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

Completed · Phase 2

Conditions studied: Solid Tumors

In brief

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.

Key facts

Study ID: NCT01624467
Run by: Eli Lilly and Company
People needed: 75
Starts: 2012-08-01
Expected to finish: 2015-06-01
Last updated by the study team: 2016-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Ann Arbor, Michigan, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Detroit, Michigan, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Las Vegas, Nevada, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — New Brunswick, New Jersey, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Huntersville, North Carolina, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Cleveland, Ohio, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Pittsburgh, Pennsylvania, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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