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 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT01624467
Eligibility Criteria:
Inclusion Criteria:
* Have documented advanced or metastatic malignant solid tumors (except for colorectal tumors with KRAS mutation) that have not responded to standard therapy or for which no standard therapy is available
* May have measurable or non-measurable disease
* Have resolution to Grade 0 or 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE 4.0) of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy
* Have an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1
* Have adequate hepatic, renal and hematologic function
* Have potassium, magnesium, and calcium within normal limits
* Subjects, if female, are surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method during and for 6 months after the treatment period. If male, participants are surgically sterile or compliant with a highly effective contraceptive regimen during and for 6 months after the treatment period
* Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization
Exclusion Criteria:
* Are currently enrolled in, or discontinued a clinical trial involving an anticancer investigational product, or concurrently enrolled in any other type of medical research
* Had therapeutic radiotherapy within 14 days prior to the first dose of study therapy
* Have received necitumumab or any other monoclonal antibody (mAb) targeting the EGFR (epidermal growth factor receptor) as the most recent prior treatment
* Have documented and/or symptomatic brain or leptomeningeal metastases
* Have a clinically relevant abnormality on the ECG, preventing an accurate measurement of the QT interval
* Have current clinically-relevant coronary artery disease or uncontrolled congestive heart failure
* Have medically uncontrolled angina pectoris, or has experienced myocardial infarction within 6 months prior to the first dose of study therapy
* Have an implantable pacemaker or automatic implantable cardioverter defibrillator
* Have received sotalol within 10 days prior to the first dose of study therapy
* Have a history of risk factors for ventricular tachycardia or Torsades de pointes, history of fainting, unexplained loss of consciousness, or convulsions
* Have a history of heart failure, congestive heart failure, myocardial infarction, cardiomyopathy, hypokalemia, hypoglycemia, or hypomagnesia
* Have any evidence of conduction abnormality (eg, increased QRS complex)
* Have congenital long QT syndrome
* Have a prolonged QTc interval mean on pretreatment ECG
* Have a heart rate \< 50 bpm or \> 100 bpm at rest
* Are using a medication that is known to prolong the ECG QT interval, or have received a medication known to prolong the ECG QT interval within 14 days prior to first dose of study therapy
* Have a known allergy / history of hypersensitivity reaction to any of the treatment components, including any ingredient used in the formulation of necitumumab, or a known history of severe (Grade 3-4) hypersensitivity reaction to any monoclonal antibody
* Have an ongoing or active infection (requiring treatment), including active tuberculosis or known infection with the human immunodeficiency virus
* If female, are pregnant or breastfeeding
* Have a history of significant neurological or psychiatric disorders, including dementia, seizures, or bipolar disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01624467
Study Brief:
Protocol Section:
NCT01624467