TriangleNCT03386513 · OUTCOME
Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of IMGN632 (ADC) and Total Antibody
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- hours*µg/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1 and Cycle 3 (each cycle length = 21 days)
Analysis population: The PK analysis set included all participants who received at least 1 dose of study drug and from whom results of concentration had been obtained at least 1 sampling point. PK data were collected and analyses were conducted in participants per treatment schedule and dose in both phases (dose escalation and expansion) combined. Here, 'number analyzed' = participants evaluable for specified categories.
Groups in this outcome
Schedule A: IMGN632 0.015 mg/kg
Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Schedule A: IMGN632 0.045 mg/kg
Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Schedule A: IMGN632 0.09 mg/kg
Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Schedule A: IMGN632 0.18 mg/kg
Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Schedule A: IMGN632 0.3 mg/kg
Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Schedule A: IMGN632 0.45 mg/kg
Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Schedule B: IMGN632 0.015 mg/kg
Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
Schedule B: IMGN632 0.03 mg/kg
Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
Schedule B: IMGN632 0.06 mg/kg
Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
| Group | Source count |
|---|---|
| Schedule A: IMGN632 0.015 mg/kg | 2 |
| Schedule A: IMGN632 0.045 mg/kg | 107 |
| Schedule A: IMGN632 0.09 mg/kg | 23 |
| Schedule A: IMGN632 0.18 mg/kg | 7 |
| Schedule A: IMGN632 0.3 mg/kg | 5 |
| Schedule A: IMGN632 0.45 mg/kg | 2 |
| Schedule B: IMGN632 0.015 mg/kg | 2 |
| Schedule B: IMGN632 0.03 mg/kg | 6 |
| Schedule B: IMGN632 0.06 mg/kg | 13 |
Reported measurements
IMGN632 ADC: Cycle 1
| Group | Source count |
|---|---|
| Schedule A: IMGN632 0.015 mg/kg | 2 |
| Schedule A: IMGN632 0.045 mg/kg | 107 |
| Schedule A: IMGN632 0.09 mg/kg | 23 |
| Schedule A: IMGN632 0.18 mg/kg | 7 |
| Schedule A: IMGN632 0.3 mg/kg | 5 |
| Schedule A: IMGN632 0.45 mg/kg | 2 |
| Schedule B: IMGN632 0.015 mg/kg | 2 |
| Schedule B: IMGN632 0.03 mg/kg | 6 |
| Schedule B: IMGN632 0.06 mg/kg | 13 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Schedule A: IMGN632 0.015 mg/kg | 0.0471 | 825 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.045 mg/kg | 0.892 | 223 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.09 mg/kg | 4.12 | 140 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.18 mg/kg | 24.7 | 44 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.3 mg/kg | 46.7 | 66 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.45 mg/kg | 113 | 42 | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.015 mg/kg | 0.0227 | 31 | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.03 mg/kg | 0.792 | 248 | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.06 mg/kg | 1.11 | 269 | Not reported | Not reported | Not reported |
Total Antibody: Cycle 1
| Group | Source count |
|---|---|
| Schedule A: IMGN632 0.015 mg/kg | 1 |
| Schedule A: IMGN632 0.045 mg/kg | 94 |
| Schedule A: IMGN632 0.09 mg/kg | 23 |
| Schedule A: IMGN632 0.18 mg/kg | 7 |
| Schedule A: IMGN632 0.3 mg/kg | 5 |
| Schedule A: IMGN632 0.45 mg/kg | 2 |
| Schedule B: IMGN632 0.015 mg/kg | 0 |
| Schedule B: IMGN632 0.03 mg/kg | 6 |
| Schedule B: IMGN632 0.06 mg/kg | 12 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Schedule A: IMGN632 0.015 mg/kg | 0.152 | NA | Not reported | Not reported | Geometric Coefficient of Variation not calculable with n=1 |
| Schedule A: IMGN632 0.045 mg/kg | 0.939 | 241 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.09 mg/kg | 3.50 | 254 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.18 mg/kg | 31.0 | 66 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.3 mg/kg | 51.8 | 68 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.45 mg/kg | 123 | 50 | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.03 mg/kg | 0.708 | 355 | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.06 mg/kg | 1.02 | 371 | Not reported | Not reported | Not reported |
IMGN632 ADC: Cycle 3
| Group | Source count |
|---|---|
| Schedule A: IMGN632 0.015 mg/kg | 1 |
| Schedule A: IMGN632 0.045 mg/kg | 72 |
| Schedule A: IMGN632 0.09 mg/kg | 3 |
| Schedule A: IMGN632 0.18 mg/kg | 0 |
| Schedule A: IMGN632 0.3 mg/kg | 0 |
| Schedule A: IMGN632 0.45 mg/kg | 0 |
| Schedule B: IMGN632 0.015 mg/kg | 2 |
| Schedule B: IMGN632 0.03 mg/kg | 3 |
| Schedule B: IMGN632 0.06 mg/kg | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Schedule A: IMGN632 0.015 mg/kg | 0.202 | NA | Not reported | Not reported | Geometric Coefficient of Variation not calculable with n=1 |
| Schedule A: IMGN632 0.045 mg/kg | 1.61 | 191 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.09 mg/kg | 12.1 | 56 | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.015 mg/kg | 0.0145 | 1831 | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.03 mg/kg | 1.25 | 185 | Not reported | Not reported | Not reported |
Total Antibody: Cycle 3
| Group | Source count |
|---|---|
| Schedule A: IMGN632 0.015 mg/kg | 0 |
| Schedule A: IMGN632 0.045 mg/kg | 66 |
| Schedule A: IMGN632 0.09 mg/kg | 3 |
| Schedule A: IMGN632 0.18 mg/kg | 0 |
| Schedule A: IMGN632 0.3 mg/kg | 0 |
| Schedule A: IMGN632 0.45 mg/kg | 0 |
| Schedule B: IMGN632 0.015 mg/kg | 1 |
| Schedule B: IMGN632 0.03 mg/kg | 3 |
| Schedule B: IMGN632 0.06 mg/kg | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Schedule A: IMGN632 0.045 mg/kg | 1.41 | 124 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.09 mg/kg | 15.4 | 111 | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.015 mg/kg | 0.0835 | NA | Not reported | Not reported | Geometric Coefficient of Variation not calculable with n=1 |
| Schedule B: IMGN632 0.03 mg/kg | 1.05 | 121 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 825
- value
- 0.0471
- group Id
- OG001
- spread
- 223
- value
- 0.892
- group Id
- OG002
- spread
- 140
- value
- 4.12
- group Id
- OG003
- spread
- 44
- value
- 24.7
- group Id
- OG004
- spread
- 66
- value
- 46.7
- group Id
- OG005
- spread
- 42
- value
- 113
- group Id
- OG006
- spread
- 31
- value
- 0.0227
- group Id
- OG007
- spread
- 248
- value
- 0.792
- group Id
- OG008
- spread
- 269
- value
- 1.11
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 107
- group Id
- OG002
- value
- 23
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 13
- units
- Participants
- title
- IMGN632 ADC: Cycle 1
- categories
- measurements
- comment
- Geometric Coefficient of Variation not calculable with n=1
- group Id
- OG000
- spread
- NA
- value
- 0.152
- group Id
- OG001
- spread
- 241
- value
- 0.939
- group Id
- OG002
- spread
- 254
- value
- 3.50
- group Id
- OG003
- spread
- 66
- value
- 31.0
- group Id
- OG004
- spread
- 68
- value
- 51.8
- group Id
- OG005
- spread
- 50
- value
- 123
- group Id
- OG007
- spread
- 355
- value
- 0.708
- group Id
- OG008
- spread
- 371
- value
- 1.02
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 94
- group Id
- OG002
- value
- 23
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 12
- units
- Participants
- title
- Total Antibody: Cycle 1
- categories
- measurements
- comment
- Geometric Coefficient of Variation not calculable with n=1
- group Id
- OG000
- spread
- NA
- value
- 0.202
- group Id
- OG001
- spread
- 191
- value
- 1.61
- group Id
- OG002
- spread
- 56
- value
- 12.1
- group Id
- OG006
- spread
- 1831
- value
- 0.0145
- group Id
- OG007
- spread
- 185
- value
- 1.25
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 72
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 0
- units
- Participants
- title
- IMGN632 ADC: Cycle 3
- categories
- measurements
- group Id
- OG001
- spread
- 124
- value
- 1.41
- group Id
- OG002
- spread
- 111
- value
- 15.4
- comment
- Geometric Coefficient of Variation not calculable with n=1
- group Id
- OG006
- spread
- NA
- value
- 0.0835
- group Id
- OG007
- spread
- 121
- value
- 1.05
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 66
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 0
- units
- Participants
- title
- Total Antibody: Cycle 3
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 107
- group Id
- OG002
- value
- 23
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 13
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG000
- title
- Schedule A: IMGN632 0.015 mg/kg
- description
- Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG001
- title
- Schedule A: IMGN632 0.045 mg/kg
- description
- Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG002
- title
- Schedule A: IMGN632 0.09 mg/kg
- description
- Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG003
- title
- Schedule A: IMGN632 0.18 mg/kg
- description
- Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG004
- title
- Schedule A: IMGN632 0.3 mg/kg
- description
- Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- OG005
- title
- Schedule A: IMGN632 0.45 mg/kg
- description
- Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- OG006
- title
- Schedule B: IMGN632 0.015 mg/kg
- description
- Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- OG007
- title
- Schedule B: IMGN632 0.03 mg/kg
- description
- Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- OG008
- title
- Schedule B: IMGN632 0.06 mg/kg
- param Type
- GEOMETRIC_MEAN
- population Description
- The PK analysis set included all participants who received at least 1 dose of study drug and from whom results of concentration had been obtained at least 1 sampling point. PK data were collected and analyses were conducted in participants per treatment schedule and dose in both phases (dose escalation and expansion) combined. Here, 'number analyzed' = participants evaluable for specified categories.
- reporting Status
- POSTED
- time Frame
- Cycle 1 and Cycle 3 (each cycle length = 21 days)
- title
- Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of IMGN632 (ADC) and Total Antibody
- type
- SECONDARY
- unit Of Measure
- hours*µg/mL
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Preserved source evidence · Independent clinical review pending · Not medical advice