- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00698841
Study to Evaluate the Effect of Cetuximab on Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors
November 24, 2015 updated by: Eli Lilly and Company
A Study to Evaluate the Relationship Between Cetuximab Therapy and Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors
The purpose of this study is to determine whether corrected QT (QTc) interval changes occur on an electrocardiogram (ECG) when cetuximab is administered to the study population.
Study Overview
Study Type
Interventional
Enrollment (Actual)
79
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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San Juan, Puerto Rico, 00910
- Local Institution
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Alabama
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Muscle Shoals, Alabama, United States, 35661
- Northwest Alabama Cancer Center
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Arizona
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Casa Grande, Arizona, United States, 85222
- Donald W. Hill, MD
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California
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Corona, California, United States, 92879
- Compassionate Cancer Care Medical Group, Inc
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Fountain Valley, California, United States, 92708
- Compassionate Cancer Care Medical Group Inc
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Long Beach, California, United States, 90813
- Pacific Shores Medical Group
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Palm Springs, California, United States, 92262
- Desert Hospital Comprehensive Cancer Center
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Riverside, California, United States, 92501
- Compassionate Cancer Care Medical Group, Inc
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Whittier, California, United States, 90603
- American Institute Research
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Georgetown University Medical Center
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Florida
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Jacksonville, Florida, United States, 32207
- Baptist Cancer Institute
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Ocala, Florida, United States, 34471
- Ocala Oncology Center
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Louisiana
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Metairie, Louisiana, United States, 70006
- Brinz, Burroff, Gurtler, & Russo
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
- Cancer Specialists Of Oklahoma
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Rhode Island
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East Providence, Rhode Island, United States, 02915
- Pharma Resource
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Texas
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Austin, Texas, United States, 78759
- Austin Cancer Centers
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Advanced or metastatic malignant disease originating from solid tumors
- Adequate recovery from previous therapy or intervention; at least 21 days since major surgery or prior radiation therapy
- Measurable or evaluable disease
Exclusion criteria:
- Women of childbearing potential (WOCBP) who are breastfeeding, pregnant, or unwilling or unable to use acceptable contraception during the study and for at least 12 weeks after the last on-study dose of cetuximab
- Men unwilling to use acceptable contraception during the study if engaged in sexual relations with a WOCBP
- Symptomatic brain metastasis
- History of myocardial infarction 6 months or less prior to study entry, of severe congestive heart failure, of uncontrolled angina, or of uncontrolled arrhythmias
- Clinically relevant abnormality on screening electrocardiogram (ECG), preventing an accurate measurement of the QT interval
- Congenital long QT syndrome
- History of risk factors for ventricular tachycardia or Torsades de pointes or history of fainting, unexplained loss of consciousness, or convulsions
- Prolonged QTc interval on screening ECG (greater than 470 msec) using Fridericia's correction formula
- Heart rate slower than 50 bpm or faster than 100 bpm at rest during screening ECG measurements
- Implantable pacemaker or automatic implantable cardioverter defibrillator
- Sustained supine systolic blood pressure higher than 150 mmHg or lower than 90 mmHg or a diastolic blood pressure lower than 45 mmHg or higher than 95 mmHg at screening
- Known history of arterial thrombotic events within 6 months prior to study initiation
- Known history of significant peripheral artery disease
- Current participation in a clinical trial with another investigational new drug or device
- Receipt of an investigational new drug or device within 21 days prior to enrollment in this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cetuximab
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Cetuximab administered by intravenous (IV) infusion at an initial dose of 400 mg/m^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m^2 over 60 minutes.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline
Time Frame: Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)
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12-Lead continuous digital electrocardiogram (ECG) data were collected at preselected time points at baseline visit and on Days 1, 8, 15, 22, and 29.
The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle.
The corrected QTc is the QT interval corrected for heart rate.
Prolongation of the QTc was identified as clinically meaningful at the investigator's discretion.
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Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)
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Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point
Time Frame: Predose Day 1 (Baseline) to end of Cycle 1 (28 days)
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The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle.
The QTc is the QT interval corrected for heart rate.
The QTcF=QT/RR^1/3, where RR=RR interval in seconds.
Baseline=predose.
Mean change in QTc interval from baseline to time t=QTc interval at time t minus QTc interval at baseline.
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Predose Day 1 (Baseline) to end of Cycle 1 (28 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Clinically Significant Changes in PR Interval, QRS Interval, and Heart Rate
Time Frame: Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)
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12-Lead continuous digital ECG data were collected at preselected time points at baseline visit and on Days 1, 8, 15, 22, and 29.
The PR interval is the time from the onset of the P wave to the beginning of the QRS complex.
The QRS interval=deflections in the ECG, comprising Q, R, and S waves, that represent depolarization of the ventricles.
Clinically significant was determined at the investigator's discretion.
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Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)
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Number of Participants With Death, Treatment-related Death, Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Treatment-related AEs Leading to Discontinuation
Time Frame: Baseline through Cycle 1 (28 days), continuously
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AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment.
SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event.
Treatment related=possibly, probably, or certainly related to or of unknown relationship to study treatment.
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Baseline through Cycle 1 (28 days), continuously
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Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade
Time Frame: Baseline through Cycle 1 (28 days), continuously
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AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment.
AEs of special interest have been sponsor-selected based on the known clinical effects of cetuximab.
Treatment related=possibly, probably, or certainly related to or of unknown relationship to study treatment.
CTC Grade 1: Mild.
Grade 2: Moderate.
Grade 3: Severe or medically significant but not immediately life-threatening.
Grade 4: Life-threatening.
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Baseline through Cycle 1 (28 days), continuously
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Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study
Time Frame: At screening, at the end of Cycle 1 (28 days)
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BL=baseline; OS=on-study; ULN=upper level of normal.
Albumin,low (g/dL) Grade 1:<LLN-30, Grade 2:<30-20, Grades 3&4:<20.
Aspartate aminotransferase (AST)(U/L) Grade 1:>ULN-2.5*ULN,
Grade 2:>2.5-5.0*ULN,
Grade 3:>5.0-20.0*ULN,
Grade 4:>20.0*ULN.
Total bilirubin, high Grade 1:ULN-1.5*ULN,
Grade 2:>1.5-3.0*ULN,
Grade 3:>3.0-10.0*ULN,
Grade 4:>10.0*ULN.
Alkaline phosphatase (ALP) (U/L) Grade 1:>ULN-2.5*ULN,
Grade 2:>2.5-5.0*ULN,
Grade 3:>5.0-20.0*ULN,
Grade 4:>20.0*ULN.
Creatinine (mg/dL) Grade 1:>ULN-1.5*ULN,
Grade 2:>1.5-3.0*ULN,
Grade 3:>3.0-6.0*ULN,
Grade 4:>6.0*ULN.
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At screening, at the end of Cycle 1 (28 days)
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Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued)
Time Frame: At screening, at the end of Cycle 1 (28 days)
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BL=baseline; OS=on-study; LLN=lower level of normal; ULN=upper level of normal.
Sodium, low(mmol/L) Grades 1&2:<LLN-130, Grade 3:<130-120, Grade 4:<120.
Sodium, high (mmol/L) Grade 1:>ULN-150, Grade 2:>150-155, Grade 3:>155-160, Grade 4:>160.
Potassium, high (mmol/L) Grade 1:>ULN-5.5,
Grade 2:>5.5-6.0,
Grade 3:>6.0-7.0,
Grade 4:>7.0.
Glucose, low(mg/dL) Grade 1:<LLN-55, Grade 2:<55-40, Grade 3:<40-30, Grade 4:<30.
Glucose, high (mg/dL) Grade 1:>ULN-160, Grade 2:>160-250, Grade 3:>250-500, Grade 4:>500.
Calcium, high(mg/dL) Grade 1:>ULN-11.5,
Grade 2:>11.5-12.5,
Grade 3:>12.5-13.5,
Grade 4:>13.
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At screening, at the end of Cycle 1 (28 days)
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Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study
Time Frame: At screening, weekly prior to start of cetuximab infusion, at end of Cycle 1 (28 days), and at 30-day follow-up
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BL=baseline; OS=on-study; LLN=lower level of normal.
Laboratory values assessed using CTC for AEs, Version 3.0.
Hemoglobin (g/dL) Grade 1:<LLN to 10.0, Grade 2:<10.0 to 8.0, Grade 3:<8.0 to 6.5, Grade 4:<6.5.
Platelets Grade 1:LLN to 75.0*10^9/L, Grade 2:<75.0 to 50.0*10^9/L, Grade 3:<50.0 to 25.0*10^9/L, Grade 4:<25.0 to 10^9/L.
White blood cells Grade 1:<LLN to 3.0*10^9/L, Grade 2:<3.0 to 2.0*10^9/L, Grade 3:<2.0 to 1.0*10^9/L, Grade 4:<1.0*10^9/L.
Neutrophils Grade 1:<LLN to 1.5*10^9/L, Grade 2:<1.5 to 1.0*10^9/L, Grade 3:<1.0 to 0.5*10^9/L, Grade 4:<0.5*10^9/L.
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At screening, weekly prior to start of cetuximab infusion, at end of Cycle 1 (28 days), and at 30-day follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
June 16, 2008
First Submitted That Met QC Criteria
June 16, 2008
First Posted (Estimate)
June 17, 2008
Study Record Updates
Last Update Posted (Estimate)
December 24, 2015
Last Update Submitted That Met QC Criteria
November 24, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA225-315
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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