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

STATUS

Recruiting
End date

Dec 22, 2023
participants needed

570
sponsor

Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

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Updated on 26 February 2022

See if I qualify

platelet count

measurable disease

growth factor

neutrophil count

EGFR

cetuximab

adenocarcinoma

adenocarcinoma of colon

modified folfox6

Summary

The study is an double blind, randomized, multicenter phase 3 trial. The efficacy analyses are based on 570 Chinese patients with RAS wt mCRC treated with mFOLFOX-6 cetuximab. Study treatment continues until disease progression or unacceptable toxicity (ie, not for a fixed number of courses). The primary endpoint of the study is progression-free survival (PFS) time according to RECIST 1.0; key secondary endpoints include overall survival (OS) time, overall response rate (ORR), and safety/tolerability.

Details

Condition	Metastatic Colorectal Cancer
Treatment	Placebo, KL-140
Clinical Study Identifier	NCT03426371
Sponsor	Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Last Modified on	26 February 2022

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Eligibility		Yes	No	Not Sure
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 metastasisSerum 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 diseaseexcept 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 entryblood transfusionor blood components transfusion
	Pregnancy (absence to be confirmed by serum -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

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