Trial Outcomes & Findings for Study of Dalotuzumab (MK-0646) in Adults With Solid Tumors (MK-0646-009) (NCT NCT00694356)
NCT ID: NCT00694356
Last Updated: 2018-08-08
Results Overview
Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. DLTs were defined as the occurrence of any of the following events when judged to be related to the study medication: Grade 4 neutropenia; Grade 3 neutropenia with fever \>38.5°C; Grade 4 thrombocytopenia; Grade 3 or Grade 4 non-hematologic toxicity, except alopecia and inadequately treated diarrhea, nausea and vomiting. The number of participants who experienced a DLT is presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Cycle 1 (Up to 4 weeks)
Results posted on
2018-08-08
Participant Flow
Participant milestones
| Measure |
Dalotuzumab 5 mg/kg
Participants receive dalotuzumab 5 mg/kg by intravenous (IV) infusion once each week for up to 1 year or until participant withdraws consent, experiences an adverse event (AE), progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 10 mg/kg
Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 15 mg/kg/7.5 mg/kg
Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
6
|
Reasons for withdrawal
| Measure |
Dalotuzumab 5 mg/kg
Participants receive dalotuzumab 5 mg/kg by intravenous (IV) infusion once each week for up to 1 year or until participant withdraws consent, experiences an adverse event (AE), progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 10 mg/kg
Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 15 mg/kg/7.5 mg/kg
Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Progressive Disease
|
2
|
6
|
6
|
Baseline Characteristics
Study of Dalotuzumab (MK-0646) in Adults With Solid Tumors (MK-0646-009)
Baseline characteristics by cohort
| Measure |
Dalotuzumab 5 mg/kg
n=3 Participants
Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 10 mg/kg
n=6 Participants
Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 15 mg/kg/7.5 mg/kg
n=6 Participants
Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.3 Years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
63.5 Years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
59.2 Years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
62.3 Years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (Up to 4 weeks)Population: The population consisted of all participants who received at least one dose of study treatment.
Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. DLTs were defined as the occurrence of any of the following events when judged to be related to the study medication: Grade 4 neutropenia; Grade 3 neutropenia with fever \>38.5°C; Grade 4 thrombocytopenia; Grade 3 or Grade 4 non-hematologic toxicity, except alopecia and inadequately treated diarrhea, nausea and vomiting. The number of participants who experienced a DLT is presented.
Outcome measures
| Measure |
Dalotuzumab 5 mg/kg
n=3 Participants
Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 10 mg/kg
n=6 Participants
Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 15 mg/kg/7.5 mg/kg
n=6 Participants
Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
|---|---|---|---|
|
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after last dose of study treatment (Up to 101 days)Population: The population consisted of all participants who received at least one dose of study treatment.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.
Outcome measures
| Measure |
Dalotuzumab 5 mg/kg
n=3 Participants
Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 10 mg/kg
n=6 Participants
Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 15 mg/kg/7.5 mg/kg
n=6 Participants
Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
3 Participants
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 71 daysPopulation: The population consisted of all participants who received at least one dose of study treatment.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented.
Outcome measures
| Measure |
Dalotuzumab 5 mg/kg
n=3 Participants
Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 10 mg/kg
n=6 Participants
Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 15 mg/kg/7.5 mg/kg
n=6 Participants
Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an AE
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dosePopulation: The population consisted of all participants who had pharmacokinetic (PK) measurements at Baseline and at least once during treatment.
Cmax was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.
Outcome measures
| Measure |
Dalotuzumab 5 mg/kg
n=3 Participants
Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 10 mg/kg
n=6 Participants
Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 15 mg/kg/7.5 mg/kg
n=6 Participants
Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Dalotuzumab
|
85.60 µg/mL
Geometric Coefficient of Variation 6.94
|
161.78 µg/mL
Geometric Coefficient of Variation 23.02
|
244.05 µg/mL
Geometric Coefficient of Variation 11.57
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dosePopulation: The population consisted of all participants who had PK measurements at Baseline and at least once during treatment.
AUC0-∞ was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.
Outcome measures
| Measure |
Dalotuzumab 5 mg/kg
n=3 Participants
Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 10 mg/kg
n=6 Participants
Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 15 mg/kg/7.5 mg/kg
n=6 Participants
Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
|---|---|---|---|
|
Area Under the Concentration-Time Curve From Zero to Infinity (AUC0-∞) of Dalotuzumab
|
11.72 mg*h/mL
Geometric Coefficient of Variation 10.06 • Interval 1.0 to 1.0
|
21.71 mg*h/mL
Geometric Coefficient of Variation 37.64 • Interval 1.0 to 5.0
|
38.99 mg*h/mL
Geometric Coefficient of Variation 21.27 • Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dosePopulation: The population consisted of all participants who had PK measurements at Baseline and at least once during treatment.
Tmax was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.
Outcome measures
| Measure |
Dalotuzumab 5 mg/kg
n=3 Participants
Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 10 mg/kg
n=6 Participants
Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 15 mg/kg/7.5 mg/kg
n=6 Participants
Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
|---|---|---|---|
|
Time to Cmax (Tmax) of Dalotuzumab
|
1.0 h
Full Range 1.0 • Interval 1.0 to 1.0
|
3.0 h
Full Range 23.02 • Interval 1.0 to 5.0
|
1.0 h
Full Range 11.57 • Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dosePopulation: The population consisted of all participants who had PK measurements at Baseline and at least once during treatment.
t1/2 was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.
Outcome measures
| Measure |
Dalotuzumab 5 mg/kg
n=3 Participants
Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 10 mg/kg
n=6 Participants
Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 15 mg/kg/7.5 mg/kg
n=6 Participants
Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) of Dalotuzumab
|
129.85 h
Geometric Coefficient of Variation 12.44 • Interval 1.0 to 1.0
|
110.36 h
Geometric Coefficient of Variation 20.18 • Interval 1.0 to 5.0
|
167.09 h
Geometric Coefficient of Variation 20.94 • Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dosePopulation: The population consisted of all participants who had PK measurements at Baseline and at least once during treatment.
CL of dalotuzumab was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.
Outcome measures
| Measure |
Dalotuzumab 5 mg/kg
n=3 Participants
Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 10 mg/kg
n=6 Participants
Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 15 mg/kg/7.5 mg/kg
n=6 Participants
Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
|---|---|---|---|
|
Clearance (CL) of Dalotuzumab
|
0.0071 mL/min/kg
Geometric Coefficient of Variation 10.06
|
0.0077 mL/min/kg
Geometric Coefficient of Variation 37.64
|
0.0064 mL/min/kg
Geometric Coefficient of Variation 21.27
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dosePopulation: The population consisted of all participants who had PK measurements at Baseline and at least once during treatment.
Vss was assessed on Week 2 (Day 8) for the Dalotuzumab 5 mg/kg and Dalotuzumab 10 mg/kg treatment groups and on Week 3 (Day 15) for the Dalotuzumab 15 mg/kg/7.5 mg/kg treatment group.
Outcome measures
| Measure |
Dalotuzumab 5 mg/kg
n=3 Participants
Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 10 mg/kg
n=6 Participants
Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 15 mg/kg/7.5 mg/kg
n=6 Participants
Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
|---|---|---|---|
|
Steady State Volume of Distribution (Vss) of Dalotuzumab
|
0.0776 L/kg
Geometric Coefficient of Variation 17.46
|
0.0740 L/kg
Geometric Coefficient of Variation 24.10
|
0.0924 L/kg
Geometric Coefficient of Variation 16.74
|
SECONDARY outcome
Timeframe: Cycle 1: predose on Days 1, 8, 15, and 22; Cycles 2 and 3: predose on Day 1; 4 weeks after last dose of study drugPopulation: The population consisted of all participants who received at least one dose of study treatment.
Formation of HAHAs may block efficacy by substantially increasing the clearance of dalotuzumab and limit the possibility of future dalotuzumab therapy. The occurrence of HAHAs in the sera of dalotuzumab treated participants at any of the serum collection times was assessed.
Outcome measures
| Measure |
Dalotuzumab 5 mg/kg
n=3 Participants
Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 10 mg/kg
n=6 Participants
Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 15 mg/kg/7.5 mg/kg
n=6 Participants
Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
|---|---|---|---|
|
Number of Participants Who Developed a Human Anti-Humanized Antibody (HAHA) Response to Dalotuzumab
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Dalotuzumab 5 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dalotuzumab 10 mg/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Dalotuzumab 15 mg/kg/7.5 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dalotuzumab 5 mg/kg
n=3 participants at risk
Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 10 mg/kg
n=6 participants at risk
Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 15 mg/kg/7.5 mg/kg
n=6 participants at risk
Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Dalotuzumab 5 mg/kg
n=3 participants at risk
Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 10 mg/kg
n=6 participants at risk
Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
Dalotuzumab 15 mg/kg/7.5 mg/kg
n=6 participants at risk
Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 2 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gingival pain
|
33.3%
1/3 • Number of events 2 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
50.0%
3/6 • Number of events 3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
50.0%
3/6 • Number of events 3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Activated partial thromboplastin time shortened
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Blood glucose increased
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
66.7%
4/6 • Number of events 4 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Blood urine present
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
International normalised ratio decreased
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Prothrombin time shortened
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
50.0%
3/6 • Number of events 3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Investigations
White blood cell count decreased
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
50.0%
3/6 • Number of events 3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
66.7%
4/6 • Number of events 6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
66.7%
4/6 • Number of events 5 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
50.0%
3/6 • Number of events 3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Ketonuria
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
66.7%
2/3 • Number of events 2 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hot flush
|
33.3%
1/3 • Number of events 3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
0.00%
0/6 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
16.7%
1/6 • Number of events 1 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
33.3%
2/6 • Number of events 2 • Up to 30 days after last dose of study treatment (Up to 101 days)
The population consisted of all participants who received at least one dose of study treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER