Trial | NCT01550055  Report issue

Title

Study of CMAB009 to Treat KRAS Wild Type Metastatic Colorectal Cancer
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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    irinotecan cetuximab ...

  • Study Participants

    512
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
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 Started
May 31
2009
Primary Completion
Dec 23
2012
Study Completion
Jul 23
2015
Last Update
Apr 10
2019

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

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

CMAB009 plus Irinotecan Experimental

Irinotecan-only and sequential-CMAB009 Active Comparator

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
No Results Posted