Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT01228734
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent (first and second)
* Chinese with Chinese citizenship
* Male or female subjects greater than or equal to (\>=) 18 years of age
* Medically accepted effective contraception if procreative potential exists (applicable for both male and female subjects until at least 90 days after the last dose of trial treatment)
* Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
* First occurrence of metastatic disease (not curatively resectable) RAS wild-type status in tumor tissue
* At least one measurable lesion by computer tomography (CT) or magnetic resonance imaging (MRI) according to RECIST (not in an irradiated area)
* 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 \>= 100 × 10x9/L and hemoglobin \>= 6.21 mmol/L (10 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
* Recovery from relevant toxicity due to previous treatment before trial entry
Exclusion Criteria:
* Previous chemotherapy for CRC except adjuvant treatment if terminated \> 9 months (oxaliplatin-based chemotherapy) or \> 6 months (non-oxaliplatin-based chemotherapy) before the start of treatment in this trial
* Radiotherapy or surgery (excluding prior diagnostic biopsy) in the 30 days before trial treatment
* Previous treatment with monoclonal antibody therapy, vascular endothelial growth factor (VEGF) pathway-targeting therapy, epidermal growth factor receptor (EGFR) pathway-targeting therapy, or other signal transduction inhibitors
* History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation
* Renal replacement therapy
* Intake of any investigational medication within 30 days before trial entry
* Concurrent chronic systemic immune therapy or hormone therapy except physiologic replacement
* Granulocyte colony stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF) within 3 weeks of trial entry (these growth factors may be used during the trial thereafter)
* Other non-permitted concomitant anticancer therapies
* Known brain metastasis and/or leptomeningeal disease. Subjects with neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis
* Previous malignancy other than CRC in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
* 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
* Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
* Active clinically serious infections (\> grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0), including active tuberculosis
* Known and declared history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
* Peripheral neuropathy \> grade 1
* Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such
* Uncontrolled diabetes mellitus, pulmonary fibrosis, acute pulmonary disorder, interstitial pneumonia, or liver failure
* Known hypersensitivity or allergic reactions against any of the components of the trial treatments
* Pregnancy (absence to be confirmed by serum β-human chorionic gonadotropin test) or breastfeeding
* Ongoing alcohol or drug abuse
* Presence of a medical or psychological condition that would not permit the subject to complete the trial or sign informed consent
* Participation in another clinical trial within the past 30 days
* Other significant disease that in the investigator's opinion should exclude the subject from the trial
* Legal incapacity or limited legal capacity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01228734
Study Brief:
Protocol Section:
NCT01228734