Solid Tumors
Conditions
Keywords
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.
Interventions
BIOLOGICALNecitumumab
800 mg necitumumab, administered once per week IV
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PR Change From Time-Matched Baseline ≥25% and Absolute Value of PR > 200 Msec (Electrocardiographic Parameters: PR Interval) | 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]) | 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-∞]) | Cycle1 (Days 1 and 36): Pre-infusion, 50 minutes, 1.5, 2.5, 4.5, 24, 28, 72, and 168 hours | — |
| Change From Time-Matched Baseline ≥ 25% and Absolute Value of QRS >110 Msec (Electrocardiographic Parameters: QRS Interval) | 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 | — |
| 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]) | 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 | Baseline to Post Infusion 30 Day Follow-up | — |
| Pharmacokinetics: Maximum Drug Concentration (Cmax) of Necitumumab | Cycle 1 (Days 1 and 36); Pre-infusion, 50 minutes, 1.5, 2.5, 4.5, 24, 28, 72, and 168 hours | — |
Countries
United States
Participant flow
Pre-assignment details
Completers are defined as the QTc complete participants who received full doses of necitumumab for ≥1 full 6-week cycle or did not complete the first cycle because of QTc prolongation, and had pretreatment and post-infusion triplicate ECGs at the times specified in all versions of the protocol.
Participants by arm
| Arm | Count |
|---|---|
| Necitumumab 800 mg necitumumab, administered once per week IV | 75 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Per Sponsor Requirement | 1 |
| Overall Study | Progressive Disease | 19 |
| Overall Study | Subject Withdrew from Treatment | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Necitumumab |
|---|---|
| Age, Continuous | 60.3 years STANDARD_DEVIATION 9.92 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 63 Participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 75 / 75 |
| serious Total, serious adverse events | 33 / 75 |
Outcome results
Primary
Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc)
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
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
Population: QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, Day 1(D1), Pre-Infusion (n=74) | 1.00 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D1, End of Infusion (n=75) | 1.72 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D1, 1 hr Post-Infusion (n=75) | 0.63 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1,D1, 2 hr Post-Infusion (n=75) | -0.17 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1,D1, 4 hr Post-Infusion (n=75) | -2.02 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1,D1, 24 hr Post-Infusion (n=73) | -3.12 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1,D1, 48 hr Post-Infusion (n=73) | -2.67 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1,D1, 72 hr Post-Infusion (n=72) | -1.88 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D8, Pre-Infusion (n=72) | 5.19 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D8, End of Infusion (n=71) | 8.20 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1 D8, 1 hr Post-Infusion (n=70) | 5.34 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D8, 2 hr Post-Infusion (n=71) | 4.41 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D8, 4 hr Post-Infusion (n=72) | 3.42 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D15, Pre-Infusion (n=63) | 4.92 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D15, End of Infusion (n=63) | 6.47 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D15, 1 hr Post-Infusion (n=61) | 5.07 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D15, 2 hr Post-Infusion (n=62) | 4.04 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D15 4 hr Post-Infusion (n=62) | 3.04 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D22, Pre-Infusion (n=61) | 3.87 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D22, End of Infusion (n=59) | 6.89 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D22, 1 hr Post-Infusion (n=59) | 5.03 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D22, 2 hr Post-Infusion (n=60) | 2.48 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D22 4 hr Post-Infusion (n-60) | 1.53 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D29, Pre-Infusion (n=59) | 3.68 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D29, End of Infusion (n=59) | 6.95 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D29, 1 hr Post-Infusion (n=59) | 3.99 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D29, 2 hr Post-Infusion (n=59) | 3.25 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D29, 4 hr Post-Infusion (n=59) | 1.62 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D36, Pre-Infusion (n=53) | 4.47 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D36, End of Infusion (n=49) | 5.14 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D36, 1 hr Post-Infusion (n=50) | 3.59 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D36, 2 hr Post-Infusion (n-50) | 2.77 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D36, 4 hr Post-Infusion (n=49) | 1.15 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D36, 24 hr Post-Infusion (n=49) | -0.64 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D36, 48 hr Post-Infusion (n=50) | 0.09 milliseconds (msec) |
| Necitumumab | Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc) | Cycle 1, D36, 72 hr Post-Infusion (n=50) | -0.20 milliseconds (msec) |
Secondary
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
Population: QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Necitumumab | Change From Time-Matched Baseline ≥ 25% and Absolute Value of QRS >110 Msec (Electrocardiographic Parameters: QRS Interval) | 0 participants |
Secondary
Change From Time-Matched Baseline in Heart Rate (HR) (Electrocardiographic Parameters: Heart Rate [HR])
Change in HR from time-matched measures performed at baseline.
Time frame: Baseline, Cycle1 Day 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion
Population: QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Necitumumab | Change From Time-Matched Baseline in Heart Rate (HR) (Electrocardiographic Parameters: Heart Rate [HR]) | Cycle 1, D36, Pre-Infusion (n=53)) | 0.50 Beats/minute | Standard Deviation 10.22 |
| Necitumumab | Change From Time-Matched Baseline in Heart Rate (HR) (Electrocardiographic Parameters: Heart Rate [HR]) | Cycle 1, D36, End of Infusion, (n=49) | 1.92 Beats/minute | Standard Deviation 12.44 |
| Necitumumab | Change From Time-Matched Baseline in Heart Rate (HR) (Electrocardiographic Parameters: Heart Rate [HR]) | Cycle 1, D36, 1 hr Post-Infusion (n=50) | 2.73 Beats/minute | Standard Deviation 12.21 |
| Necitumumab | Change From Time-Matched Baseline in Heart Rate (HR) (Electrocardiographic Parameters: Heart Rate [HR]) | Cycle 1, D36, 2 hr Post-Infusion (n=50) | 2.02 Beats/minute | Standard Deviation 11.77 |
| Necitumumab | Change From Time-Matched Baseline in Heart Rate (HR) (Electrocardiographic Parameters: Heart Rate [HR]) | Cycle 1, D36, 4 hr Post-Infusion (n=49) | 3.36 Beats/minute | Standard Deviation 8.39 |
| Necitumumab | Change From Time-Matched Baseline in Heart Rate (HR) (Electrocardiographic Parameters: Heart Rate [HR]) | Cycle 1, D36, 24 hr Post-Infusion (n=49) | 3.56 Beats/minute | Standard Deviation 10.05 |
| Necitumumab | Change From Time-Matched Baseline in Heart Rate (HR) (Electrocardiographic Parameters: Heart Rate [HR]) | Cycle 1, D36, 48 hr Post-Infusion, (n=50) | 5.09 Beats/minute | Standard Deviation 10.55 |
| Necitumumab | Change From Time-Matched Baseline in Heart Rate (HR) (Electrocardiographic Parameters: Heart Rate [HR]) | Cycle 1, D36, 72 hr Post-Infusion (n=50) | 4.86 Beats/minute | Standard Deviation 12.36 |
| Necitumumab | Change From Time-Matched Baseline in Heart Rate (HR) (Electrocardiographic Parameters: Heart Rate [HR]) | Cycle 1, D36, 168 hr Post-Infusion (n=11) | 10.75 Beats/minute | Standard Deviation 15.77 |
Secondary
Number of Participants With an Incidence of Anti-Necitumumab Antibodies
Time frame: Baseline to Post Infusion 30 Day Follow-up
Population: All participants who received at least 1 dose of study drug and had at least 1 post-infusion blood sample.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Necitumumab | Number of Participants With an Incidence of Anti-Necitumumab Antibodies | Overall Antibody Positive | 9 participants |
| Necitumumab | Number of Participants With an Incidence of Anti-Necitumumab Antibodies | Overall Treatment Emergent Antibody Positive | 1 participants |
Secondary
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])
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.
Time frame: Baseline to Measured Progressive Disease (up to 21 Months)
Population: All participants who received any study drug and had CR or PR.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Necitumumab | 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]) | 2.7 percentage of participants |
Secondary
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
Population: All participants who received at least one dose of study drug and had evaluable PK parameters in Cycle 1, Days 1 and 36.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Necitumumab | Pharmacokinetics: Maximum Drug Concentration (Cmax) of Necitumumab | 270 microgram/milliliter (μg/mL) | Geometric Coefficient of Variation 27 |
| Necitumumab: Cycle 1, Day 36 | Pharmacokinetics: Maximum Drug Concentration (Cmax) of Necitumumab | 470 microgram/milliliter (μg/mL) | Geometric Coefficient of Variation 30 |
Secondary
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
Population: All participants who received at least one dose of study drug and had evaluable PK parameters in Cycle 1 on Days 1 and 36.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Necitumumab | Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Necitumumab From Zero to Infinity (AUC[0-∞]) | 24500 microgram*hour/milliliter (μg*h/ml) | Geometric Coefficient of Variation 34 |
| Necitumumab: Cycle 1, Day 36 | Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Necitumumab From Zero to Infinity (AUC[0-∞]) | 109000 microgram*hour/milliliter (μg*h/ml) | Geometric Coefficient of Variation 61 |
Secondary
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
Population: QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Necitumumab | PR Change From Time-Matched Baseline ≥25% and Absolute Value of PR > 200 Msec (Electrocardiographic Parameters: PR Interval) | 0 percentage of participants |