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

This study is currently recruiting participants.
Verified March 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01624467
First received: May 24, 2012
Last updated: March 14, 2014
Last verified: March 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
Estimated Primary Completion Date: June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624467

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

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. Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Eli Lilly         
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. Recruiting
Detroit, Michigan, United States, 48201
Contact: Eli Lilly         
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. Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Eli Lilly         
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. Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Eli Lilly         
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. Recruiting
Huntersville, North Carolina, United States, 28078
Contact: Eli Lilly         
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. Recruiting
Cleveland, Ohio, United States, 44195
Contact: Eli Lilly         
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. Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Eli Lilly         
United States, Rhode Island
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. Not yet recruiting
Providence, Rhode Island, United States, 02906
Contact: Eli Lilly         
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. Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Eli Lilly         
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: March 14, 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 April 17, 2014