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

Primary Purpose

Metastatic Colorectal Cancer

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

CMAB009 plus Irinotecan

Irinotecan-only and sequential-CMAB009

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring KRAS wild-type, Metastatic Colorectal Cancer, CMAB009 Plus Irinotecan, Phase II/III

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CMAB009 plus Irinotecan

Irinotecan-only and sequential-CMAB009

Arm Description

Outcomes

Primary Outcome Measures

Overall response rate

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

Secondary Outcome Measures

Progression-free Survival

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

Full Information

NCT ID

NCT01550055

First Posted

March 7, 2012

Last Updated

April 8, 2019

Sponsor

Shanghai Zhangjiang Biotechnology Limited Company

Collaborators

Shanghai Biomabs Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01550055

Brief Title

Study of CMAB009 to Treat KRAS Wild Type Metastatic Colorectal Cancer

Acronym

CRC009

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

May 31, 2009 (Actual)

Primary Completion Date

December 23, 2012 (Actual)

Study Completion Date

July 23, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhangjiang Biotechnology Limited Company

Collaborators

Shanghai Biomabs Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Colorectal Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

512 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CMAB009 plus Irinotecan

Arm Type

Experimental

Arm Title

Irinotecan-only and sequential-CMAB009

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

CMAB009 plus Irinotecan

Other Intervention Name(s)

YiMaiLin for irinotecan

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Irinotecan-only and sequential-CMAB009

Other Intervention Name(s)

YiMaiLin for irinotecan

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overall response rate

Description

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

Time Frame

Time to progression, assessed up to two years

Secondary Outcome Measure Information:

Title

Progression-free Survival

Description

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 Frame

Time to progression, assessed up to two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: