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A Study to Determine Whether Necitumumab (IMC-11F8) Monotherapy Affects the Corrected QT (QTc) Interval in Patients With Advanced Solid Tumors


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors

Thank you

Trial Information

A Study to Determine Whether Necitumumab (IMC-11F8) Monotherapy Affects the Corrected QT (QTc) Interval in Patients With Advanced Solid Tumors


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change from baseline in QT interval corrected for heart rate (QTc)

Outcome Time Frame:

Prior to first dose through Cycle 1 (6 weeks)

Safety Issue:

No

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

14472

NCT ID:

NCT01624467

Start Date:

August 2012

Completion Date:

August 2014

Related Keywords:

  • Solid Tumors
  • Advanced Solid Tumors
  • Neoplasms

Name

Location

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.Durham, North Carolina  
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.Kalamazoo, Michigan  49048
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  89169
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.Cherry Hill, New Jersey  08003
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.Cincinnati, Ohio  45267
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.Dunmore, Pennsylvania  18512
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  84106