Trial Outcomes & Findings for A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia (NCT NCT00586924)
NCT ID: NCT00586924
Last Updated: 2019-04-02
Results Overview
Adverse events are suspected of causal relationship to drug and are \>=Grade (G) 3 in severity considered DLTs: G 3 or 4 hematologic abnormalities at baseline due to disease were not evaluable for hematologic DLT, G 2 allergic reactions of bronchospasm or urticaria, or any \>= G3 allergic reaction, in presence of pre-medication were considered DLTs. Following \>= G 3 non-hematological treatment-related toxicities not considered DLTs: Tumor lysis syndrome, G 3 low electrolyte levels with pre-existing low levels of same electrolytes, anticoagulant therapy, G 3 or 4 infection or neutropenic fever unless relationship to IP is suspected, G 3 transaminase, alkaline phosphatase, bilirubin or other liver function test elevation provided resolution to values required for study entry prior to start of next cycle, G 3 fever, G 3 hypertriglyceridemia and hypercholesterolemia, and G 4 hypertriglyceridemia lasting \<2 months, G 3 hypoalbuminemia lasting \<7 days occurred in absence of CLS.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
49 participants
Primary outcome timeframe
Cycle 1 Day 1 to Cycle 2 Day 10 (each cycle duration was 28 days)
Results posted on
2019-04-02
Participant Flow
Participant milestones
| Measure |
5 mcg/kg
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
20 mcg/kg
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
4
|
33
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
3
|
4
|
33
|
Reasons for withdrawal
| Measure |
5 mcg/kg
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
20 mcg/kg
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse event/serious adverse event
|
0
|
0
|
0
|
1
|
0
|
2
|
|
Overall Study
Initiation of alternative cancer therapy
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Disease progression
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Development of neutralizing antibodies
|
2
|
2
|
2
|
0
|
0
|
22
|
|
Overall Study
Complete response
|
0
|
1
|
0
|
0
|
2
|
2
|
|
Overall Study
Other
|
1
|
0
|
1
|
1
|
1
|
6
|
Baseline Characteristics
A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia
Baseline characteristics by cohort
| Measure |
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=3 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=33 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
Years
|
56.3 Years
STANDARD_DEVIATION 14.2 • n=39 Participants
|
54.3 Years
STANDARD_DEVIATION 6.1 • n=41 Participants
|
56.3 Years
STANDARD_DEVIATION 3.1 • n=35 Participants
|
58.3 Years
STANDARD_DEVIATION 4.0 • n=31 Participants
|
61.8 Years
STANDARD_DEVIATION 11.1 • n=146 Participants
|
55.8 Years
STANDARD_DEVIATION 9.0 • n=19 Participants
|
56.4 Years
STANDARD_DEVIATION 8.7 • n=147 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
5 Participants
n=19 Participants
|
8 Participants
n=147 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
28 Participants
n=19 Participants
|
41 Participants
n=147 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 to Cycle 2 Day 10 (each cycle duration was 28 days)Population: Evaluable population for DLT included all participants who received any treatment of moxetumomab pasudotox, completed at least Cycle 2 Day 10, or discontinued treatment due to a DLT on or before Cycle 2 Day 10.
Adverse events are suspected of causal relationship to drug and are \>=Grade (G) 3 in severity considered DLTs: G 3 or 4 hematologic abnormalities at baseline due to disease were not evaluable for hematologic DLT, G 2 allergic reactions of bronchospasm or urticaria, or any \>= G3 allergic reaction, in presence of pre-medication were considered DLTs. Following \>= G 3 non-hematological treatment-related toxicities not considered DLTs: Tumor lysis syndrome, G 3 low electrolyte levels with pre-existing low levels of same electrolytes, anticoagulant therapy, G 3 or 4 infection or neutropenic fever unless relationship to IP is suspected, G 3 transaminase, alkaline phosphatase, bilirubin or other liver function test elevation provided resolution to values required for study entry prior to start of next cycle, G 3 fever, G 3 hypertriglyceridemia and hypercholesterolemia, and G 4 hypertriglyceridemia lasting \<2 months, G 3 hypoalbuminemia lasting \<7 days occurred in absence of CLS.
Outcome measures
| Measure |
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=3 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=3 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=3 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)Population: Safety population included all participants who received any treatment of moxetumomab pasudotox.
The TEAEs are defined as adverse events (AEs) present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug, for the period extending to 30 days after the last dose of study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received moxetumomab pasudotox.
Outcome measures
| Measure |
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=3 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=33 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TEAEs
|
3 Participants
|
3 Participants
|
4 Participants
|
33 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
TESAEs
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)Population: Safety population included all participants who received any treatment of moxetumomab pasudotox.
Vital signs abnormalities reported as TEAEs included pyrexia, weight increased, dyspnoea, hypoxia, hypertension, hypotension.
Outcome measures
| Measure |
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=3 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=33 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hypertension
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Pyrexia
|
2 Participants
|
3 Participants
|
1 Participants
|
16 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Weight increased
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Dyspnoea
|
0 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hypoxia
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hypotension
|
0 Participants
|
2 Participants
|
0 Participants
|
10 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)Population: Safety population included all participants who received any treatment of moxetumomab pasudotox.
Cardiac AEs observed in participants with clinically significant ECG abnormalities included; ECG QT prolonged, Sinus tachycardia and Atrioventricular block first degree.
Outcome measures
| Measure |
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=3 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=33 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)
ECG QT prolonged
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)
Sinus tachycardia
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)
Atrioventricular block first degree
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)Population: Safety population included all participants who received any treatment of moxetumomab pasudotox.
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event.
Outcome measures
| Measure |
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=3 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=33 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Blood bilirubin increased
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Blood creatine phosphokinase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Blood creatinine increased
|
0 Participants
|
1 Participants
|
0 Participants
|
11 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Blood triglycerides increased
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Gamma-glutamyltransferase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Blood uric acid increased
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hyperglycaemia
|
0 Participants
|
2 Participants
|
2 Participants
|
13 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hypermagnesaemia
|
0 Participants
|
0 Participants
|
1 Participants
|
12 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Haptoglobin decreased
|
0 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Alanine aminotransferase increased
|
1 Participants
|
3 Participants
|
2 Participants
|
25 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Blood bicarbonate decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Aspartate aminotransferase increased
|
1 Participants
|
2 Participants
|
1 Participants
|
24 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Blood alkaline phosphatase increased
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hypernatraemia
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hypertriglyceridaemia
|
1 Participants
|
0 Participants
|
0 Participants
|
19 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hyperuricaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hypoalbuminaemia
|
1 Participants
|
3 Participants
|
3 Participants
|
25 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hypocalcaemia
|
0 Participants
|
1 Participants
|
1 Participants
|
11 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hypoglycaemia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hypokalaemia
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hypomagnesaemia
|
1 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hyponatraemia
|
0 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hypophosphataemia
|
0 Participants
|
1 Participants
|
0 Participants
|
10 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hemoglobin urine
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Protein urine
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Proteinuria
|
0 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hemoglobinuria
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hypercholesterolaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hyperkalaemia
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Lymphopenia
|
2 Participants
|
0 Participants
|
0 Participants
|
25 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
White blood cell count decresed
|
2 Participants
|
1 Participants
|
2 Participants
|
17 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Lymphocyte count decreased
|
1 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Neutrophil count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
10 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Hemoglobin decreased
|
2 Participants
|
1 Participants
|
1 Participants
|
9 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Platelet count decreased
|
0 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)Population: Safety population included all participants who received any treatment of moxetumomab pasudotox.
Objective response rate defined as proportion of participants with confirmed CR or confirmed PR according to Response Evaluation Criteria for hairy cell leukemia (HCL). A CR is defined as: No evidence of leukemic cells by routine H/E stains of peripheral blood and bone marrow. No hepatomegaly, splenomegaly, or lymphadenopathy by physical examination and/or appropriate radiographic techniques. Normal complete blood count as: Neutrophils \>= 1,500/mcL, Platelets \>= 100,000/mcL, and Hemoglobin \>= 11.0 gm/dL without transfusions or growth factors for at least 4 weeks. Partial response requires all of following: \>=50% reduction in peripheral blood lymphocyte from pretreatment baseline value, lymphadenopathy, and abnormal hepatosplenomegaly by CT scan or physical exam, and complete blood count as Neutrophils \>= 1,500/mcL, Platelets \>=100,000/mcL, and Hemoglobin \>= 11.0 g/dL or 50% improvement of all parameters over baseline without transfusions or growth factors for at least 4 weeks.
Outcome measures
| Measure |
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=3 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=33 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Objective Response Rate (ORR): Complete Response (CR) or Partial Response (PR)
|
2 Participants
|
2 Participants
|
3 Participants
|
29 Participants
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)Population: Safety population included all participants who received any treatment of moxetumomab pasudotox.
The CR is defined by: No evidence of leukemic cells by routine H/E stains of the peripheral blood and bone marrow. No hepatomegaly, splenomegaly, or lymphadenopathy by physical examination and/or appropriate radiographic techniques. Normal complete blood count as exhibited by: Neutrophils \>= 1,500/microliter (mcL), Platelets \>= 100,000/mcL, and Hemoglobin \>= 11.0 gram per deciliter (gm/dL) without transfusions or growth factors for at least 4 weeks.
Outcome measures
| Measure |
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=3 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=33 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Complete Response (CR)
|
2 Participants
|
1 Participants
|
2 Participants
|
21 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)Population: Safety population included all participants who received any treatment of moxetumomab pasudotox.
Partial response requires all of the following: \>=50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value, \>=50% reduction in lymphadenopathy, \>=50% reduction in abnormal hepatosplenomegaly by computed tomography or physical exam, Neutrophils \>= 1,500/mcL or 50% improvement over baseline without growth factors for at least 4 weeks, Platelets \>=100,000/mcL or 50% improvement over baseline, and Hemoglobin \>= 11.0 g/dL or 50% improvement over baseline without transfusions or growth factors for at least 4 weeks. For participants who are transfusion-dependent at baseline, a hemoglobin of \>= 9.0 g/dL without transfusions or growth factors for at least 4 weeks.
Outcome measures
| Measure |
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=3 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=33 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Partial Response (PR)
|
0 Participants
|
1 Participants
|
1 Participants
|
8 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)Population: Safety population included all participants who received any treatment of moxetumomab pasudotox.
Stable disease was characterized by not meeting the criteria for CR, PR or PD.
Outcome measures
| Measure |
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=3 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=33 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Stable Disease (SD)
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)Population: Safety population included all participants who received any treatment of moxetumomab pasudotox.
Progressive disease is defined by at least one of the following compared to pretreatment:\>= 25% increase in the sum of the products of the greatest perpendicular dimensions of at least two lymph nodes on two consecutive examinations at least 2 weeks apart (at least 1 node must be \>= 2 cm) or appearance of new palpable lymph nodes, \>=25% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin, or appearance of new palpable hepatomegaly or splenomegaly that was not previously present, \>=50% increase in the absolute number of circulating lymphocytes, \>=25% decrease in hemoglobin (must be \< 11g/dL), platelets (must be \< 100,000/mcL), or absolute neutrophil count (must be \< 1500/mcL) unless these are judged to be effects of treatment.
Outcome measures
| Measure |
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=3 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=33 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Progressive Disease (PD)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)Population: Safety population included all participants who received any treatment of moxetumomab pasudotox. The "Overall Number of Participants Analyzed" denotes the number of participants who had achieved a CR.
Time to complete response (CR) was measured from the start of moxetumomab pasudotox treatment to the first documentation of CR and was evaluated only in participants who received any treatment of moxetumomab pasudotox and had achieved a CR. Time to complete response was summarized using Kaplan-Meier estimates (median time, 95% confidence interval \[CI\] for median time).
Outcome measures
| Measure |
20 mcg/kg
n=2 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=1 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=2 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=21 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=2 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Time to Complete Response
|
9.56 months
Interval 4.11 to 15.01
|
3.71 months
Interval 3.71 to 3.71
|
2.53 months
Interval 2.27 to 2.79
|
3.94 months
Interval 2.3 to 6.31
|
—
|
2.53 months
Interval 2.3 to 2.76
|
PRIMARY outcome
Timeframe: From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)Population: Safety population included all participants who received any treatment of moxetumomab pasudotox. The "Overall Number of Participants Analyzed" denotes the number of participants who had achieved an OR (CR or PR).
Time to OR was measured from the start of moxetumomab pasudotox treatment to the first documentation of OR and was evaluated only in participants who received any treatment of moxetumomab pasudotox and had achieved an OR (CR or PR). Objective response (OR) was defined as the participants with confirmed CR or confirmed PR according to Response Evaluation Criteria.
Outcome measures
| Measure |
20 mcg/kg
n=2 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=2 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=3 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=29 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Time to Objective Response
|
8.2 months
Interval 1.38 to 15.01
|
8.18 months
Interval 1.87 to 14.49
|
1.08 months
Interval 0.95 to 2.79
|
1.05 months
Interval 0.92 to 1.58
|
3.02 months
Interval 2.04 to 4.8
|
1.12 months
Interval 0.92 to 2.76
|
PRIMARY outcome
Timeframe: From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)Population: Safety population included all participants who received any treatment of moxetumomab pasudotox. Here, the "Overall Number of Participants Analyzed" denotes the number of participants who had achieved CR and had the first documented non-CR till end of the study.
Duration of CR was measured from the first documentation of CR to the first documented non-CR and was evaluated in participants who had achieved an CR. Duration of CR were summarized using Kaplan-Meier estimates (median time, 95% CI for median time).
Outcome measures
| Measure |
20 mcg/kg
n=1 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=1 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=9 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=1 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Duration of Complete Response
|
25.89 months
Not estimable because insufficient number of participants have events (progressed or relapsed).
|
70.34 months
Not estimable because insufficient number of participants have events (progressed or relapsed).
|
—
|
42.35 months
Interval 17.45 to
Not estimable because insufficient number of participants have events (progressed or relapsed).
|
—
|
NA months
Not estimable because insufficient number of participants have events (progressed or relapsed).
|
PRIMARY outcome
Timeframe: From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)Population: Safety population included all participants who received any treatment of moxetumomab pasudotox. Here, the "Overall Number of Participants Analyzed" denotes the number of participants who had achieved an OR (CR or PR) and had the first documented non-response of SD, PD, or relapse.
Duration of response was measured from the first documentation of objective response (OR) to the first documented non-response of SD, PD, or relapse and was only evaluated in participants who had achieved an OR (CR or PR). Duration of OR was summarized using Kaplan-Meier estimates (median time, 95% CI for median time).
Outcome measures
| Measure |
20 mcg/kg
n=1 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=1 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=6 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=1 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=1 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Duration of Objective Response
|
80.95 months
Not estimable because insufficient number of participants have events (progressed or relapsed).
|
78.29 months
Not estimable because insufficient number of participants have events (progressed or relapsed).
|
—
|
NA months
Interval 52.11 to
Not estimable because insufficient number of participants have events (progressed or relapsed).
|
8.34 months
Not estimable because insufficient number of participants have events (progressed or relapsed).
|
84.44 months
Not estimable because insufficient number of participants have events (progressed or relapsed).
|
PRIMARY outcome
Timeframe: From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)Population: Safety population included all participants who received any treatment of moxetumomab pasudotox.
Time to disease progression/relapse is measured from the start of moxetumomab pasudotox treatment until the first documentation of disease progression or relapse and was summarized using Kaplan-Meier estimates (median time, 95% CI for median time).
Outcome measures
| Measure |
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=3 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=33 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Time to Progression
|
NA months
Not estimable because insufficient number of participants have events (progressed or relapsed).
|
82.07 months
Interval 2.0 to 82.07
|
NA months
Interval 0.92 to
Not estimable because insufficient number of participants have events (progressed or relapsed).
|
NA months
Not estimable because insufficient number of participants have events (progressed or relapsed).
|
11.33 months
Not estimable because insufficient number of participants have events (progressed or relapsed).
|
NA months
Not estimable because insufficient number of participants have events (progressed or relapsed).
|
PRIMARY outcome
Timeframe: From Baseline (predose of Cycle 1 Day 1) through end of study (until CR, PD, initiation of alternative therapy, unacceptable toxicity, development of neutralizing antibodies, or other study discontinuation reasons) (approximately 8 years)Population: Safety population included all participants who received any treatment of moxetumomab pasudotox.
PFS was measured from the start of moxetumomab pasudotox treatment until the first documentation of disease progression/relapse or death, whichever occurred first. PFS was summarized using Kaplan-Meier estimates (median time, 95% CI for median time).
Outcome measures
| Measure |
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=3 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=33 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
NA months
Not estimable because insufficient number of participants have events (progressed or relapsed).
|
82.07 months
Interval 2.0 to 82.07
|
NA months
Interval 0.92 to
Not estimable because insufficient number of participants have events (progressed or relapsed).
|
NA months
Not estimable because insufficient number of participants have events (progressed or relapsed).
|
11.33 months
Not estimable because insufficient number of participants have events (progressed or relapsed).
|
NA months
Not estimable because insufficient number of participants have events (progressed or relapsed).
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1: pre-infusion; at 15 minutes (min) during the infusion; at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 hours (h) post infusionPopulation: The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The "Overall Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.
The Tmax is the time to reach maximum observed plasma concentration of Moxetumomab Pasudotox.
Outcome measures
| Measure |
20 mcg/kg
n=2 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=2 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=11 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=2 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Moxetumomab Pasudotox for Cycle 1 on Day 1
|
0.367 hours
Interval 0.233 to 0.5
|
0.467 hours
Interval 0.417 to 0.517
|
0.267 hours
Interval 0.25 to 0.417
|
0.417 hours
Interval 0.25 to 0.5
|
0.508 hours
Interval 0.383 to 0.633
|
0.467 hours
Interval 0.45 to 0.483
|
PRIMARY outcome
Timeframe: Cycle 1 Day 5: pre infusion; at 15 min during the infusion, at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 h post infusionPopulation: The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The "Overall Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.
The Tmax is the time to reach maximum observed plasma concentration of Moxetumomab Pasudotox.
Outcome measures
| Measure |
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=2 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=12 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Moxetumomab Pasudotox for Cycle 1 on Day 5
|
0.250 hours
Interval 0.25 to 0.533
|
0.517 hours
Interval 0.417 to 0.617
|
0.475 hours
Interval 0.417 to 1.0
|
0.417 hours
Interval 0.283 to 0.517
|
0.500 hours
Interval 0.25 to 0.55
|
0.467 hours
Interval 0.417 to 0.483
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1: pre-infusion; at 15 min during the infusion; at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 h post infusionPopulation: The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The "Overall Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.
The Cmax is the maximum observed plasma concentration of Moxetumomab Pasudotox.
Outcome measures
| Measure |
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=2 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=12 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox for Cycle 1 on Day 1
|
49.4 nanogram per milliliter (ng/mL)
Standard Deviation 46.3
|
443 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
290 nanogram per milliliter (ng/mL)
Standard Deviation 107
|
435 nanogram per milliliter (ng/mL)
Standard Deviation 260
|
77.5 nanogram per milliliter (ng/mL)
Standard Deviation 70.0
|
86.3 nanogram per milliliter (ng/mL)
Standard Deviation 41.9
|
PRIMARY outcome
Timeframe: Cycle 1 Day 5: pre infusion; at 15 min during the infusion, at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 h post infusionPopulation: The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The "Overall Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.
The Cmax is the maximum observed plasma concentration of Moxetumomab Pasudotox.
Outcome measures
| Measure |
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=3 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=12 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) for Moxetumomab Pasudotox for Cycle 1 on Day 5
|
161 ng/mL
Standard Deviation 136
|
420 ng/mL
Standard Deviation 384
|
701 ng/mL
Standard Deviation 328
|
738 ng/mL
Standard Deviation 316
|
103 ng/mL
Standard Deviation 40.5
|
135 ng/mL
Standard Deviation 49.1
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1: pre-infusion; at 15 min during the infusion; at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 h post infusionPopulation: The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The "Overall Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Outcome measures
| Measure |
20 mcg/kg
n=2 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=2 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=11 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=2 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-last]) of Moxetumomab Pasudotox for Cycle 1 on Day 1
|
109 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
897 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
183 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation 146
|
558 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation 590
|
113 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
31.0 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation 20.9
|
PRIMARY outcome
Timeframe: Cycle 1 Day 5: pre infusion; at 15 min during the infusion, at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 h post infusionPopulation: The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The "Overall Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Outcome measures
| Measure |
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=2 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=12 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-last]) of Moxetumomab Pasudotox for Cycle 1 on Day 5
|
93.2 ng*h/mL
Standard Deviation 113
|
1360 ng*h/mL
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
1640 ng*h/mL
Standard Deviation 1270
|
1920 ng*h/mL
Standard Deviation 1290
|
179 ng*h/mL
Standard Deviation 155
|
90.2 ng*h/mL
Standard Deviation 52.3
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1: pre-infusion; at 15 min during the infusion; at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 h post infusionPopulation: The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The "Overall Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.
Systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by area under plasma concentration-time curve from time zero to infinite time (AUC\[0-infinity\]).
Outcome measures
| Measure |
20 mcg/kg
n=1 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=2 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=1 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=8 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=2 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Systemic Clearance (CL) of Moxetumomab Pasudotox for Cycle 1 on Day 1
|
49.1 Milliliter/kilogram/hour (mL/kg/h)
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
43.9 Milliliter/kilogram/hour (mL/kg/h)
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
91.8 Milliliter/kilogram/hour (mL/kg/h)
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
106 Milliliter/kilogram/hour (mL/kg/h)
Standard Deviation 80.2
|
32.6 Milliliter/kilogram/hour (mL/kg/h)
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 5: pre infusion; at 15 min during the infusion, at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 h post infusionPopulation: The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The "Overall Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.
Systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by AUC(0-infinity).
Outcome measures
| Measure |
20 mcg/kg
n=1 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=2 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=10 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=2 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=2 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Systemic Clearance (CL) of Moxetumomab Pasudotox for Cycle 1 on Day 5
|
66.3 mL/kg/h
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
18.7 mL/kg/h
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
45.5 mL/kg/h
Standard Deviation 47.6
|
33.3 mL/kg/h
Standard Deviation 37.5
|
13.3 mL/kg/h
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
68.9 mL/kg/h
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1: pre-infusion; at 15 min during the infusion; at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 h post infusionPopulation: The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The "Overall Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.
The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Outcome measures
| Measure |
20 mcg/kg
n=1 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=2 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=1 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=8 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=2 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Terminal Phase Elimination Half Life (t1/2) of Moxetumomab Pasudotox for Cycle 1 on Day 1
|
3.77 hours
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
1.00 hours
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
0.375 hours
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
0.799 hours
Standard Deviation 0.755
|
0.643 hours
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 5: pre infusion; at 15 min during the infusion, at the end of infusion (approximately 5-7 minutes before the end of infusion); and at 1, 1.5, 2, 4, 8, and 12 h post infusionPopulation: The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The "Overall Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.
The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Outcome measures
| Measure |
20 mcg/kg
n=1 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=2 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=10 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=2 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=2 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Terminal Phase Elimination Half Life (t1/2) of Moxetumomab Pasudotox for Cycle 1 on Day 5
|
0.404 hours
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
1.86 hours
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
1.66 hours
Standard Deviation 0.928
|
2.06 hours
Standard Deviation 0.980
|
2.20 hours
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
0.369 hours
Standard Deviation NA
Standard deviation was reported only when the number of participants analyzed were \>= 3.
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 and Day 5: pre-infusion, at 15 min during the infusion, at the end of infusion, and at 1, 1.5, 2, 4, 8, and 12 h post infusionPopulation: The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The "Overall Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.
The AUC accumulation ratio of moxetumomab pasudotox was calculated as the geometric mean ratio of AUC(0-last) on the last day and the first day of a multiple dose regimen: Day 5/Day 1.
Outcome measures
| Measure |
20 mcg/kg
n=2 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=2 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=11 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=2 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
AUC Accumulation Ratio of Moxetumomab Pasudotox for Cycle 1
|
3.09 ratio
Interval 0.0328 to 6.15
|
1.93 ratio
Interval 1.2 to 2.66
|
12.4 ratio
Interval 1.99 to 25.0
|
3.63 ratio
Interval 1.73 to 21.8
|
2.62 ratio
Interval 1.22 to 4.02
|
3.08 ratio
Interval 2.61 to 3.39
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 and Day 5: pre-infusion, at 15 min during the infusion, at the end of infusion, and at 1, 1.5, 2, 4, 8, and 12 h post infusionPopulation: The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The "Overall Number of Participants Analyzed" denotes the number of participants evaluated for this outcome measure.
The Cmax accumulation ratio of moxetumomab pasudotox was calculated as the geometric mean ratio of Cmax on the last day and the first day of a multiple dose regimen: Day 5/Day 1.
Outcome measures
| Measure |
20 mcg/kg
n=2 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=2 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=11 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=2 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Cmax Accumulation Ratio of Moxetumomab Pasudotox for Cycle 1
|
2.12 ratio
Interval 0.839 to 3.4
|
1.48 ratio
Interval 1.3 to 1.66
|
2.51 ratio
Interval 1.47 to 3.26
|
1.58 ratio
Interval 1.09 to 3.94
|
1.11 ratio
Interval 0.934 to 1.29
|
1.73 ratio
Interval 1.39 to 1.73
|
SECONDARY outcome
Timeframe: Up to end of treatment (approximately 8 years)Population: Safety population included all participants who received any treatment of moxetumomab pasudotox.
Participants tested for immunogenicity to moxetumomab pasudotox prior to enrollment, before each cycle and at end of study. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of moxetumomab pasudotox to its target, cluster of differentiation 22 (CD22), coated onto enzyme linked immunosorbent assay (ELISA) plates. Significant level of neutralizing antibody activity defined as the capacity of test plasma to inhibit \>50% of the binding of CAT-8015 to CD22 using an ELISA-based method.
Outcome measures
| Measure |
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=3 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=33 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Positive Neutralizing Antibodies and Correlation to Antitumor Activity
|
2 Participants
|
1 Participants
|
0 Participants
|
7 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Prior to enrollment during screening, and for participants still having malignant cells, the test was to be repeated prior to each cycle of therapy, at the end of treatment, and end of the study (approximately 8 years)Population: Safety population included all participants who received any treatment of moxetumomab pasudotox.
Participants malignant cells (peripheral blood) were tested for cluster of differentiation 22 (CD22) expression by fluorescence-activated cell sorter (FACS) analysis.
Outcome measures
| Measure |
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=3 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=33 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
CD22 Expression Levels From Peripheral Blood by Best Response
Peripheral Blood: Complete Response
|
72632.0 sites per cell
Standard Deviation 12010.9
|
43803.0 sites per cell
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
61773.0 sites per cell
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
68141.3 sites per cell
Standard Deviation 13614.0
|
—
|
65434.0 sites per cell
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
|
CD22 Expression Levels From Peripheral Blood by Best Response
Peripheral Blood: Partial Response
|
—
|
76264.0 sites per cell
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
52495.0 sites per cell
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
33259.9 sites per cell
Standard Deviation 25479.5
|
38402.7 sites per cell
Standard Deviation 14131.9
|
78356.0 sites per cell
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
|
CD22 Expression Levels From Peripheral Blood by Best Response
Peripheral Blood: Stable Disease
|
38939.0 sites per cell
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
84157.0 sites per cell
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
—
|
46089.3 sites per cell
Standard Deviation 9644.6
|
—
|
—
|
|
CD22 Expression Levels From Peripheral Blood by Best Response
Peripheral Blood: ProgressiveDisease
|
—
|
—
|
24645.0 sites per cell
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to enrollment during screening, and for participants still having malignant cells, the test was to be repeated prior to each cycle of therapy, at the end of treatment, and end of the study (approximately 8 years)Population: Safety population included all participants who received any treatment of moxetumomab pasudotox.
Participants malignant cells (paraffin block biopsy specimen) were tested for CD22 expression by FACS analysis.
Outcome measures
| Measure |
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=3 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=33 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
CD22 Expression Levels From Bone Marrow by Best Response
Bone Marrow: Partial Response
|
—
|
—
|
—
|
37732.5 sites per cell
Standard Deviation 9918.6
|
36286.0 sites per cell
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
—
|
|
CD22 Expression Levels From Bone Marrow by Best Response
Bone Marrow: Complete Response
|
—
|
50190.0 sites per cell
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
—
|
55850.5 sites per cell
Standard Deviation 18482.2
|
—
|
75157.0 sites per cell
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
|
CD22 Expression Levels From Bone Marrow by Best Response
Bone Marrow: Stable Disease
|
—
|
80400.0 sites per cell
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
—
|
36767.5 sites per cell
Standard Deviation 720.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to enrollment during screening, and for participants still having malignant cells, the test was to be repeated prior to each cycle of therapy, at the end of treatment, and end of the study (approximately 8 years)Population: Safety population included all participants who received any treatment of moxetumomab pasudotox.
Soluble CD22 was collected from the participant's plasma and was performed at the NCI using an ELISA method.
Outcome measures
| Measure |
20 mcg/kg
n=3 Participants
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=3 Participants
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 Participants
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=33 Participants
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
5 mcg/kg
n=3 Participants
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 Participants
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Soluble CD22 Levels by Best Response
Complete Response
|
60021.0 picogram/mL
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
5109.0 picogram/mL
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
10232.0 picogram/mL
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
22202.9 picogram/mL
Standard Deviation 27809.4
|
—
|
2583.0 picogram/mL
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
|
Soluble CD22 Levels by Best Response
Partial Response
|
—
|
5122.0 picogram/mL
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
18238.5 picogram/mL
Standard Deviation 45.5
|
39493.5 picogram/mL
Standard Deviation 31216.9
|
3016.3 picogram/mL
Standard Deviation 1821.3
|
16675.0 picogram/mL
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
|
Soluble CD22 Levels by Best Response
Stable Disease
|
184750.0 picogram/mL
Standard Deviation 21566.8
|
528000.0 picogram/mL
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
—
|
134129.5 picogram/mL
Standard Deviation 150498.4
|
—
|
—
|
|
Soluble CD22 Levels by Best Response
Progressive Disease
|
—
|
—
|
7484.0 picogram/mL
Standard Deviation NA
Standard deviation was not evaluable since only 1 participant was evaluated.
|
—
|
—
|
—
|
Adverse Events
5 mcg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
10 mcg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
20 mcg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
30 mcg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
40 mcg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
50 mcg/kg
Serious events: 4 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5 mcg/kg
n=3 participants at risk
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 participants at risk
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
20 mcg/kg
n=3 participants at risk
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=3 participants at risk
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 participants at risk
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=33 participants at risk
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
6.1%
2/33 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
3.0%
1/33 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
3.0%
1/33 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
3.0%
1/33 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
3.0%
1/33 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/33 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
3.0%
1/33 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/33 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
3.0%
1/33 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
Other adverse events
| Measure |
5 mcg/kg
n=3 participants at risk
Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
10 mcg/kg
n=3 participants at risk
Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
20 mcg/kg
n=3 participants at risk
Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
30 mcg/kg
n=3 participants at risk
Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
40 mcg/kg
n=4 participants at risk
Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
50 mcg/kg
n=33 participants at risk
Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
6.1%
2/33 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
66.7%
2/3 • Number of events 4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
66.7%
2/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
75.8%
25/33 • Number of events 62 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
6.1%
2/33 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
9.1%
3/33 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
12.1%
4/33 • Number of events 7 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
66.7%
2/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
15.2%
5/33 • Number of events 6 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 6 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
15.2%
5/33 • Number of events 5 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
9.1%
3/33 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
50.0%
2/4 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
39.4%
13/33 • Number of events 21 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
9.1%
3/33 • Number of events 5 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
30.3%
10/33 • Number of events 17 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
100.0%
3/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
24.2%
8/33 • Number of events 10 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
General disorders
Oedema
|
33.3%
1/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
50.0%
2/4 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
24.2%
8/33 • Number of events 10 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Number of events 5 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
100.0%
3/3 • Number of events 8 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
75.0%
3/4 • Number of events 7 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
39.4%
13/33 • Number of events 22 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
66.7%
2/3 • Number of events 4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
100.0%
3/3 • Number of events 5 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
45.5%
15/33 • Number of events 25 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
General disorders
Thrombosis in device
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
12.1%
4/33 • Number of events 4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
21.2%
7/33 • Number of events 8 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
6.1%
2/33 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
6.1%
2/33 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
100.0%
3/3 • Number of events 5 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
50.0%
2/4 • Number of events 5 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
75.8%
25/33 • Number of events 72 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • Number of events 7 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
66.7%
2/3 • Number of events 4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
25.0%
1/4 • Number of events 4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
72.7%
24/33 • Number of events 63 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
15.2%
5/33 • Number of events 10 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
15.2%
5/33 • Number of events 5 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Investigations
Blood bilirubin increased
|
66.7%
2/3 • Number of events 4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
6.1%
2/33 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
12.1%
4/33 • Number of events 5 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
30.3%
10/33 • Number of events 19 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
25.0%
1/4 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
6.1%
2/33 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Investigations
Blood uric acid increased
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
3.0%
1/33 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Investigations
Electrocardiogram qt prolonged
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
66.7%
2/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
6.1%
2/33 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
21.2%
7/33 • Number of events 11 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Investigations
Haemoglobin decreased
|
66.7%
2/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
66.7%
2/3 • Number of events 4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
27.3%
9/33 • Number of events 15 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Investigations
Haptoglobin decreased
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
21.2%
7/33 • Number of events 8 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
66.7%
2/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
50.0%
2/4 • Number of events 7 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
15.2%
5/33 • Number of events 9 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
30.3%
10/33 • Number of events 14 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
50.0%
2/4 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
18.2%
6/33 • Number of events 9 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Investigations
Weight increased
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
18.2%
6/33 • Number of events 7 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Investigations
White blood cell count decreased
|
66.7%
2/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
66.7%
2/3 • Number of events 4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
50.0%
2/4 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
51.5%
17/33 • Number of events 23 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
6.1%
2/33 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
27.3%
9/33 • Number of events 10 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
66.7%
2/3 • Number of events 5 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
66.7%
2/3 • Number of events 4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
50.0%
2/4 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
39.4%
13/33 • Number of events 22 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
15.2%
5/33 • Number of events 6 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
36.4%
12/33 • Number of events 20 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
18.2%
6/33 • Number of events 7 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
57.6%
19/33 • Number of events 31 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
12.1%
4/33 • Number of events 7 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
66.7%
2/3 • Number of events 7 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
100.0%
3/3 • Number of events 9 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
75.0%
3/4 • Number of events 9 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
75.8%
25/33 • Number of events 72 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
11/33 • Number of events 18 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
33.3%
1/3 • Number of events 4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
3.0%
1/33 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
66.7%
2/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
6.1%
2/33 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
21.2%
7/33 • Number of events 15 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
66.7%
2/3 • Number of events 5 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
75.0%
3/4 • Number of events 4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
21.2%
7/33 • Number of events 10 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
30.3%
10/33 • Number of events 16 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
18.2%
6/33 • Number of events 8 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
12.1%
4/33 • Number of events 4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
25.0%
1/4 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
3.0%
1/33 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
9.1%
3/33 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
66.7%
2/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
100.0%
3/3 • Number of events 7 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
50.0%
2/4 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
60.6%
20/33 • Number of events 36 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
9.1%
3/33 • Number of events 5 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
15.2%
5/33 • Number of events 5 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
24.2%
8/33 • Number of events 10 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
66.7%
2/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
25.0%
1/4 • Number of events 7 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
39.4%
13/33 • Number of events 21 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/33 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
12.1%
4/33 • Number of events 5 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
9.1%
3/33 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
24.2%
8/33 • Number of events 9 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
27.3%
9/33 • Number of events 13 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
18.2%
6/33 • Number of events 6 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
15.2%
5/33 • Number of events 5 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
9.1%
3/33 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
12.1%
4/33 • Number of events 5 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
3.0%
1/33 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
9.1%
3/33 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
9.1%
3/33 • Number of events 4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
24.2%
8/33 • Number of events 10 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Vascular disorders
Capillary leak syndrome
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
21.2%
7/33 • Number of events 8 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
66.7%
2/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
30.3%
10/33 • Number of events 16 • From start of study drug administration until 30 days after the last dose of study drug (approximately 8 years)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER