A Study of Necitumumab Monotherapy and the QT/QTc Interval in Patient With Advanced Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Intervention: Necitumumab
Intervention description: 800 mg necitumumab, administered once per week IV
Intervention MeSH terms: Necitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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 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