Trial Outcomes & Findings for Zalutumumab Pharmacokinetics (PK) in Squamous Cell Carcinoma of the Head and Neck (SCCHN) (NCT NCT01054625)
NCT ID: NCT01054625
Last Updated: 2023-08-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Pre-dose and post dose at multiple timepoints up to end of the study (up to 30 days)
Results posted on
2023-08-03
Participant Flow
Participant milestones
| Measure |
Zalutumumab 4 mg/kg
zalutumumab 4 mg/kg iv infusion
|
Zalutumumab 8 mg/kg
zalutumumab 8 mg/kg iv infusion
|
Zalutumumab 16 mg/kg
zalutumumab 16 mg/kg iv infusion
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
12
|
10
|
|
Overall Study
COMPLETED
|
6
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zalutumumab Pharmacokinetics (PK) in Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Baseline characteristics by cohort
| Measure |
Zalutumumab 4 mg/kg
n=8 Participants
zalutumumab 4 mg/kg iv infusion
|
Zalutumumab 8 mg/kg
n=12 Participants
zalutumumab 8 mg/kg iv infusion
|
Zalutumumab 16 mg/kg
n=10 Participants
zalutumumab 16 mg/kg iv infusion
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 8 • n=99 Participants
|
63 years
STANDARD_DEVIATION 11 • n=107 Participants
|
59 years
STANDARD_DEVIATION 5 • n=206 Participants
|
60 years
STANDARD_DEVIATION 9 • n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
|
Region of Enrollment
Hungary
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Region of Enrollment
Slovakia
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Region of Enrollment
Belgium
|
6 participants
n=99 Participants
|
7 participants
n=107 Participants
|
6 participants
n=206 Participants
|
19 participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
1 participants
n=206 Participants
|
5 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and post dose at multiple timepoints up to end of the study (up to 30 days)Population: PK parameter calculation for the fourth infusion was not performed for 3 participants: one participant \[8 mg/kg\] was withdrawn from treatment before infusion 4 and for two participants \[4 mg/kg, 8 mg/kg\] no infusion 4 was documented and only concentrations before dosing were reported. Overall number of participants analyzed are the number of participants with data available for analysis.
Outcome measures
| Measure |
Zalutumumab 4 mg/kg
n=7 Participants
zalutumumab 4 mg/kg iv infusion
|
Zalutumumab 8 mg/kg
n=10 Participants
zalutumumab 8 mg/kg iv infusion
|
Zalutumumab 16 mg/kg
n=10 Participants
zalutumumab 16 mg/kg iv infusion
|
|---|---|---|---|
|
Maximum Plasma Concentration of Zalutumumab After Fourth Infusion
|
104.3 mg/L
Geometric Coefficient of Variation 31
|
258.1 mg/L
Geometric Coefficient of Variation 28
|
494.3 mg/L
Geometric Coefficient of Variation 50
|
PRIMARY outcome
Timeframe: Pre-dose and post dose at multiple timepoints from start of first infusion up to end of last infusion (Day 0 to 7)Population: PK parameter calculation for the fourth infusion was not performed for 3 participants: one participant \[8 mg/kg\] was withdrawn from treatment before infusion 4 and for two participants \[4 mg/kg, 8 mg/kg\] no infusion 4 was documented and only concentrations before dosing were reported. Overall number of participants analyzed are the number of participants with data available for analysis.
Outcome measures
| Measure |
Zalutumumab 4 mg/kg
n=7 Participants
zalutumumab 4 mg/kg iv infusion
|
Zalutumumab 8 mg/kg
n=10 Participants
zalutumumab 8 mg/kg iv infusion
|
Zalutumumab 16 mg/kg
n=10 Participants
zalutumumab 16 mg/kg iv infusion
|
|---|---|---|---|
|
Area Under the Curve 0-7 Days
|
9308 h*mg/L
Geometric Coefficient of Variation 47
|
25091 h*mg/L
Geometric Coefficient of Variation 36
|
52158 h*mg/L
Geometric Coefficient of Variation 57
|
SECONDARY outcome
Timeframe: Pre-dose and post dose at multiple timepoints from start of fourth infusion up to end of last infusion (Day 0 to 21)Population: PK parameter calculation for the fourth infusion was not performed for 3 participants: one participant \[8 mg/kg\] was withdrawn from treatment before infusion 4 and for two participants \[4 mg/kg, 8 mg/kg\] no infusion 4 was documented and only concentrations before dosing were reported. Overall number of participants analyzed are the number of participants with data available for analysis.
Outcome measures
| Measure |
Zalutumumab 4 mg/kg
n=7 Participants
zalutumumab 4 mg/kg iv infusion
|
Zalutumumab 8 mg/kg
n=10 Participants
zalutumumab 8 mg/kg iv infusion
|
Zalutumumab 16 mg/kg
n=10 Participants
zalutumumab 16 mg/kg iv infusion
|
|---|---|---|---|
|
Area Under the Curve 0-21 Days
|
12728 h*mg/L
Geometric Coefficient of Variation 60.9
|
44275 h*mg/L
Geometric Coefficient of Variation 43.1
|
105960 h*mg/L
Geometric Coefficient of Variation 58.8
|
SECONDARY outcome
Timeframe: Pre-dose and post dose at multiple timepoints up to end of the study (up to 30 days)Population: PK parameter calculation for the fourth infusion was not performed for 3 participants: one participant \[8 mg/kg\] was withdrawn from treatment before infusion 4 and for two participants \[4 mg/kg, 8 mg/kg\] no infusion 4 was documented and only concentrations before dosing were reported. Overall number of participants analyzed are the number of participants with data available for analysis.
Outcome measures
| Measure |
Zalutumumab 4 mg/kg
n=7 Participants
zalutumumab 4 mg/kg iv infusion
|
Zalutumumab 8 mg/kg
n=10 Participants
zalutumumab 8 mg/kg iv infusion
|
Zalutumumab 16 mg/kg
n=10 Participants
zalutumumab 16 mg/kg iv infusion
|
|---|---|---|---|
|
Elimination Half-life
|
63 h
Geometric Coefficient of Variation 71.7
|
193 h
Geometric Coefficient of Variation 37.7
|
283 h
Geometric Coefficient of Variation 38.0
|
SECONDARY outcome
Timeframe: Pre-dose and post dose at multiple timepoints up to end of the study (up to 30 days)Population: PK parameter calculation for the fourth infusion was not performed for 3 participants: one participant \[8 mg/kg\] was withdrawn from treatment before infusion 4 and for two participants \[4 mg/kg, 8 mg/kg\] no infusion 4 was documented and only concentrations before dosing were reported. Overall number of participants analyzed are the number of participants with data available for analysis.
Outcome measures
| Measure |
Zalutumumab 4 mg/kg
n=7 Participants
zalutumumab 4 mg/kg iv infusion
|
Zalutumumab 8 mg/kg
n=10 Participants
zalutumumab 8 mg/kg iv infusion
|
Zalutumumab 16 mg/kg
n=10 Participants
zalutumumab 16 mg/kg iv infusion
|
|---|---|---|---|
|
Clearance
|
0.025 L/h
Geometric Coefficient of Variation 56.3
|
0.018 L/h
Geometric Coefficient of Variation 25.7
|
0.019 L/h
Geometric Coefficient of Variation 40.6
|
SECONDARY outcome
Timeframe: Pre-dose and post dose at multiple timepoints up to end of the study (up to 30 days)Population: PK parameter calculation for the fourth infusion was not performed for 3 participants: one participant \[8 mg/kg\] was withdrawn from treatment before infusion 4 and for two participants \[4 mg/kg, 8 mg/kg\] no infusion 4 was documented and only concentrations before dosing were reported. Overall number of participants analyzed are the number of participants with data available for analysis.
Outcome measures
| Measure |
Zalutumumab 4 mg/kg
n=7 Participants
zalutumumab 4 mg/kg iv infusion
|
Zalutumumab 8 mg/kg
n=10 Participants
zalutumumab 8 mg/kg iv infusion
|
Zalutumumab 16 mg/kg
n=10 Participants
zalutumumab 16 mg/kg iv infusion
|
|---|---|---|---|
|
Apparent Volume of Distribution During the Terminal Phase
|
2.28 L
Geometric Coefficient of Variation 49
|
4.99 L
Geometric Coefficient of Variation 35
|
7.83 L
Geometric Coefficient of Variation 56
|
SECONDARY outcome
Timeframe: Pre-dose and post dose at multiple timepoints up to end of the study (up to 30 days)Population: PK parameter calculation for the fourth infusion was not performed for 3 participants: one participant \[8 mg/kg\] was withdrawn from treatment before infusion 4 and for two participants \[4 mg/kg, 8 mg/kg\] no infusion 4 was documented and only concentrations before dosing were reported. Overall number of participants analyzed are the number of participants with data available for analysis.
Outcome measures
| Measure |
Zalutumumab 4 mg/kg
n=7 Participants
zalutumumab 4 mg/kg iv infusion
|
Zalutumumab 8 mg/kg
n=10 Participants
zalutumumab 8 mg/kg iv infusion
|
Zalutumumab 16 mg/kg
n=10 Participants
zalutumumab 16 mg/kg iv infusion
|
|---|---|---|---|
|
Apparent Volume of Distribution at Steady State
|
3.23 L
Geometric Coefficient of Variation 27
|
4.86 L
Geometric Coefficient of Variation 29
|
7.72 L
Geometric Coefficient of Variation 60
|
Adverse Events
Zalutumumab 4 mg/kg
Serious events: 7 serious events
Other events: 8 other events
Deaths: 0 deaths
Zalutumumab 8 mg/kg
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
Zalutumumab 16 mg/kg
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zalutumumab 4 mg/kg
n=8 participants at risk
zalutumumab 4 mg/kg iv infusion
|
Zalutumumab 8 mg/kg
n=12 participants at risk
zalutumumab 8 mg/kg iv infusion
|
Zalutumumab 16 mg/kg
n=10 participants at risk
zalutumumab 16 mg/kg iv infusion
|
|---|---|---|---|
|
General disorders
Disease progression
|
37.5%
3/8 • Number of events 3 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
33.3%
4/12 • Number of events 4 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
30.0%
3/10 • Number of events 3 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
General disorders
Infusion related reaction
|
25.0%
2/8 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/12 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
10.0%
1/10 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
General disorders
Pyrexia
|
12.5%
1/8 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/12 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Infections and infestations
Lung infection
|
0.00%
0/8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
8.3%
1/12 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/12 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/12 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
10.0%
1/10 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/12 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
10.0%
1/10 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
8.3%
1/12 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/12 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
10.0%
1/10 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
8.3%
1/12 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/12 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
10.0%
1/10 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Psychiatric disorders
Delirium
|
0.00%
0/8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
8.3%
1/12 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
8.3%
1/12 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
12.5%
1/8 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/12 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
Other adverse events
| Measure |
Zalutumumab 4 mg/kg
n=8 participants at risk
zalutumumab 4 mg/kg iv infusion
|
Zalutumumab 8 mg/kg
n=12 participants at risk
zalutumumab 8 mg/kg iv infusion
|
Zalutumumab 16 mg/kg
n=10 participants at risk
zalutumumab 16 mg/kg iv infusion
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
16.7%
2/12 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
30.0%
3/10 • Number of events 3 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/12 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
20.0%
2/10 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
8.3%
1/12 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
8.3%
1/12 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
20.0%
2/10 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
2/8 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
25.0%
3/12 • Number of events 3 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
20.0%
2/10 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
1/8 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/12 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
10.0%
1/10 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Gastrointestinal disorders
Dysphagia
|
37.5%
3/8 • Number of events 3 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
8.3%
1/12 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
10.0%
1/10 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
16.7%
2/12 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
8.3%
1/12 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
10.0%
1/10 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
1/8 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
8.3%
1/12 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
20.0%
2/10 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Gastrointestinal disorders
Oral pain
|
12.5%
1/8 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
8.3%
1/12 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
16.7%
2/12 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
10.0%
1/10 • Number of events 3 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
General disorders
Chills
|
25.0%
2/8 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
8.3%
1/12 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
General disorders
Fatigue
|
25.0%
2/8 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
41.7%
5/12 • Number of events 5 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
20.0%
2/10 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Gastrointestinal disorders
Mucosal inflammation
|
0.00%
0/8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/12 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
20.0%
2/10 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
General disorders
Pyrexia
|
25.0%
2/8 • Number of events 3 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
8.3%
1/12 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
20.0%
2/10 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Infections and infestations
Infection
|
12.5%
1/8 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/12 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
10.0%
1/10 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Investigations
Weight decreased
|
37.5%
3/8 • Number of events 3 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
8.3%
1/12 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
37.5%
3/8 • Number of events 3 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
33.3%
4/12 • Number of events 4 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
20.0%
2/10 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
1/8 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
16.7%
2/12 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
1/8 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
16.7%
2/12 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
10.0%
1/10 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
16.7%
2/12 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/12 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
20.0%
2/10 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
8.3%
1/12 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
20.0%
2/10 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
8.3%
1/12 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
20.0%
2/10 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
33.3%
4/12 • Number of events 5 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
20.0%
2/10 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Psychiatric disorders
Agitation
|
0.00%
0/8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
16.7%
2/12 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/12 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
20.0%
2/10 • Number of events 3 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
2/8 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
8.3%
1/12 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
20.0%
2/10 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
8.3%
1/12 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
10.0%
1/10 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
33.3%
4/12 • Number of events 4 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
20.0%
2/10 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
12.5%
1/8 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
8.3%
1/12 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
16.7%
2/12 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
50.0%
6/12 • Number of events 8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
60.0%
6/10 • Number of events 7 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
8.3%
1/12 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
0.00%
0/10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 60 days
|
Additional Information
Eva Järlid Westerberg, VP Clinical Operations
Genmab A/S
Phone: +45 7020 2728
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The site and the PI may be required to withhold the publication for up to 90 days. Subject to a reasoned request from the sponsor, the publication may be further delayed for a period up to 6 months from the date of first submission to the sponsor. The sponsor has the right to require deletion of any trade secret, proprietary, or confidential information supplied by the sponsor to the site or the PI. The sponsor shall not otherwise have the right to censor publications.
- Publication restrictions are in place
Restriction type: OTHER