Epidermal Growth Factor Receptor (EGFR) Antagonist Chimeric Anti-EGFR Monoclonal Antibody Trial

Launched by SICHUAN KELUN PHARMACEUTICAL RESEARCH INSTITUTE CO., LTD. · Feb 7, 2018

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed written informed consent
• • Male or female subjects， 18-75 years of age
• • Medically accepted effective contraception if procreative potential exists
• • Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
• • RAS wild-type and BRAF-V600E wild-type status in tumor tissue
• • At least one measurable lesion by computer tomography (CT) or magnetic resonance imaging (MRI) according to RECIST
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at trial entry
• • Life expectancy of at least 12 weeks
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at trial entry
• • White blood cell count \>= 3 × 10x9/L with neutrophils \>= 1.5 × 10x9/L, platelet count \>=75 × 10x9/L and hemoglobin \>= 8 g/dL； Total bilirubin \<= 1.5 × upper limit of reference range， Aspartate transaminase (AST) and alanine transaminase (ALT) \<= 2.5 × upper limit of reference range or \<= 5 × upper reference range in subjects with liver metastasis；Serum creatinine \<= 1.5 × upper limit of reference range
• Exclusion Criteria:
• • Known hypersensitivity or allergic reactions against any of the components of the trial treatments
• • Radiotherapy or surgery (excluding prior diagnostic biopsy) in the 28 days before trial treatment
• • Known brain metastasis and/or leptomeningeal disease. Subjects with neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis
• • Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease，except the patient with fistulation or stenting
• • Active clinically serious infections (\> grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0), including active tuberculosis
• • Uncontrolled diabetes mellitus, pulmonary fibrosis, acute pulmonary disorder, interstitial pneumonia, or liver failure
• • Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 5 years, or left ventricular ejection fraction below the institutional range of normal on a baseline multiple gated acquisition scan or echocardiogram
• • Renal replacement therapy
• • Peripheral neuropathy \> grade 1
• • History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation
• • Previous malignancy other than CRC in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
• • Known and declared history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
• • Known severe coagulation disorders
• • Previous chemotherapy for CRC except adjuvant treatment if terminated \> 12 months (oxaliplatin-based chemotherapy) or \> 6 months (non-oxaliplatin-based chemotherapy) before the start of treatment in this trial
• • Previous treatment with anti-EGFR monoclonal antibody therapy
• • Other non-permitted concomitant anticancer therapies, chronic systemic immune therapy or hormone therapy
• • Granulocyte colony stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF) within 3 weeks of trial entry，blood transfusion，or blood components transfusion
• • Pregnancy (absence to be confirmed by serum β-human chorionic gonadotropin test) or breastfeeding
• • Ongoing alcohol or drug abuse
• • Known neurological or psychiatric diseases
• • Participation in another clinical trial within the past 4 weeks
• • Legal incapacity or limited legal capacity
• • Other significant disease that in the investigator's opinion should exclude the subject from the trial