Overview

This trial is active, not recruiting.

Condition solid tumors
Treatment necitumumab
Phase phase 2
Target EGFR
Sponsor Eli Lilly and Company
Start date August 2012
End date May 2014
Trial size 78 participants
Trial identifier NCT01624467, 14472, CP11-1114, I4X-IE-JFCI

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
800 mg necitumumab, administered once per week as an intervenous infusion
necitumumab IMC-11F8
800 mg necitumumab, administered once per week as an intervenous infusion

Primary Outcomes

Measure
Change from baseline in QT interval corrected for heart rate (QTc)
time frame: Prior to first dose through Cycle 1 (6 weeks)

Secondary Outcomes

Measure
Electrocardiographic Parameters: QRS Interval
time frame: Prior to first dose through Cycle 4 (24 weeks)
Electrocardiographic Parameters: PR interval
time frame: Prior to first dose through Cycle 4 (24 weeks)
Electrocardiographic Parameters: Heart Rate (HR)
time frame: Prior to first dose through Cycle 4 (24 weeks)
Pharmacokinetics: area under the concentration-time curve of necitumumab
time frame: Cycle 1: Day 1, 8, 15, 22, 29, and 36 and Cycles 2-4: Day 1
Pharmacokinetics: maximum drug concentration (Cmax) of necitumumab
time frame: Cycle 1: Day 1, 8, 15, 22, 29, and 36 and Cycles 2-4: Day 1
Tumor response rate per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
time frame: Prior to first dose, every 6 weeks after first dose of necitumumab, and at end of therapy
Incidence of anti-necitumumab antibodies
time frame: Prior to first dose, every 6 weeks after first dose, and 30 days after last dose of necitumumab

Eligibility Criteria

Male or female participants at least 18 years old.

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, patients 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 targeting the EGFR 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

Additional Information

Official title A Study to Determine Whether Necitumumab (IMC-11F8) Monotherapy Affects the Corrected QT (QTc) Interval in Patients With Advanced Solid Tumors
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.