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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01624467
First received: May 24, 2012
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Solid Tumors
Biological: necitumumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Determine Whether Necitumumab (IMC-11F8) Monotherapy Affects the Corrected QT (QTc) Interval in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline in QT interval corrected for heart rate (QTc) [ Time Frame: Prior to first dose through Cycle 1 (6 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Electrocardiographic Parameters: QRS Interval [ Time Frame: Prior to first dose through Cycle 4 (24 weeks) ] [ Designated as safety issue: No ]
  • Electrocardiographic Parameters: PR interval [ Time Frame: Prior to first dose through Cycle 4 (24 weeks) ] [ Designated as safety issue: No ]
  • Electrocardiographic Parameters: Heart Rate (HR) [ Time Frame: Prior to first dose through Cycle 4 (24 weeks) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Study Completion Date: November 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: necitumumab
800 mg necitumumab, administered once per week as an intervenous infusion
Biological: necitumumab
800 mg necitumumab, administered once per week as an intervenous infusion
Other Names:
  • IMC-11F8
  • LY3012211

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624467

Locations
United States, Michigan
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, 48109
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, 48201
United States, Nevada
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, 89169
United States, New Jersey
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, 08901
United States, 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.
Huntersville, North Carolina, United States, 28078
United States, Ohio
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, 44195
United States, Pennsylvania
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, 15213
United States, Utah
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, 84112
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01624467     History of Changes
Other Study ID Numbers: 14472, CP11-1114, I4X-IE-JFCI
Study First Received: May 24, 2012
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Advanced Solid Tumors

Additional relevant MeSH terms:
Neoplasms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014