TriangleNCT03386513 · OUTCOME
AUC0-last of FGN849
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- hours*pg/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1 and Cycle 3 (each cycle length = 21 days)
Analysis population: 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, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
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 | 0 |
| Schedule A: IMGN632 0.045 mg/kg | 87 |
| Schedule A: IMGN632 0.09 mg/kg | 22 |
| 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 | 3 |
| Schedule B: IMGN632 0.06 mg/kg | 12 |
Reported measurements
Cycle 1
| Group | Source count |
|---|---|
| Schedule A: IMGN632 0.015 mg/kg | 0 |
| Schedule A: IMGN632 0.045 mg/kg | 87 |
| Schedule A: IMGN632 0.09 mg/kg | 22 |
| 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 | 3 |
| Schedule B: IMGN632 0.06 mg/kg | 12 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Schedule A: IMGN632 0.045 mg/kg | 171 | 116 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.09 mg/kg | 354 | 99 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.18 mg/kg | 248 | 41 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.3 mg/kg | 1260 | 73 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.45 mg/kg | 1139 | 29 | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.03 mg/kg | 63.5 | 158 | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.06 mg/kg | 177 | 169 | Not reported | Not reported | Not reported |
Cycle 3
| Group | Source count |
|---|---|
| Schedule A: IMGN632 0.015 mg/kg | 0 |
| Schedule A: IMGN632 0.045 mg/kg | 48 |
| 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 | 0 |
| 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 | 125 | 105 | Not reported | Not reported | Not reported |
| Schedule A: IMGN632 0.09 mg/kg | 59.6 | 1541 | Not reported | Not reported | Not reported |
| Schedule B: IMGN632 0.03 mg/kg | 66.1 | 144 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- spread
- 116
- value
- 171
- group Id
- OG002
- spread
- 99
- value
- 354
- group Id
- OG003
- spread
- 41
- value
- 248
- group Id
- OG004
- spread
- 73
- value
- 1260
- group Id
- OG005
- spread
- 29
- value
- 1139
- group Id
- OG007
- spread
- 158
- value
- 63.5
- group Id
- OG008
- spread
- 169
- value
- 177
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 87
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 12
- units
- Participants
- title
- Cycle 1
- categories
- measurements
- group Id
- OG001
- spread
- 105
- value
- 125
- group Id
- OG002
- spread
- 1541
- value
- 59.6
- group Id
- OG007
- spread
- 144
- value
- 66.1
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 48
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 0
- units
- Participants
- title
- Cycle 3
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 87
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 12
- 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
- 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, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
- reporting Status
- POSTED
- time Frame
- Cycle 1 and Cycle 3 (each cycle length = 21 days)
- title
- AUC0-last of FGN849
- type
- SECONDARY
- unit Of Measure
- hours*pg/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice