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

NCT ID: NCT01624467

Last Updated: 2016-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-06-30

Brief 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.

Conditions

Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Necitumumab

800 mg necitumumab, administered once per week as an intravenous infusion (IV)

Group Type: EXPERIMENTAL

Necitumumab

Intervention Type: BIOLOGICAL

800 mg necitumumab, administered once per week IV

Interventions

Necitumumab

800 mg necitumumab, administered once per week IV

Intervention Type: BIOLOGICAL

Other Intervention Names

IMC-11F8; LY3012211

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

Countries

United States

Other Identifiers

CP11-1114

Identifier Type: OTHER

Identifier Source: secondary_id

I4X-IE-JFCI

Identifier Type: OTHER

Identifier Source: secondary_id

14472

Identifier Type: -

Identifier Source: org_study_id