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

Lilly

Status and phase

Completed

Phase 2

Conditions

Solid Tumors

Treatments

Biological: Necitumumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01624467

I4X-IE-JFCI (Other Identifier)

14472

CP11-1114 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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