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Trial record 1 of 1 for:    Necitumumab, CP11-1114
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A Study of Necitumumab Monotherapy and the QT/QTc Interval in Patient With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT01624467
Recruitment Status : Completed
First Posted : June 20, 2012
Results First Posted : January 29, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE May 24, 2012
First Posted Date  ICMJE June 20, 2012
Results First Submitted Date  ICMJE December 21, 2015
Results First Posted Date  ICMJE January 29, 2016
Last Update Posted Date July 25, 2016
Study Start Date  ICMJE August 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2015)
Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) [ Time Frame: Baseline, Cycle1 Day 1, 8,15, 22, 29, and 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion ]
The corrected QT interval was calculated using Fridericia's correction (QTcF) from electrocardiogram (ECG) data. Each participant had triplicate QT intervals measured at each timepoint and the average was calculated for each participant at each timepoint. For each timepoint, a participant's corresponding baseline (Day -1, pretreatment) QTcF interval was subtracted from the average QTcF intervals to create the change from time-matched baseline in the QTcF interval
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2012)
Change from baseline in QT interval corrected for heart rate (QTc) [ Time Frame: Prior to first dose through Cycle 1 (6 weeks) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2015)
  • Change From Time-Matched Baseline ≥ 25% and Absolute Value of QRS >110 Msec (Electrocardiographic Parameters: QRS Interval) [ Time Frame: Baseline, Cycle1 Day 1, 8, 15, 22, 29, 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion ]
  • PR Change From Time-Matched Baseline ≥25% and Absolute Value of PR > 200 Msec (Electrocardiographic Parameters: PR Interval) [ Time Frame: Baseline, Cycle1 Day 1, 8, 15, 22, 29, 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion ]
  • Change From Time-Matched Baseline in Heart Rate (HR) (Electrocardiographic Parameters: Heart Rate [HR]) [ Time Frame: Baseline, Cycle1 Day 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion ]
    Change in HR from time-matched measures performed at baseline.
  • Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Necitumumab From Zero to Infinity (AUC[0-∞]) [ Time Frame: Cycle1 (Days 1 and 36): Pre-infusion, 50 minutes, 1.5, 2.5, 4.5, 24, 28, 72, and 168 hours ]
  • Pharmacokinetics: Maximum Drug Concentration (Cmax) of Necitumumab [ Time Frame: Cycle 1 (Days 1 and 36); Pre-infusion, 50 minutes, 1.5, 2.5, 4.5, 24, 28, 72, and 168 hours ]
  • Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) (Tumor Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 [RECIST 1.1]) [ Time Frame: Baseline to Measured Progressive Disease (up to 21 Months) ]
    ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1,CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100. PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD.
  • Number of Participants With an Incidence of Anti-Necitumumab Antibodies [ Time Frame: Baseline to Post Infusion 30 Day Follow-up ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2012)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Necitumumab Monotherapy and the QT/QTc Interval in Patient With Advanced Solid Tumors
Official Title  ICMJE A Study to Determine Whether Necitumumab (IMC-11F8) Monotherapy Affects the Corrected QT (QTc) Interval in Patients With Advanced Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors
Intervention  ICMJE Biological: Necitumumab
800 mg necitumumab, administered once per week IV
Other Names:
  • IMC-11F8
  • LY3012211
Study Arms  ICMJE Experimental: Necitumumab
800 mg necitumumab, administered once per week as an intravenous infusion (IV)
Intervention: Biological: Necitumumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2015)
75
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2012)
50
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01624467
Other Study ID Numbers  ICMJE 14472
CP11-1114 ( Other Identifier: ImClone Systems )
I4X-IE-JFCI ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Eli Lilly and Company
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eli Lilly and Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP