TriangleNCT00701103 · OUTCOME
Mean Serum Clearance of Dalotuzumab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- mL/min/kg
- 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
Clearance is defined as the volume of serum from which study drug was completely removed per unit of time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: pre-dose; 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 mean serum clearance 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) | 0.013 | 0.004 | Not reported | Not reported | Not reported |
| Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL) | 0.012 | 0.003 | Not reported | Not reported | Not reported |
| Dalotuzumab 5 mg/kg Q1W (10 mg/mL) | 0.007 | 0.003 | Not reported | Not reported | Not reported |
| Dalotuzumab 10 mg/kg Q1W (10 mg/mL) | 0.006 | 0.002 | Not reported | Not reported | Not reported |
| Dalotuzumab 10 mg/kg Q1W (20 mg/mL) | 0.009 | 0.002 | Not reported | Not reported | Not reported |
| Dalotuzumab 15 mg/kg Q1W (10 mg/mL) | 0.007 | 0.004 | Not reported | Not reported | Not reported |
| Dalotuzumab 15 mg/kg Q1W (20 mg/mL) | 0.010 | 0.004 | Not reported | Not reported | Not reported |
| Dalotuzumab 20 mg/kg Q1W (10 mg/mL) | 0.007 | 0.003 | Not reported | Not reported | Not reported |
| Dalotuzumab 20 mg/kg Q1W (20 mg/mL) | 0.009 | 0.004 | Not reported | Not reported | Not reported |
| Dalotuzumab 20 mg/kg Q2W (20 mg/mL) | 0.008 | 0.003 | Not reported | Not reported | Not reported |
| Dalotuzumab 30 mg/kg Q3W (20 mg/mL) | 0.006 | 0.003 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.004
- value
- 0.013
- group Id
- OG001
- spread
- 0.003
- value
- 0.012
- group Id
- OG002
- spread
- 0.003
- value
- 0.007
- group Id
- OG003
- spread
- 0.002
- value
- 0.006
- group Id
- OG004
- spread
- 0.002
- value
- 0.009
- group Id
- OG005
- spread
- 0.004
- value
- 0.007
- group Id
- OG006
- spread
- 0.004
- value
- 0.010
- group Id
- OG007
- spread
- 0.003
- value
- 0.007
- group Id
- OG008
- spread
- 0.004
- value
- 0.009
- group Id
- OG009
- spread
- 0.003
- value
- 0.008
- group Id
- OG010
- spread
- 0.003
- value
- 0.006
- 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
- Clearance is defined as the volume of serum from which study drug was completely removed per unit of time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: pre-dose; 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 mean serum clearance 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
- Mean Serum Clearance of Dalotuzumab
- type
- PRIMARY
- unit Of Measure
- mL/min/kg
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Preserved source evidence · Not medical advice