Study of CMAB009 to Treat KRAS Wild Type Metastatic Colorectal Cancer

NCT01550055 | Completed Phase 2 DMC

• 2 other identifiers: CMAB009mCRCⅡ/ⅢCMAB009
• Study Type: interventional
• Target: 512
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

KRAS wild-type; Metastatic Colorectal Cancer; CMAB009 Plus Irinotecan; Phase II/III

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Tumor response was evaluated every 6 weeks and confirmed at least 4 weeks later

  Time to progression, assessed up to two years

Secondary Outcomes (1)

• Progression-free Survival

  Time to progression, assessed up to two years

Study Arms (2)

CMAB009 plus Irinotecan

EXPERIMENTAL

Drug: CMAB009 plus Irinotecan

Irinotecan-only and sequential-CMAB009

ACTIVE COMPARATOR

Drug: Irinotecan-only and sequential-CMAB009

Interventions

CMAB009 plus Irinotecan DRUG

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

Also known as: YiMaiLin for irinotecan

CMAB009 plus Irinotecan

Irinotecan-only and sequential-CMAB009 DRUG

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.

Also known as: YiMaiLin for irinotecan

Irinotecan-only and sequential-CMAB009

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically confirmed metastatic colorectal adenocarcinoma
• 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

You may not qualify if:

• Previous irinotecan or anti-EGFR therapies
• 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

Sponsors & Collaborators

• Shanghai Zhangjiang Biotechnology Limited Company: lead
• Shanghai Biomabs Pharmaceutical Co., Ltd.: collaborator

Related Publications (1)

• 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.

  PMID: 31126331 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

CMAB009; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Yuankai Shi, M.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

• B C Mei

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• B Li

  Chinese PLA Affiliated Central Hospital

  PRINCIPAL INVESTIGATOR

• X J Ming

  Affiliated Hospital of Chinese PLA Military Academy of Medical Science

  PRINCIPAL INVESTIGATOR

• B Yi

  TianJin Medical University Affiliated Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Y Qiang

  NanKai University Affiliated Hospital

  PRINCIPAL INVESTIGATOR

• L Wei

  HeBei Medical University Fouth Hospital

  PRINCIPAL INVESTIGATOR

• L Y Peng

  Chinese Medical University First Affiliated Hospital

  PRINCIPAL INVESTIGATOR

• W B Cheng

  Jinan Military Central Hospital

  PRINCIPAL INVESTIGATOR

• W Z Hai

  Shandong Provincal Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Y S Ying

  Tongji Medical College of Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

• L Yi

  Hunan Provincal Cancer Hospital

  PRINCIPAL INVESTIGATOR

• C Y Gui

  Fujian Provincal Cancer Hospital

  PRINCIPAL INVESTIGATOR

• W L Wei

  Shanghai Jiaotong University Affiliated First People's Hospital

  PRINCIPAL INVESTIGATOR

• Z Jun

  Shanghai Jiaotong University Affiliated Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• H C Hong

  Central South University

  PRINCIPAL INVESTIGATOR

• OY Xuenong

  Fuzhou Central Hospital of Nanjing Military Command

  PRINCIPAL INVESTIGATOR

• L Jin

  Fudan University Affiliated Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Z Y Ping

  Zhejiang Provincal Cancer Hospital

  PRINCIPAL INVESTIGATOR

• H X Hua

  Guangxi Medical University Affiliated Cancer Hospital

  PRINCIPAL INVESTIGATOR

• L R Cheng

  Nanfang Medical University Affiliated Nanfang Hospital

  PRINCIPAL INVESTIGATOR

• L Y Hong

  Zhongshan University Affliated Cancer Hospital

  PRINCIPAL INVESTIGATOR

• T Min

  Suzhou University Affiliated First Hospital

  PRINCIPAL INVESTIGATOR

• Z Z Xiang

  Suzhou University Affiliated Second Hospital

  PRINCIPAL INVESTIGATOR

• C Ying

  Jilin Provincal Cancer Hospital

  PRINCIPAL INVESTIGATOR

• F J Feng

  Jiangsu Provincal Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Q S Qui

  Chinese PLA Affiliated 81 Hospital

  PRINCIPAL INVESTIGATOR

• J Bin

  Shanghai Jiaotong University Affiliated Third People's Hospital

  PRINCIPAL INVESTIGATOR

• Z R Sheng

  The First Affiliated Hospital of Bengbu Medical University

  PRINCIPAL INVESTIGATOR

• M G Xin

  Nantong Medical College Affiliated Hospital

  PRINCIPAL INVESTIGATOR

• S G Ping

  Anhui Medical University Affiliated First Hospital

  PRINCIPAL INVESTIGATOR

• D W Chao

  The Fourth Military University Affiliated First Hospital

  PRINCIPAL INVESTIGATOR

• L H Jie

  The Third Military University Affiliated First Hospital

  PRINCIPAL INVESTIGATOR

• X Ying

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

• F Min

  Chongqing First People's Hospital

  PRINCIPAL INVESTIGATOR

• B Feng

  Sichuan University Huaxi Hospital

  PRINCIPAL INVESTIGATOR

• W D Lin

  Sichuan Provincal People's Hospital

  PRINCIPAL INVESTIGATOR

• Z W Hua

  Gansu Provincal Cancer Hospital

  PRINCIPAL INVESTIGATOR

• C Hong

  Kunming Central Hospital of Chengdu Military Command

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 9, 2012
• Study Start: May 31, 2009
• Primary Completion: December 23, 2012
• Study Completion: July 23, 2015
• Last Updated: April 10, 2019

Record last verified: 2019-04