Trial Outcomes & Findings for A Study of Necitumumab Monotherapy and the QT/QTc Interval in Patient With Advanced Solid Tumors (NCT NCT01624467)
NCT ID: NCT01624467
Last Updated: 2016-07-25
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
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
Results posted on
2016-07-25
Participant Flow
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.
Participant milestones
| Measure |
Necitumumab
800 milligram (mg) necitumumab, administered once per week as an intravenous infusion (IV)
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
Received at Least One Dose of Study Drug
|
75
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
Necitumumab
800 milligram (mg) necitumumab, administered once per week as an intravenous infusion (IV)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Progressive Disease
|
19
|
|
Overall Study
Per Sponsor Requirement
|
1
|
|
Overall Study
Subject Withdrew from Treatment
|
1
|
Baseline Characteristics
A Study of Necitumumab Monotherapy and the QT/QTc Interval in Patient With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Necitumumab
n=75 Participants
800 mg necitumumab, administered once per week IV
|
|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 9.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 InfusionPopulation: QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG.
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
Outcome measures
| Measure |
Necitumumab
n=75 Participants
800 mg necitumumab, administered once per week IV
|
Necitumumab: Cycle 1, Day 36
800 mg necitumumab, administered once per week IV
|
|---|---|---|
|
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)
Interval -0.44 to 2.44
|
—
|
|
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)
Interval 0.17 to 3.28
|
—
|
|
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)
Interval -1.2 to 2.36
|
—
|
|
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)
Interval -1.84 to 1.51
|
—
|
|
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)
Interval -3.81 to -0.24
|
—
|
|
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)
Interval -4.74 to -1.5
|
—
|
|
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)
Interval -4.44 to -0.91
|
—
|
|
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)
Interval -3.87 to 0.11
|
—
|
|
Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc)
Cycle 1, D8, Pre-Infusion (n=72)
|
5.19 milliseconds (msec)
Interval 2.86 to 7.52
|
—
|
|
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)
Interval 5.93 to 10.47
|
—
|
|
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)
Interval 3.12 to 7.57
|
—
|
|
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)
Interval 2.41 to 6.4
|
—
|
|
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)
Interval 1.45 to 5.38
|
—
|
|
Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc)
Cycle 1, D15, Pre-Infusion (n=63)
|
4.92 milliseconds (msec)
Interval 2.49 to 7.52
|
—
|
|
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)
Interval 4.07 to 8.88
|
—
|
|
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)
Interval 2.57 to 7.58
|
—
|
|
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)
Interval 1.13 to 6.95
|
—
|
|
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)
Interval 0.44 to 5.63
|
—
|
|
Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc)
Cycle 1, D22, Pre-Infusion (n=61)
|
3.87 milliseconds (msec)
Interval 1.79 to 5.96
|
—
|
|
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)
Interval 4.47 to 9.31
|
—
|
|
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)
Interval 2.56 to 7.5
|
—
|
|
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)
Interval 0.27 to 4.69
|
—
|
|
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)
Interval -0.66 to 3.72
|
—
|
|
Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc)
Cycle 1, D29, Pre-Infusion (n=59)
|
3.68 milliseconds (msec)
Interval 1.38 to 5.98
|
—
|
|
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)
Interval 4.74 to 9.16
|
—
|
|
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)
Interval 1.54 to 6.44
|
—
|
|
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)
Interval 1.01 to 5.48
|
—
|
|
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)
Interval -0.4 to 3.64
|
—
|
|
Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc)
Cycle 1, D36, Pre-Infusion (n=53)
|
4.47 milliseconds (msec)
Interval 2.11 to 6.84
|
—
|
|
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)
Interval 2.94 to 7.34
|
—
|
|
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)
Interval 0.82 to 6.36
|
—
|
|
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)
Interval 0.25 to 5.29
|
—
|
|
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)
Interval -1.11 to 3.4
|
—
|
|
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)
Interval -2.83 to 1.55
|
—
|
|
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)
Interval -2.75 to 2.93
|
—
|
|
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)
Interval -2.51 to 2.12
|
—
|
SECONDARY outcome
Timeframe: Baseline, Cycle1 Day 1, 8, 15, 22, 29, 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post InfusionPopulation: QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG
Outcome measures
| Measure |
Necitumumab
n=75 Participants
800 mg necitumumab, administered once per week IV
|
Necitumumab: Cycle 1, Day 36
800 mg necitumumab, administered once per week IV
|
|---|---|---|
|
Change From Time-Matched Baseline ≥ 25% and Absolute Value of QRS >110 Msec (Electrocardiographic Parameters: QRS Interval)
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Cycle1 Day 1, 8, 15, 22, 29, 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post InfusionPopulation: QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG.
Outcome measures
| Measure |
Necitumumab
n=75 Participants
800 mg necitumumab, administered once per week IV
|
Necitumumab: Cycle 1, Day 36
800 mg necitumumab, administered once per week IV
|
|---|---|---|
|
PR Change From Time-Matched Baseline ≥25% and Absolute Value of PR > 200 Msec (Electrocardiographic Parameters: PR Interval)
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Cycle1 Day 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post InfusionPopulation: QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG
Change in HR from time-matched measures performed at baseline.
Outcome measures
| Measure |
Necitumumab
n=75 Participants
800 mg necitumumab, administered once per week IV
|
Necitumumab: Cycle 1, Day 36
800 mg necitumumab, administered once per week IV
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 outcome
Timeframe: Cycle1 (Days 1 and 36): Pre-infusion, 50 minutes, 1.5, 2.5, 4.5, 24, 28, 72, and 168 hoursPopulation: All participants who received at least one dose of study drug and had evaluable PK parameters in Cycle 1 on Days 1 and 36.
Outcome measures
| Measure |
Necitumumab
n=18 Participants
800 mg necitumumab, administered once per week IV
|
Necitumumab: Cycle 1, Day 36
n=11 Participants
800 mg necitumumab, administered once per week IV
|
|---|---|---|
|
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
|
109000 microgram*hour/milliliter (μg*h/ml)
Geometric Coefficient of Variation 61
|
SECONDARY outcome
Timeframe: Cycle 1 (Days 1 and 36); Pre-infusion, 50 minutes, 1.5, 2.5, 4.5, 24, 28, 72, and 168 hoursPopulation: All participants who received at least one dose of study drug and had evaluable PK parameters in Cycle 1, Days 1 and 36.
Outcome measures
| Measure |
Necitumumab
n=71 Participants
800 mg necitumumab, administered once per week IV
|
Necitumumab: Cycle 1, Day 36
n=49 Participants
800 mg necitumumab, administered once per week IV
|
|---|---|---|
|
Pharmacokinetics: Maximum Drug Concentration (Cmax) of Necitumumab
|
270 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 27
|
470 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 30
|
SECONDARY outcome
Timeframe: Baseline to Measured Progressive Disease (up to 21 Months)Population: All participants who received any study drug and had CR or PR.
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.
Outcome measures
| Measure |
Necitumumab
n=75 Participants
800 mg necitumumab, administered once per week IV
|
Necitumumab: Cycle 1, Day 36
800 mg necitumumab, administered once per week IV
|
|---|---|---|
|
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
Interval 0.3 to 9.3
|
—
|
SECONDARY outcome
Timeframe: Baseline to Post Infusion 30 Day Follow-upPopulation: All participants who received at least 1 dose of study drug and had at least 1 post-infusion blood sample.
Outcome measures
| Measure |
Necitumumab
n=75 Participants
800 mg necitumumab, administered once per week IV
|
Necitumumab: Cycle 1, Day 36
800 mg necitumumab, administered once per week IV
|
|---|---|---|
|
Number of Participants With an Incidence of Anti-Necitumumab Antibodies
Overall Antibody Positive
|
9 participants
|
—
|
|
Number of Participants With an Incidence of Anti-Necitumumab Antibodies
Overall Treatment Emergent Antibody Positive
|
1 participants
|
—
|
Adverse Events
Necitumumab
Serious events: 33 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Necitumumab
n=75 participants at risk
800 mg necitumumab, administered once per week as an intravenous infusion (IV)
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/75 • Number of events 2
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Epiploic appendagitis
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.3%
4/75 • Number of events 6
All participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
General disorders
Disease recurrence
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Anaphylactic reaction
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Infection
|
1.3%
1/75 • Number of events 2
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Klebsiella bacteraemia
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Lung infection
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Meningitis aseptic
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
2.7%
2/75 • Number of events 2
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.7%
2/75 • Number of events 2
All participants who received at least 1 dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Investigations
Lipase increased
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
8.0%
6/75 • Number of events 6
All participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
2.7%
2/75 • Number of events 2
All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
3/75 • Number of events 3
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
5.3%
4/75 • Number of events 4
All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
1.3%
1/75 • Number of events 1
All participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Necitumumab
n=75 participants at risk
800 mg necitumumab, administered once per week as an intravenous infusion (IV)
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
38.7%
29/75 • Number of events 43
All participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
5.3%
4/75 • Number of events 4
All participants who received at least 1 dose of study drug.
|
|
Eye disorders
Vision blurred
|
8.0%
6/75 • Number of events 7
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.3%
7/75 • Number of events 8
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
18.7%
14/75 • Number of events 15
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.3%
19/75 • Number of events 32
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
42.7%
32/75 • Number of events 42
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
9.3%
7/75 • Number of events 8
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
28.0%
21/75 • Number of events 25
All participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
8.0%
6/75 • Number of events 6
All participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
13.3%
10/75 • Number of events 11
All participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
37.3%
28/75 • Number of events 33
All participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
9.3%
7/75 • Number of events 8
All participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
18.7%
14/75 • Number of events 16
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
8.0%
6/75 • Number of events 7
All participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
8.0%
6/75 • Number of events 12
All participants who received at least 1 dose of study drug.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.3%
4/75 • Number of events 9
All participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
9.3%
7/75 • Number of events 8
All participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
18.7%
14/75 • Number of events 15
All participants who received at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
18.7%
14/75 • Number of events 19
All participants who received at least 1 dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
5.3%
4/75 • Number of events 4
All participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
10.7%
8/75 • Number of events 13
All participants who received at least 1 dose of study drug.
|
|
Investigations
Electrocardiogram qt prolonged
|
34.7%
26/75 • Number of events 61
All participants who received at least 1 dose of study drug.
|
|
Investigations
International normalised ratio increased
|
5.3%
4/75 • Number of events 5
All participants who received at least 1 dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
28.0%
21/75 • Number of events 59
All participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
9.3%
7/75 • Number of events 9
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.0%
21/75 • Number of events 22
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
5/75 • Number of events 7
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
18.7%
14/75 • Number of events 44
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
9.3%
7/75 • Number of events 8
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
28.0%
21/75 • Number of events 34
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.0%
6/75 • Number of events 6
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
24.0%
18/75 • Number of events 22
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
34.7%
26/75 • Number of events 55
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.3%
7/75 • Number of events 7
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.3%
7/75 • Number of events 7
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
9/75 • Number of events 10
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.3%
4/75 • Number of events 4
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.3%
4/75 • Number of events 4
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.0%
6/75 • Number of events 7
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
14.7%
11/75 • Number of events 11
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
6.7%
5/75 • Number of events 9
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
58.7%
44/75 • Number of events 55
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.3%
4/75 • Number of events 6
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
10.7%
8/75 • Number of events 10
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
12.0%
9/75 • Number of events 11
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.0%
12/75 • Number of events 14
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.7%
8/75 • Number of events 8
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
5/75 • Number of events 5
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.7%
8/75 • Number of events 8
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.0%
6/75 • Number of events 7
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
33.3%
25/75 • Number of events 32
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
22.7%
17/75 • Number of events 20
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
12.0%
9/75 • Number of events 12
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.7%
11/75 • Number of events 11
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
41.3%
31/75 • Number of events 48
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.3%
7/75 • Number of events 8
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
8.0%
6/75 • Number of events 7
All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Flushing
|
6.7%
5/75 • Number of events 5
All participants who received at least 1 dose of study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60