TriangleNCT00701103 · OUTCOME
Area Under the Time-concentration Curve From 0 to Infinity Hours (AUC0-∞) of Dalotuzumab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- mg*hr/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion
What was measured
AUC0-∞ represents the total drug exposure over time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion. For infusions \>1 hour in duration, an additional sample was obtained at the mid-point of the infusion.
Analysis population: The population consisted of all evaluable participants who received \>90% of intended drug volume and had AUC0-last pharmacokinetic measurements at Baseline and at least once during treatment.
Groups in this outcome
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
| Group | Source count |
|---|---|
| Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL) | 5 |
| Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL) | 3 |
| Dalotuzumab 5 mg/kg Q1W (10 mg/mL) | 8 |
| Dalotuzumab 10 mg/kg Q1W (10 mg/mL) | 6 |
| Dalotuzumab 10 mg/kg Q1W (20 mg/mL) | 3 |
| Dalotuzumab 15 mg/kg Q1W (10 mg/mL) | 6 |
| Dalotuzumab 15 mg/kg Q1W (20 mg/mL) | 8 |
| Dalotuzumab 20 mg/kg Q1W (10 mg/mL) | 7 |
| Dalotuzumab 20 mg/kg Q1W (20 mg/mL) | 9 |
| Dalotuzumab 20 mg/kg Q2W (20 mg/mL) | 11 |
| Dalotuzumab 30 mg/kg Q3W (20 mg/mL) | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL) | 1.6 | 0.4 | Not reported | Not reported | Not reported |
| Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL) | 3.7 | 1.1 | Not reported | Not reported | Not reported |
| Dalotuzumab 5 mg/kg Q1W (10 mg/mL) | 12.9 | 4.4 | Not reported | Not reported | Not reported |
| Dalotuzumab 10 mg/kg Q1W (10 mg/mL) | 28.9 | 10.4 | Not reported | Not reported | Not reported |
| Dalotuzumab 10 mg/kg Q1W (20 mg/mL) | 18.4 | 4.1 | Not reported | Not reported | Not reported |
| Dalotuzumab 15 mg/kg Q1W (10 mg/mL) | 39.4 | 14.5 | Not reported | Not reported | Not reported |
| Dalotuzumab 15 mg/kg Q1W (20 mg/mL) | 28.8 | 8.8 | Not reported | Not reported | Not reported |
| Dalotuzumab 20 mg/kg Q1W (10 mg/mL) | 52.7 | 19.2 | Not reported | Not reported | Not reported |
| Dalotuzumab 20 mg/kg Q1W (20 mg/mL) | 44.3 | 20.0 | Not reported | Not reported | Not reported |
| Dalotuzumab 20 mg/kg Q2W (20 mg/mL) | 45.9 | 14.4 | Not reported | Not reported | Not reported |
| Dalotuzumab 30 mg/kg Q3W (20 mg/mL) | 92.6 | 29.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.4
- value
- 1.6
- group Id
- OG001
- spread
- 1.1
- value
- 3.7
- group Id
- OG002
- spread
- 4.4
- value
- 12.9
- group Id
- OG003
- spread
- 10.4
- value
- 28.9
- group Id
- OG004
- spread
- 4.1
- value
- 18.4
- group Id
- OG005
- spread
- 14.5
- value
- 39.4
- group Id
- OG006
- spread
- 8.8
- value
- 28.8
- group Id
- OG007
- spread
- 19.2
- value
- 52.7
- group Id
- OG008
- spread
- 20.0
- value
- 44.3
- group Id
- OG009
- spread
- 14.4
- value
- 45.9
- group Id
- OG010
- spread
- 29.8
- value
- 92.6
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 11
- group Id
- OG010
- value
- 11
- units
- Participants
- description
- AUC0-∞ represents the total drug exposure over time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion. For infusions \>1 hour in duration, an additional sample was obtained at the mid-point of the infusion.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
- id
- OG000
- title
- Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
- description
- Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
- id
- OG001
- title
- Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
- description
- Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
- id
- OG002
- title
- Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
- description
- Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
- id
- OG003
- title
- Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
- description
- Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
- id
- OG004
- title
- Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
- description
- Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
- id
- OG005
- title
- Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
- description
- Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
- id
- OG006
- title
- Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
- description
- Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
- id
- OG007
- title
- Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
- description
- Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
- id
- OG008
- title
- Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
- description
- Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
- id
- OG009
- title
- Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
- description
- Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
- id
- OG010
- title
- Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
- param Type
- MEAN
- population Description
- The population consisted of all evaluable participants who received \>90% of intended drug volume and had AUC0-last pharmacokinetic measurements at Baseline and at least once during treatment.
- reporting Status
- POSTED
- time Frame
- Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion
- title
- Area Under the Time-concentration Curve From 0 to Infinity Hours (AUC0-∞) of Dalotuzumab
- type
- PRIMARY
- unit Of Measure
- mg*hr/mL
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Preserved source evidence · Not medical advice