Study to Evaluate the Effect of Cetuximab on Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors
- Registration Number
- NCT00698841
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cetuximab Cetuximab -
- Primary Outcome Measures
Name Time Method Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline Baseline, Day 1, and then weekly to end of Cycle 1 (28 days) 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.
Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point Predose Day 1 (Baseline) to end of Cycle 1 (28 days) 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.
- Secondary Outcome Measures
Name Time Method 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 Baseline through Cycle 1 (28 days), continuously 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.
Number of Participants With Clinically Significant Changes in PR Interval, QRS Interval, and Heart Rate Baseline, Day 1, and then weekly to end of Cycle 1 (28 days) 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.
Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study At screening, at the end of Cycle 1 (28 days) 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.
Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade Baseline through Cycle 1 (28 days), continuously 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.
Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued) At screening, at the end of Cycle 1 (28 days) 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.
Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study At screening, weekly prior to start of cetuximab infusion, at end of Cycle 1 (28 days), and at 30-day follow-up 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.
Trial Locations
- Locations (15)
Local Institution
🇵🇷San Juan, Puerto Rico
Cancer Specialists Of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
Baptist Cancer Institute
🇺🇸Jacksonville, Florida, United States
Brinz, Burroff, Gurtler, & Russo
🇺🇸Metairie, Louisiana, United States
Pharma Resource
🇺🇸East Providence, Rhode Island, United States
Donald W. Hill, MD
🇺🇸Casa Grande, Arizona, United States
Northwest Alabama Cancer Center
🇺🇸Muscle Shoals, Alabama, United States
Compassionate Cancer Care Medical Group Inc
🇺🇸Fountain Valley, California, United States
Compassionate Cancer Care Medical Group, Inc
🇺🇸Riverside, California, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
Desert Hospital Comprehensive Cancer Center
🇺🇸Palm Springs, California, United States
American Institute Research
🇺🇸Whittier, California, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Austin Cancer Centers
🇺🇸Austin, Texas, United States