Study of CMAB009 to Treat KRAS Wild Type Metastatic Colorectal Cancer (CRC009)

April 8, 2019 updated by: Shanghai Zhangjiang Biotechnology Limited Company

CMAB009 Plus Irinotecan Versus Irinotecan-only as Second-line Treatment After Fluoropyrimidine and Oxaliplatin Failure in KRAS Wild-type Metastatic Colorectal Cancer Patients: Prospective, Open-label, Randomized, Phase II/III Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

CMAB009 is a recombinant, human/mouse chimeric monoclonal antibody (mAb) that binds specifically to the extracellular domain of EGFR. It is composed of the Fv regions of a murine anti-EGFR antibody with human IgG1 heavy and k light chain constant regions and it is expressed by Chinese hamster ovary cells. It has the same amino acid sequence as cetuximab (C225, Erbitux®) , but it has slightly different abilities for glycosylation and other post-translational modifications, and it is developed by Shanghai Zhangjiang Biotechnology Limited Company and produced by Biomabs. Phase I study results suggest that CMAB009 showed well-tolerated safety profile and primary efficacy. This multicenter, open-label study was to determine whether adding CMAB009 to irinotecan increased the response rate and prolongs survival in patients with KRAS wild-type metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine and oxaliplatin.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
512

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CMAB009 plus Irinotecan
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
Other Names:
  • YiMaiLin for irinotecan
Active Comparator: Irinotecan-only and sequential-CMAB009
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.
Other Names:
  • YiMaiLin for irinotecan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall response rate
Time Frame: Time to progression, assessed up to two years
Tumor response was evaluated every 6 weeks and confirmed at least 4 weeks later
Time to progression, assessed up to two years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: Time to progression, assessed up to two years
The study was designed to evaluate the PFS as second end point, progression-free survival is defined as the period from date of randomization to date of disease progression
Time to progression, assessed up to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Zhangjiang Biotechnology Limited Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Biomabs Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yuankai Shi, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Principal Investigator: 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, First Affiliated Hospital Bengbu Medical College
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 23, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMAB009mCRCⅡ/Ⅲ
  • CMAB009 (Registry Identifier: 2007L02499)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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