Study to Evaluate the Effect of Cetuximab on Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors
Condition: Advanced Cancer
MeSH terms: Neoplasms
Intervention: Cetuximab
Intervention description: Cetuximab administered by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether corrected QT (QTc) interval changes occur
      on an electrocardiogram (ECG) when cetuximab is administered to the study population.
    

Eligibility criteria:

        Inclusion criteria:

          -  Advanced or metastatic malignant disease originating from solid tumors

          -  Adequate recovery from previous therapy or intervention; at least 21 days since major
             surgery or prior radiation therapy

          -  Measurable or evaluable disease

        Exclusion criteria:

          -  Women of childbearing potential (WOCBP) who are breastfeeding, pregnant, or unwilling
             or unable to use acceptable contraception during the study and for at least 12 weeks
             after the last on-study dose of cetuximab

          -  Men unwilling to use acceptable contraception during the study if engaged in sexual
             relations with a WOCBP

          -  Symptomatic brain metastasis

          -  History of myocardial infarction 6 months or less prior to study entry, of severe
             congestive heart failure, of uncontrolled angina, or of uncontrolled arrhythmias

          -  Clinically relevant abnormality on screening electrocardiogram (ECG), preventing an
             accurate measurement of the QT interval

          -  Congenital long QT syndrome

          -  History of risk factors for ventricular tachycardia or Torsades de pointes or history
             of fainting, unexplained loss of consciousness, or convulsions

          -  Prolonged QTc interval on screening ECG (greater than 470 msec) using Fridericia's
             correction formula

          -  Heart rate slower than 50 bpm or faster than 100 bpm at rest during screening ECG
             measurements

          -  Implantable pacemaker or automatic implantable cardioverter defibrillator

          -  Sustained supine systolic blood pressure higher than 150 mmHg or lower than 90 mmHg or
             a diastolic blood pressure lower than 45 mmHg or higher than 95 mmHg at screening

          -  Known history of arterial thrombotic events within 6 months prior to study initiation

          -  Known history of significant peripheral artery disease

          -  Current participation in a clinical trial with another investigational new drug or
             device

          -  Receipt of an investigational new drug or device within 21 days prior to enrollment in
             this study