Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: A Study of Necitumumab Monotherapy and the QT/QTc Interval in Patient With Advanced Solid Tumors

Summary: The purpose of this study is to determine whether treatment with necitumumab monotherapy affects the QT/QTc interval among participants with advanced solid tumors refractory to standard treatment or for which no standard treatment is available.


Eligibility: 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

Relevance to patient case: not relevant