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CompletedNCT00698841Updated Dec 24, 2015Results posted

Study to Evaluate the Effect of Cetuximab on Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors

A Phase 2 interventional study of Cetuximab in Advanced Cancer, sponsored by Eli Lilly and Company. Completed at 16 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-24.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
79
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Cancer

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 79 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
79 participants (actual)

Study arms

  • Experimental
    Cetuximab

    Drug: Cetuximab

Interventions

  • DrugCetuximab

    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.

    Also known as: Erbitux

06

What researchers measure

Primary outcomes

  1. Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline

    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.

    Time frame: Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)

  2. Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point

    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.

    Time frame: Predose Day 1 (Baseline) to end of Cycle 1 (28 days)

Secondary outcomes

  1. Number of Participants With Clinically Significant Changes in PR Interval, QRS Interval, and Heart Rate

    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.

    Time frame: Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)

  2. 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

    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.

    Time frame: Baseline through Cycle 1 (28 days), continuously

  3. Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade

    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.

    Time frame: Baseline through Cycle 1 (28 days), continuously

  4. Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study

    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.

    Time frame: At screening, at the end of Cycle 1 (28 days)

  5. Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued)

    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.

    Time frame: At screening, at the end of Cycle 1 (28 days)

  6. Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study

    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.

    Time frame: At screening, weekly prior to start of cetuximab infusion, at end of Cycle 1 (28 days), and at 30-day follow-up

07

Results

Posted May 11, 2011

Participant flow

Participant flow — Overall Study
MilestoneCetuximab
Started51
Completed33
Not completed18
Withdrew: Withdrawal by subject2
Withdrew: Adverse event3
Withdrew: Disease progression7
Withdrew: Failure to meet eligibility criteria2
Withdrew: Study drug toxicity2
Withdrew: Other2

Outcome measures

PrimaryNumber of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline

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.

Time frame:
Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)
Reported as:
Number · Participants
Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline
ParticipantsCetuximab
Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline0
SecondaryNumber of Participants With Clinically Significant Changes in PR Interval, QRS Interval, and Heart Rate

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.

Time frame:
Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)
Reported as:
Number · Participants
Number of Participants With Clinically Significant Changes in PR Interval, QRS Interval, and Heart Rate
ParticipantsCetuximab
Changes in PR interval0
Changes in QRS interval0
Changes in heart rate0
SecondaryNumber 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

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.

Time frame:
Baseline through Cycle 1 (28 days), continuously
Reported as:
Number · Participants
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
ParticipantsCetuximab
Deaths6
Treatment-related deaths0
SAEs16
Treatment-related SAEs2
AEs leading to discontinuation10
Treatment-related AEs leading to discontinuation3
SecondaryNumber of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade

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.

Time frame:
Baseline through Cycle 1 (28 days), continuously
Reported as:
Number · Participants
Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade
ParticipantsCetuximab
Infusion reaction (Any grade)6
Infusion reaction (Grade 3)2
Infusion reaction (Grade 4 or 5)0
Acneform rash (Any grade)32
Acneform rash (Grade 3)1
Acneform rash (Grade 4 or 5)0
Cardiac event (Any grade)2
Cardiac event (Grade 3)1
Cardiac event (Grade 4 or 5)0
Treatment-related infusion reaction (Any grade)6
Treatment-related infusion reaction (Grade 3)2
Treatment-related infusion reaction (Grade 4 or 5)0
Treatment-related acneform rash (Any grade)31
Treatment-related acneform rash (Grade 3)1
Treatment-related acneform rash (Grade 4 or 5)0
Treatment-related cardiac event (Any grade)0
Treatment-related cardiac event (Grade 3)0
Treatment-related cardiac event (Grade 4 or 5)0
SecondaryNumber of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study

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.

Time frame:
At screening, at the end of Cycle 1 (28 days)
Reported as:
Number · Participants
Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study
ParticipantsCetuximab
Albumin, low (BL, Grades 1-4) ( N=48)18
Albumin, low (OS, Grade 1-4) ( N=45)27
Albumin, low (BL, Grades 3 or 4) ( N=48)0
Albumin, low (OS, Grades 3 or 4) ( N=45)0
Albumin, low (BL, Grade 4) (N=48)0
Albumin, low (OS, Grade 4) (N=45)0
AST, high (BL, Grades 1-4) ( N=48)9
AST, high (OS, Grades 1- 4) ( N=45)19
AST, high (BL, Grades 3 or 4) ( N=48)1
AST, high (OS, Grades 3 or 4) ( N=45)2
AST, high (BL, Grade 4) ( N=48)0
AST, high (OS, Grade 4) ( N=45)0
Total bilirubin, high (BL, Grades 1-4) ( N=48)2
Total bilirubin, high (OS, Grades 1-4) ( N=45)4
Total bilirubin, high (BL, Grades 3 or 4) ( N=48)0
Total bilirubin, high (OS, Grades 3 or 4) (N=45)1
Total bilirubin, high (BL, Grade 4) ( N=48)0
Total bilirubin, high (OS, Grade 4) ( N=45)0
ALP, high (BL, Grade 1-4) ( N=48)18
ALP, high (OS, Grade 1-4) ( N=45)25
ALP, high (BL, Grade 3 or 4) ( N=48)1
ALP, high (OS, Grade 3 or 4) ( N=45)2
ALP, high (BL, Grade 4) ( N=48)0
ALP, high (OS, Grade 4) ( N=45)0
Creatinine, high (BL, Grades 1-4) ( N=48)1
Creatinine, high (OS, Grade 1-4) ( N=45)2
Creatinine, high (BL, Grades 3 or 4) ( N=48)0
Creatinine, high (OS, Grades 3 or 4) ( N=45)0
Creatinine, high (BL, Grade 4) ( N=48)0
Creatinine, high (OS, Grade 4) ( N=45)0
SecondaryNumber of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued)

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.

Time frame:
At screening, at the end of Cycle 1 (28 days)
Reported as:
Number · Participants
Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued)
ParticipantsCetuximab
Sodium, low (BL, Grades 1-4) ( N=48)0
Sodium, low (OS, Grades 1- 4) ( N=45)7
Sodium, low (BL, Grades 3 or 4) ( N=48)15
Sodium, low (OS, Grades 3 or 4) ( N=45)2
Sodium, low (BL, Grade 4) ( N=48)0
Sodium, low (OS, Grade 4) ( N=45)0
Sodium, high (BL, Grade 1-4) ( N=48)1
Sodium, high (OS, Grades 1-4) ( N=45)5
Sodium, high (BL, Grades 3 or 4) ( N=48)0
Sodium, high (OS, Grades 3 or 4) ( N=45)0
Sodium, high (BL, Grade 4) ( N=48)0
Sodium, high (OS, Grade 4) ( N=45)0
Potassium, high (BL, Grades 1-4) ( N=48)2
Potassium, high (OS, Grades 1-4) ( N=45)3
Potassium, high (BL, Grade 3 or 4) ( N=48)0
Potassium, high (OS, Grade 3 or 4) ( N=45)1
Potassium, high (BL, Grade 4) ( N=48)0
Potassium, high (OS, Grade 4) ( N=45)0
Glucose, low (BL, Grades 1- 4) ( N=48)0
Glucose, low (OS, Grades 1-4) ( N=45)2
Glucose, low (BL, Grades 3 or 4) ( N=48)0
Glucose, low (OS, Grades 3 or 4) ( N=45)0
Glucose, low (BL, Grade 4) ( N=48)0
Glucose, low (OS, Grade 4) ( N=45)0
Glucose, high (BL, Grades 1- 4) ( N=48)29
Glucose, high (OS, Grades 1- 4) ( N=45)37
Glucose, high (BL, Grades 3 or 4) (N=48)2
Glucose, high (OS, Grades 3 or 4) (N=45)4
Glucose, high (BL, Grade 4) (N=48)0
Glucose, high (OS, Grade 4) (N=45)0
Calcium, low (BL, Grade 1-4) (N=48)4
Calcium, low (OS, Grade 1-4) (N=45)14
Calcium, low (BL, Grade 3 or 4) (N=48)0
Calcium, low (OS, Grades 3 or 4) (N=45)0
Calcium, low (BL, Grade 4) (N=48)0
Calcium, low (OS, Grade 4) (N=45)0
Calcium, high (BL, Grades 1-4) (N=48)2
Calcium, high (OS, Grades 1-4) (N=45)2
Calcium, high (BL, Grades 3 or 4) (N=48)0
Calcium, high (OS, Grades 3 or 4) (N=45)0
Calcium, high (BL, Grade 4) (N=48)0
Calcium, high (OS, Grade 4) (N=45)0
Magnesium, low (BL, Grades 1-4) (N=41)3
Magnesium, low (OS, Grades 1-4) (N=38)11
Magnesium, low (BL, Grades 3 or 4) (N=41)0
Magnesium, low (OS, Grades 3 or 4) (N=38)1
Magnesium, low (BL, Grade 4) (N=41)0
Magnesium, low (OS, Grade 4) (N=38)1
PrimaryMean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point

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.

Time frame:
Predose Day 1 (Baseline) to end of Cycle 1 (28 days)
Reported as:
Mean · msec
Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point
msecCetuximab
Day 1 (N=36) Predose3.8 ± 2.5
Day 1 (N=37) 1 hour1.8 ± 1.9
Day 1 (N=37) 2 hour0.7 ± 2.1
Day 1 (N=36) 3 hour1.2 ± 1.6
Day 1 (N=37) 6 hour-2.4 ± 1.8
Day 8 (N=37) Predose1.3 ± 2.2
Day 8 (N=37) 1 hour1.9 ± 2.5
Day 8 (N=37) 2 hour4.5 ± 2.7
Day 8 (N=36) 3 hour0.8 ± 2.5
Day 15 (N=37) Predose3.2 ± 2.7
Day 15 (N=37) 1 hour2.6 ± 3.1
Day 15 (N=37) 2 hour1.2 ± 3.2
Day 15 (N=36) 3 hour-0.7 ± 3.6
Day 22 (N=37) Predose2.3 ± 3.3
Day 22 (N=37) 1 hour3.4 ± 2.9
Day 22 (N=37) 2 hour4.1 ± 3.2
Day 22 (N=36) 3 hour2.2 ± 2.8
Day 22 (N=37) 6 hour2.6 ± 2.4
Day 29 (N=30) Predose0.0 ± 3.4
Day 29 (N=30) 1 hour3.5 ± 2.9
Day 29 (N=30) 2 hour3.5 ± 2.7
Day 29 (N=29) 3 hour4.0 ± 3.0
SecondaryNumber of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study

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.

Time frame:
At screening, weekly prior to start of cetuximab infusion, at end of Cycle 1 (28 days), and at 30-day follow-up
Reported as:
Number · Participants
Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study
ParticipantsCetuximab
Hemoglobin, low (BL, Grades 1-4) (N=51)35
Hemoglobin, low (OS, Grades 1-4) (N=45)34
Hemoglobin, low (BL, Grades 3 or 4) (N=51)1
Hemoglobin, low (OS, Grades 3 or 4) (N=45)2
Hemoglobin, low (BL, Grade 4) (N=51)0
Hemoglobin, low (OS, Grade 4) (N=45)0
Platelets, low (BL, Grades 1-4) (N=51)8
Platelets, low (OS, Grades 1-4) (N=45)9
Platelets, low (BL, Grades 3 or 4) (N=51)0
Platelets, low (OS, Grades 3 or 4) (N=45)0
Platelets, low (BL, Grade 4) (N=51)0
Platelets, low (OS, Grade 4) (N=45)0
White blood cells, low (BL, Grades 1-4) (N=51)4
White blood cells, low (OS, Grades 1-4) (N=45)13
White blood cells, low (BL, Grades 3 or 4) (N=51)0
White blood cells, low (OS, Grades 3 or 4) (N=45)0
White blood cells, low (BL, Grade 4) (N=51)0
White blood cells, low (OS, Grade 4) (N=45)0
Neutrophils, low (BL, Grades 1-4) (N=47)0
Neutrophils, low (OS, Grades 1-4) (N=44)5
Neutrophils, low (BL, Grade 3 or 4) (N=47)0
Neutrophils, low (OS, Grade 3 or 4) (N=44)1
Neutrophils, low (BL, Grade 4) (N=47)0
Neutrophils, low (OS, Grade 4) (N=44)0

Adverse events

Collected over Baseline through Cycle 1 (28 days) and up to 30 following last dose of study medication (totaling up to 58 days). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cetuximab—16/51 (31.4%)43/51 (84.3%)
Most frequent serious events
Showing 10 of 21
Most frequent serious events
EventCetuximab
DISEASE PROGRESSIONGeneral disorders4/51
ACUTE CORONARY SYNDROMECardiac disorders1/51
HEADACHENervous system disorders1/51
ASCITESGastrointestinal disorders1/51
DISTAL INTESTINAL OBSTRUCTION SYNDROMEGastrointestinal disorders1/51
SEPSISInfections and infestations1/51
HYDRONEPHROSISRenal and urinary disorders1/51
INCISIONAL HERNIAInjury, poisoning and procedural complications1/51
JOINT DISLOCATIONInjury, poisoning and procedural complications1/51
NECK PAINMusculoskeletal and connective tissue disorders1/51
Most frequent other events
Showing 10 of 15
Most frequent other events
EventCetuximab
RASHSkin and subcutaneous tissue disorders22/51
HEADACHENervous system disorders11/51
DERMATITIS ACNEIFORMSkin and subcutaneous tissue disorders9/51
NAUSEAGastrointestinal disorders6/51
FATIGUEGeneral disorders5/51
VOMITINGGastrointestinal disorders4/51
DIARRHOEAGastrointestinal disorders4/51
ABDOMINAL PAINGastrointestinal disorders4/51
URINARY TRACT INFECTIONInfections and infestations4/51
PYREXIAGeneral disorders4/51

Baseline characteristics

Age, Continuous
Age, Continuous(years)Cetuximab
Mean61 ± 12
Sex: Female, Male
Sex: Female, Male(Participants)Cetuximab
Female21
Male30
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cetuximab
American Indian or Alaska Native0
Asian4
Native Hawaiian or Other Pacific Islander0
Black or African American1
White45
More than one race0
Unknown or Not Reported1
08

Study locations

16 sites
  • Northwest Alabama Cancer Center
    Muscle Shoals, Alabama 35661, United States
  • Donald W. Hill, MD
    Casa Grande, Arizona 85222, United States
  • Compassionate Cancer Care Medical Group, Inc
    Corona, California 92879, United States
  • Compassionate Cancer Care Medical Group Inc
    Fountain Valley, California 92708, United States
  • Pacific Shores Medical Group
    Long Beach, California 90813, United States
  • Desert Hospital Comprehensive Cancer Center
    Palm Springs, California 92262, United States
  • Compassionate Cancer Care Medical Group, Inc
    Riverside, California 92501, United States
  • American Institute Research
    Whittier, California 90603, United States
  • Georgetown University Medical Center
    Washington, District of Columbia 20007, United States
  • Baptist Cancer Institute
    Jacksonville, Florida 32207, United States
  • Ocala Oncology Center
    Ocala, Florida 34471, United States
  • Brinz, Burroff, Gurtler, & Russo
    Metairie, Louisiana 70006, United States
  • Cancer Specialists Of Oklahoma
    Oklahoma City, Oklahoma 73112, United States
  • Pharma Resource
    East Providence, Rhode Island 02915, United States
  • Austin Cancer Centers
    Austin, Texas 78759, United States
  • Local Institution
    San Juan, 00910, Puerto Rico
09

References and documents

Publications

  • Deeken JF, Shimkus B, Liem A, Hill D, Gurtler J, Berghorn E, Townes L, Lu H, Trifan O, Zhang S. Evaluation of the relationship between cetuximab therapy and corrected QT interval changes in patients with advanced malignancies from solid tumors. Cancer Chemother Pharmacol. 2013 Jun;71(6):1473-83. doi: 10.1007/s00280-013-2146-5. Epub 2013 Apr 16. PubMed 23589315 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00698841
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Jun 17, 2008
Start date
Feb 2009
Primary completion
Feb 2010
Completion
Feb 2010
Results posted
May 11, 2011
Last update
Dec 24, 2015

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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