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Study of Nimotuzumab to Treat Colorectal Cancer

NCT00972465 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2009-09-07

No results posted yet for this study

Summary

Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with advanced colorectal cancer.

Conditions

  • Advanced Colorectal Cancer

Interventions

DRUG

Nimotuzumab and chemotherapy

Experimental: Nimotuzumab and Irinotecan the chemotherapy treatment: Irinotecan (180 mg/m2/time, 1 time/14 days, until disease progression) the nimotuzumab treatment: 3 levels (200 mg/w, 400 mg/w, 600 mg/w, weekly, until disease progression)

Sponsors & Collaborators

  • Biotech Pharmaceutical Co., Ltd.

    collaborator OTHER

  • Peking University

    lead OTHER

Principal Investigators

  • Shen Lin · Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2009-12-31
Completion
2010-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00972465 on ClinicalTrials.gov