TriangleNCT00701103 · OUTCOME
Percentage of Participants Who Developed a Serum Human-anti-humanized-antibody (HAHA) Response to Dalotuzumab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 2 years
What was measured
It is thought that the formation of HAHAs may block efficacy by prematurely clearing dalotuzumab and limit the possibility of future dalotuzumab therapy. Blood samples for the measurement of serum levels of HAHAs were obtained prior to treatment with dalotuzumab, and pre-dose Week 2 (Q1W), pre-dose Week 3 (Q2W), pre-dose Week 4 (QW3), pre-dose Week 5 (Q1W/Q2W), pre-dose Week 7 (Q2W/Q3W), pre-dose Week 9 (Q2W), pre-dose Week 10 (QW3) and pre-dose every 4 subsequent weeks and end of treatment (post-study: 4 weeks after last dose of study drug).
Analysis population: The population consisted of all participants who received \>90% of intended drug volume and had 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) | 6 |
| 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) | 40 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 5 mg/kg Q1W (10 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 10 mg/kg Q1W (10 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 10 mg/kg Q1W (20 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 15 mg/kg Q1W (10 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 15 mg/kg Q1W (20 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 20 mg/kg Q1W (10 mg/mL) | 14 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 20 mg/kg Q1W (20 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 20 mg/kg Q2W (20 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dalotuzumab 30 mg/kg Q3W (20 mg/mL) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 14
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- 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
- 6
- 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
- It is thought that the formation of HAHAs may block efficacy by prematurely clearing dalotuzumab and limit the possibility of future dalotuzumab therapy. Blood samples for the measurement of serum levels of HAHAs were obtained prior to treatment with dalotuzumab, and pre-dose Week 2 (Q1W), pre-dose Week 3 (Q2W), pre-dose Week 4 (QW3), pre-dose Week 5 (Q1W/Q2W), pre-dose Week 7 (Q2W/Q3W), pre-dose Week 9 (Q2W), pre-dose Week 10 (QW3) and pre-dose every 4 subsequent weeks and end of treatment (post-study: 4 weeks after last dose of study drug).
- 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
- NUMBER
- population Description
- The population consisted of all participants who received \>90% of intended drug volume and had measurements at Baseline and at least once during treatment.
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Percentage of Participants Who Developed a Serum Human-anti-humanized-antibody (HAHA) Response to Dalotuzumab
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice