TriangleNCT02669017 · OUTCOME
Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- day*ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
What was measured
AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199). Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
Analysis population: Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
Groups in this outcome
Part 1: 15 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Part 1: 30 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Part 1: 60 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Part 1: 90 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
Parts 1 and 2: 120 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Parts 1 and 2: 150 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
Part 1: 200 μg/kg Q3W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
Part 1: 200 μg/kg Q6W
Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
| Group | Source count |
|---|---|
| Part 1: 15 μg/kg Q3W | 4 |
| Part 1: 30 μg/kg Q3W | 4 |
| Part 1: 60 μg/kg Q3W | 4 |
| Part 1: 90 μg/kg Q3W | 5 |
| Parts 1 and 2: 120 μg/kg Q3W | 42 |
| Parts 1 and 2: 150 μg/kg Q3W | 88 |
| Part 1: 200 μg/kg Q3W | 14 |
| Part 1: 200 μg/kg Q6W | 22 |
Reported measurements
PBD conjugated Ab: Cycle 1
| Group | Source count |
|---|---|
| Part 1: 15 μg/kg Q3W | 4 |
| Part 1: 30 μg/kg Q3W | 4 |
| Part 1: 60 μg/kg Q3W | 4 |
| Part 1: 90 μg/kg Q3W | 5 |
| Parts 1 and 2: 120 μg/kg Q3W | 42 |
| Parts 1 and 2: 150 μg/kg Q3W | 88 |
| Part 1: 200 μg/kg Q3W | 14 |
| Part 1: 200 μg/kg Q6W | 22 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: 15 μg/kg Q3W | 1063 | 1340 | Not reported | Not reported | Not reported |
| Part 1: 30 μg/kg Q3W | 2390 | 826 | Not reported | Not reported | Not reported |
| Part 1: 60 μg/kg Q3W | 3875 | 3228 | Not reported | Not reported | Not reported |
| Part 1: 90 μg/kg Q3W | 6587 | 6842 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 120 μg/kg Q3W | 13544 | 7503 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 150 μg/kg Q3W | 14258 | 8248 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q3W | 30571 | 12425 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q6W | 30386 | 16960 | Not reported | Not reported | Not reported |
PBD conjugated Ab: Cycle 2
| Group | Source count |
|---|---|
| Part 1: 15 μg/kg Q3W | 4 |
| Part 1: 30 μg/kg Q3W | 4 |
| Part 1: 60 μg/kg Q3W | 3 |
| Part 1: 90 μg/kg Q3W | 5 |
| Parts 1 and 2: 120 μg/kg Q3W | 40 |
| Parts 1 and 2: 150 μg/kg Q3W | 72 |
| Part 1: 200 μg/kg Q3W | 11 |
| Part 1: 200 μg/kg Q6W | 12 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: 15 μg/kg Q3W | 1933 | 2289 | Not reported | Not reported | Not reported |
| Part 1: 30 μg/kg Q3W | 2955 | 1132 | Not reported | Not reported | Not reported |
| Part 1: 60 μg/kg Q3W | 5573 | 4827 | Not reported | Not reported | Not reported |
| Part 1: 90 μg/kg Q3W | 10369 | 11656 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 120 μg/kg Q3W | 18707 | 10505 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 150 μg/kg Q3W | 23109 | 15370 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q3W | 48183 | 20288 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q6W | 39609 | 24852 | Not reported | Not reported | Not reported |
total Ab: Cycle 1
| Group | Source count |
|---|---|
| Part 1: 15 μg/kg Q3W | 4 |
| Part 1: 30 μg/kg Q3W | 4 |
| Part 1: 60 μg/kg Q3W | 4 |
| Part 1: 90 μg/kg Q3W | 5 |
| Parts 1 and 2: 120 μg/kg Q3W | 41 |
| Parts 1 and 2: 150 μg/kg Q3W | 88 |
| Part 1: 200 μg/kg Q3W | 14 |
| Part 1: 200 μg/kg Q6W | 22 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: 15 μg/kg Q3W | 1185 | 1540 | Not reported | Not reported | Not reported |
| Part 1: 30 μg/kg Q3W | 3194 | 1136 | Not reported | Not reported | Not reported |
| Part 1: 60 μg/kg Q3W | 5032 | 4334 | Not reported | Not reported | Not reported |
| Part 1: 90 μg/kg Q3W | 8869 | 9108 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 120 μg/kg Q3W | 15980 | 7649 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 150 μg/kg Q3W | 16973 | 9745 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q3W | 33834 | 14888 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q6W | 36099 | 20829 | Not reported | Not reported | Not reported |
total Ab: Cycle 2
| Group | Source count |
|---|---|
| Part 1: 15 μg/kg Q3W | 4 |
| Part 1: 30 μg/kg Q3W | 4 |
| Part 1: 60 μg/kg Q3W | 3 |
| Part 1: 90 μg/kg Q3W | 5 |
| Parts 1 and 2: 120 μg/kg Q3W | 39 |
| Parts 1 and 2: 150 μg/kg Q3W | 72 |
| Part 1: 200 μg/kg Q3W | 11 |
| Part 1: 200 μg/kg Q6W | 12 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: 15 μg/kg Q3W | 1924 | 2576 | Not reported | Not reported | Not reported |
| Part 1: 30 μg/kg Q3W | 3986 | 1725 | Not reported | Not reported | Not reported |
| Part 1: 60 μg/kg Q3W | 7958 | 6882 | Not reported | Not reported | Not reported |
| Part 1: 90 μg/kg Q3W | 14025 | 15704 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 120 μg/kg Q3W | 23428 | 13513 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 150 μg/kg Q3W | 28657 | 19457 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q3W | 57450 | 26899 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q6W | 49892 | 31012 | Not reported | Not reported | Not reported |
SG3199: Cycle 1
| Group | Source count |
|---|---|
| Part 1: 15 μg/kg Q3W | 0 |
| Part 1: 30 μg/kg Q3W | 0 |
| Part 1: 60 μg/kg Q3W | 0 |
| Part 1: 90 μg/kg Q3W | 1 |
| Parts 1 and 2: 120 μg/kg Q3W | 4 |
| Parts 1 and 2: 150 μg/kg Q3W | 28 |
| Part 1: 200 μg/kg Q3W | 4 |
| Part 1: 200 μg/kg Q6W | 16 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: 90 μg/kg Q3W | 0.00213 | NA | Not reported | Not reported | Standard deviation could not be determined as only one participant had evaluable data. |
| Parts 1 and 2: 120 μg/kg Q3W | 0.00462 | 0.00671 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 150 μg/kg Q3W | 0.0222 | 0.0423 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q3W | 0.0174 | 0.0303 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q6W | 0.0436 | 0.0959 | Not reported | Not reported | Not reported |
SG3199: Cycle 2
| Group | Source count |
|---|---|
| Part 1: 15 μg/kg Q3W | 0 |
| Part 1: 30 μg/kg Q3W | 0 |
| Part 1: 60 μg/kg Q3W | 0 |
| Part 1: 90 μg/kg Q3W | 2 |
| Parts 1 and 2: 120 μg/kg Q3W | 4 |
| Parts 1 and 2: 150 μg/kg Q3W | 15 |
| Part 1: 200 μg/kg Q3W | 3 |
| Part 1: 200 μg/kg Q6W | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: 90 μg/kg Q3W | 0.0242 | 0.0234 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 120 μg/kg Q3W | 0.154 | 0.286 | Not reported | Not reported | Not reported |
| Parts 1 and 2: 150 μg/kg Q3W | 0.0108 | 0.0248 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q3W | 0.00425 | 0.00461 | Not reported | Not reported | Not reported |
| Part 1: 200 μg/kg Q6W | 0.00332 | 0.00215 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1340
- value
- 1063
- group Id
- OG001
- spread
- 826
- value
- 2390
- group Id
- OG002
- spread
- 3228
- value
- 3875
- group Id
- OG003
- spread
- 6842
- value
- 6587
- group Id
- OG004
- spread
- 7503
- value
- 13544
- group Id
- OG005
- spread
- 8248
- value
- 14258
- group Id
- OG006
- spread
- 12425
- value
- 30571
- group Id
- OG007
- spread
- 16960
- value
- 30386
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 42
- group Id
- OG005
- value
- 88
- group Id
- OG006
- value
- 14
- group Id
- OG007
- value
- 22
- units
- Participants
- title
- PBD conjugated Ab: Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 2289
- value
- 1933
- group Id
- OG001
- spread
- 1132
- value
- 2955
- group Id
- OG002
- spread
- 4827
- value
- 5573
- group Id
- OG003
- spread
- 11656
- value
- 10369
- group Id
- OG004
- spread
- 10505
- value
- 18707
- group Id
- OG005
- spread
- 15370
- value
- 23109
- group Id
- OG006
- spread
- 20288
- value
- 48183
- group Id
- OG007
- spread
- 24852
- value
- 39609
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 40
- group Id
- OG005
- value
- 72
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 12
- units
- Participants
- title
- PBD conjugated Ab: Cycle 2
- categories
- measurements
- group Id
- OG000
- spread
- 1540
- value
- 1185
- group Id
- OG001
- spread
- 1136
- value
- 3194
- group Id
- OG002
- spread
- 4334
- value
- 5032
- group Id
- OG003
- spread
- 9108
- value
- 8869
- group Id
- OG004
- spread
- 7649
- value
- 15980
- group Id
- OG005
- spread
- 9745
- value
- 16973
- group Id
- OG006
- spread
- 14888
- value
- 33834
- group Id
- OG007
- spread
- 20829
- value
- 36099
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 41
- group Id
- OG005
- value
- 88
- group Id
- OG006
- value
- 14
- group Id
- OG007
- value
- 22
- units
- Participants
- title
- total Ab: Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 2576
- value
- 1924
- group Id
- OG001
- spread
- 1725
- value
- 3986
- group Id
- OG002
- spread
- 6882
- value
- 7958
- group Id
- OG003
- spread
- 15704
- value
- 14025
- group Id
- OG004
- spread
- 13513
- value
- 23428
- group Id
- OG005
- spread
- 19457
- value
- 28657
- group Id
- OG006
- spread
- 26899
- value
- 57450
- group Id
- OG007
- spread
- 31012
- value
- 49892
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 39
- group Id
- OG005
- value
- 72
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 12
- units
- Participants
- title
- total Ab: Cycle 2
- categories
- measurements
- comment
- Standard deviation could not be determined as only one participant had evaluable data.
- group Id
- OG003
- spread
- NA
- value
- 0.00213
- group Id
- OG004
- spread
- 0.00671
- value
- 0.00462
- group Id
- OG005
- spread
- 0.0423
- value
- 0.0222
- group Id
- OG006
- spread
- 0.0303
- value
- 0.0174
- group Id
- OG007
- spread
- 0.0959
- value
- 0.0436
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 28
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 16
- units
- Participants
- title
- SG3199: Cycle 1
- categories
- measurements
- group Id
- OG003
- spread
- 0.0234
- value
- 0.0242
- group Id
- OG004
- spread
- 0.286
- value
- 0.154
- group Id
- OG005
- spread
- 0.0248
- value
- 0.0108
- group Id
- OG006
- spread
- 0.00461
- value
- 0.00425
- group Id
- OG007
- spread
- 0.00215
- value
- 0.00332
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 15
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 4
- units
- Participants
- title
- SG3199: Cycle 2
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 42
- group Id
- OG005
- value
- 88
- group Id
- OG006
- value
- 14
- group Id
- OG007
- value
- 22
- units
- Participants
- description
- AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199). Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG000
- title
- Part 1: 15 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG001
- title
- Part 1: 30 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG002
- title
- Part 1: 60 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
- id
- OG003
- title
- Part 1: 90 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
- id
- OG004
- title
- Parts 1 and 2: 120 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W). Parts 1 and 2 are pooled for PK analysis as specified in the protocol.
- id
- OG005
- title
- Parts 1 and 2: 150 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
- id
- OG006
- title
- Part 1: 200 μg/kg Q3W
- description
- Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 6 week cycle (Q6W). Analysis was performed separately for Q3W and Q6W treatment cycles as specified in the protocol.
- id
- OG007
- title
- Part 1: 200 μg/kg Q6W
- param Type
- MEAN
- population Description
- Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.
- reporting Status
- POSTED
- time Frame
- Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)
- title
- Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402
- type
- SECONDARY
- unit Of Measure
- day*ng/mL
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Preserved source evidence · Not medical advice