TriangleNCT00819169 · OUTCOME
To Evaluate the Concentration Level of AMG 655
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- μg/mL
- Interval / dispersion
- Full Range
- Time frame
- Cycle 1 Day 1 end of infusion; Cycle 3 Day 1 end of infusion (each cycle is 28 days, each infusion is up to 1 hour)
What was measured
Median, minimum, and maximum concentration of AMG 655 at specified time points.
Analysis population: PK population = All subjects in the full analysis set who underwent blood sampling for PK evaluation during the study.
Groups in this outcome
Part 1 Cohort 1
AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
Part 1 Cohort 2
AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
Part 1 Cohort 3
AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
Part 2 Cohort 1
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
Part 2 Cohort 2
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC)
Part 2 Cohort 3
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC)
Part 2 Cohort 4
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
Part 2 Cohort 5
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
Part 2 Cohort 6
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
| Group | Source count |
|---|---|
| Part 1 Cohort 1 | 3 |
| Part 1 Cohort 2 | 2 |
| Part 1 Cohort 3 | 2 |
| Part 2 Cohort 1 | 13 |
| Part 2 Cohort 2 | 7 |
| Part 2 Cohort 3 | 14 |
| Part 2 Cohort 4 | 14 |
| Part 2 Cohort 5 | 7 |
| Part 2 Cohort 6 | 13 |
Reported measurements
Cycle 1-End of Infusion
| Group | Source count |
|---|---|
| Part 1 Cohort 1 | 3 |
| Part 1 Cohort 2 | 1 |
| Part 1 Cohort 3 | 2 |
| Part 2 Cohort 1 | 2 |
| Part 2 Cohort 2 | 1 |
| Part 2 Cohort 3 | 10 |
| Part 2 Cohort 4 | 11 |
| Part 2 Cohort 5 | 4 |
| Part 2 Cohort 6 | 13 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Cohort 1 | 17.5 | Not reported | 17.3 | 19.4 | Not reported |
| Part 1 Cohort 2 | 59.0 | Not reported | 59.0 | 59.0 | Not reported |
| Part 1 Cohort 3 | 313 | Not reported | 261 | 365 | Not reported |
| Part 2 Cohort 1 | 244 | Not reported | 240 | 247 | Not reported |
| Part 2 Cohort 2 | 266 | Not reported | 266 | 266 | Not reported |
| Part 2 Cohort 3 | 240 | Not reported | 115 | 319 | Not reported |
| Part 2 Cohort 4 | 224 | Not reported | 130 | 293 | Not reported |
| Part 2 Cohort 5 | 327 | Not reported | 275 | 341 | Not reported |
| Part 2 Cohort 6 | 247 | Not reported | 91.3 | 392 | Not reported |
Cycle 3-End of infusion
| Group | Source count |
|---|---|
| Part 1 Cohort 1 | 1 |
| Part 1 Cohort 2 | 1 |
| Part 1 Cohort 3 | 1 |
| Part 2 Cohort 1 | 1 |
| Part 2 Cohort 2 | 0 |
| Part 2 Cohort 3 | 4 |
| Part 2 Cohort 4 | 1 |
| Part 2 Cohort 5 | 2 |
| Part 2 Cohort 6 | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Cohort 1 | 23.6 | Not reported | 23.6 | 23.6 | Not reported |
| Part 1 Cohort 2 | 62.3 | Not reported | 62.3 | 62.3 | Not reported |
| Part 1 Cohort 3 | 302 | Not reported | 302 | 302 | Not reported |
| Part 2 Cohort 1 | 448 | Not reported | 448 | 448 | Not reported |
| Part 2 Cohort 3 | 311 | Not reported | 233 | 380 | Not reported |
| Part 2 Cohort 4 | 253 | Not reported | 253 | 253 | Not reported |
| Part 2 Cohort 5 | 423 | Not reported | 356 | 490 | Not reported |
| Part 2 Cohort 6 | 371 | Not reported | 328 | 466 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.3
- upper Limit
- 19.4
- value
- 17.5
- group Id
- OG001
- lower Limit
- 59.0
- upper Limit
- 59.0
- value
- 59.0
- group Id
- OG002
- lower Limit
- 261
- upper Limit
- 365
- value
- 313
- group Id
- OG003
- lower Limit
- 240
- upper Limit
- 247
- value
- 244
- group Id
- OG004
- lower Limit
- 266
- upper Limit
- 266
- value
- 266
- group Id
- OG005
- lower Limit
- 115
- upper Limit
- 319
- value
- 240
- group Id
- OG006
- lower Limit
- 130
- upper Limit
- 293
- value
- 224
- group Id
- OG007
- lower Limit
- 275
- upper Limit
- 341
- value
- 327
- group Id
- OG008
- lower Limit
- 91.3
- upper Limit
- 392
- value
- 247
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 13
- units
- Participants
- title
- Cycle 1-End of Infusion
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23.6
- upper Limit
- 23.6
- value
- 23.6
- group Id
- OG001
- lower Limit
- 62.3
- upper Limit
- 62.3
- value
- 62.3
- group Id
- OG002
- lower Limit
- 302
- upper Limit
- 302
- value
- 302
- group Id
- OG003
- lower Limit
- 448
- upper Limit
- 448
- value
- 448
- group Id
- OG005
- lower Limit
- 233
- upper Limit
- 380
- value
- 311
- group Id
- OG006
- lower Limit
- 253
- upper Limit
- 253
- value
- 253
- group Id
- OG007
- lower Limit
- 356
- upper Limit
- 490
- value
- 423
- group Id
- OG008
- lower Limit
- 328
- upper Limit
- 466
- value
- 371
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 4
- units
- Participants
- title
- Cycle 3-End of infusion
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 14
- group Id
- OG006
- value
- 14
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 13
- units
- Participants
- description
- Median, minimum, and maximum concentration of AMG 655 at specified time points.
- dispersion Type
- Full Range
- groups
- description
- AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
- id
- OG000
- title
- Part 1 Cohort 1
- description
- AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
- id
- OG001
- title
- Part 1 Cohort 2
- description
- AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
- id
- OG002
- title
- Part 1 Cohort 3
- description
- AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
- id
- OG003
- title
- Part 2 Cohort 1
- description
- AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC)
- id
- OG004
- title
- Part 2 Cohort 2
- description
- AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC)
- id
- OG005
- title
- Part 2 Cohort 3
- description
- AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
- id
- OG006
- title
- Part 2 Cohort 4
- description
- AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
- id
- OG007
- title
- Part 2 Cohort 5
- description
- AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
- id
- OG008
- title
- Part 2 Cohort 6
- param Type
- MEDIAN
- population Description
- PK population = All subjects in the full analysis set who underwent blood sampling for PK evaluation during the study.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 end of infusion; Cycle 3 Day 1 end of infusion (each cycle is 28 days, each infusion is up to 1 hour)
- title
- To Evaluate the Concentration Level of AMG 655
- type
- SECONDARY
- unit Of Measure
- μg/mL
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Preserved source evidence · Not medical advice