
Identifier Source: secondary_id
CMAB009mCRCⅡ/Ⅲ
Identifier Type: -
Identifier Source: org_study_id
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