TriangleNCT01001442 · OUTCOME
Multi-dose Pharmacokinetics Properties of BT062 - Cmax
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- ng/ml
- Interval / dispersion
- Full Range
- Time frame
- Starting with first study drug administration until 30-day follow-up visit (average 4.99 months).
What was measured
Multi-dose Pharmacokinetics properties of BT062 after intravenous (IV) Administration of escalating doses of BT062 as assessed by measuring intact BT062 conjugate. Please note that not all subjects reached Cycle 4 due to early termination . A lower number of samples could be analyzed for Cycle 4.
Analysis population: Safety Population: The Safety population included all subjects who were enrolled and received at least 1 dose of BT062 (n = 35).
Groups in this outcome
BT062 40 mg/m²
40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 50 mg/m²
50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 65 mg/m²
65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 80 mg/m²
80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 100 mg/m²
100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 120 mg/m²
120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 140 mg/m²
140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 160 mg/m²
160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
| Group | Source count |
|---|---|
| BT062 40 mg/m² | 4 |
| BT062 50 mg/m² | 3 |
| BT062 65 mg/m² | 4 |
| BT062 80 mg/m² | 3 |
| BT062 100 mg/m² | 4 |
| BT062 120 mg/m² | 3 |
| BT062 140 mg/m² | 10 |
| BT062 160 mg/m² | 4 |
Reported measurements
BT062 plasma concentration Cycle 1 - Cmax
| Group | Source count |
|---|---|
| BT062 40 mg/m² | 4 |
| BT062 50 mg/m² | 3 |
| BT062 65 mg/m² | 4 |
| BT062 80 mg/m² | 3 |
| BT062 100 mg/m² | 3 |
| BT062 120 mg/m² | 3 |
| BT062 140 mg/m² | 9 |
| BT062 160 mg/m² | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BT062 40 mg/m² | 13409.0 | Not reported | 3725 | 15888 | Not reported |
| BT062 50 mg/m² | 10156.0 | Not reported | 7108 | 14028 | Not reported |
| BT062 65 mg/m² | 26229.0 | Not reported | 17114 | 58194 | Not reported |
| BT062 80 mg/m² | 21498.0 | Not reported | 18827 | 31112 | Not reported |
| BT062 100 mg/m² | 51593.0 | Not reported | 36526 | 93993 | Not reported |
| BT062 120 mg/m² | 61190.0 | Not reported | 29640 | 66623 | Not reported |
| BT062 140 mg/m² | 48463.0 | Not reported | 32175 | 70734 | Not reported |
| BT062 160 mg/m² | 62876.5 | Not reported | 47149 | 78604 | Not reported |
BT062 plasma concentration Cycle 4 - Cmax
| Group | Source count |
|---|---|
| BT062 40 mg/m² | 1 |
| BT062 50 mg/m² | 1 |
| BT062 65 mg/m² | 2 |
| BT062 80 mg/m² | 1 |
| BT062 100 mg/m² | 1 |
| BT062 120 mg/m² | 2 |
| BT062 140 mg/m² | 1 |
| BT062 160 mg/m² | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BT062 40 mg/m² | 9427.0 | Not reported | 9427 | 9427 | Not reported |
| BT062 50 mg/m² | 14193.0 | Not reported | 14193 | 14193 | Not reported |
| BT062 65 mg/m² | 27770.5 | Not reported | 23740 | 31801 | Not reported |
| BT062 80 mg/m² | 38144.0 | Not reported | 38144 | 38144 | Not reported |
| BT062 100 mg/m² | 92046.0 | Not reported | 92046 | 92046 | Not reported |
| BT062 120 mg/m² | 96178.0 | Not reported | 42123 | 150233 | Not reported |
| BT062 140 mg/m² | 50073.0 | Not reported | 50073 | 50073 | Not reported |
| BT062 160 mg/m² | 79248.0 | Not reported | 79248 | 79248 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3725
- upper Limit
- 15888
- value
- 13409.0
- group Id
- OG001
- lower Limit
- 7108
- upper Limit
- 14028
- value
- 10156.0
- group Id
- OG002
- lower Limit
- 17114
- upper Limit
- 58194
- value
- 26229.0
- group Id
- OG003
- lower Limit
- 18827
- upper Limit
- 31112
- value
- 21498.0
- group Id
- OG004
- lower Limit
- 36526
- upper Limit
- 93993
- value
- 51593.0
- group Id
- OG005
- lower Limit
- 29640
- upper Limit
- 66623
- value
- 61190.0
- group Id
- OG006
- lower Limit
- 32175
- upper Limit
- 70734
- value
- 48463.0
- group Id
- OG007
- lower Limit
- 47149
- upper Limit
- 78604
- value
- 62876.5
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 2
- units
- Participants
- title
- BT062 plasma concentration Cycle 1 - Cmax
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9427
- upper Limit
- 9427
- value
- 9427.0
- group Id
- OG001
- lower Limit
- 14193
- upper Limit
- 14193
- value
- 14193.0
- group Id
- OG002
- lower Limit
- 23740
- upper Limit
- 31801
- value
- 27770.5
- group Id
- OG003
- lower Limit
- 38144
- upper Limit
- 38144
- value
- 38144.0
- group Id
- OG004
- lower Limit
- 92046
- upper Limit
- 92046
- value
- 92046.0
- group Id
- OG005
- lower Limit
- 42123
- upper Limit
- 150233
- value
- 96178.0
- group Id
- OG006
- lower Limit
- 50073
- upper Limit
- 50073
- value
- 50073.0
- group Id
- OG007
- lower Limit
- 79248
- upper Limit
- 79248
- value
- 79248.0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- units
- Participants
- title
- BT062 plasma concentration Cycle 4 - Cmax
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 4
- units
- Participants
- description
- Multi-dose Pharmacokinetics properties of BT062 after intravenous (IV) Administration of escalating doses of BT062 as assessed by measuring intact BT062 conjugate. Please note that not all subjects reached Cycle 4 due to early termination . A lower number of samples could be analyzed for Cycle 4.
- dispersion Type
- Full Range
- groups
- description
- 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- OG000
- title
- BT062 40 mg/m²
- description
- 50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- OG001
- title
- BT062 50 mg/m²
- description
- 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- OG002
- title
- BT062 65 mg/m²
- description
- 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- OG003
- title
- BT062 80 mg/m²
- description
- 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- OG004
- title
- BT062 100 mg/m²
- description
- 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- OG005
- title
- BT062 120 mg/m²
- description
- 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- OG006
- title
- BT062 140 mg/m²
- description
- 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- OG007
- title
- BT062 160 mg/m²
- param Type
- MEDIAN
- population Description
- Safety Population: The Safety population included all subjects who were enrolled and received at least 1 dose of BT062 (n = 35).
- reporting Status
- POSTED
- time Frame
- Starting with first study drug administration until 30-day follow-up visit (average 4.99 months).
- title
- Multi-dose Pharmacokinetics Properties of BT062 - Cmax
- type
- SECONDARY
- unit Of Measure
- ng/ml
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Preserved source evidence · Not medical advice