TriangleNCT00819169 · OUTCOME
To Evaluate the Concentration Level of AMG 479
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 479 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 | 9 |
| 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 | 8 |
| Part 2 Cohort 4 | 12 |
| Part 2 Cohort 5 | 5 |
| Part 2 Cohort 6 | 13 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Cohort 1 | 272 | Not reported | 198 | 279 | Not reported |
| Part 1 Cohort 2 | 268 | Not reported | 268 | 268 | Not reported |
| Part 1 Cohort 3 | 303 | Not reported | 257 | 349 | Not reported |
| Part 2 Cohort 1 | 215 | Not reported | 193 | 237 | Not reported |
| Part 2 Cohort 2 | 297 | Not reported | 297 | 297 | Not reported |
| Part 2 Cohort 3 | 227 | Not reported | 130 | 634 | Not reported |
| Part 2 Cohort 4 | 236 | Not reported | 121 | 391 | Not reported |
| Part 2 Cohort 5 | 324 | Not reported | 248 | 439 | Not reported |
| Part 2 Cohort 6 | 254 | Not reported | 169 | 445 | Not reported |
Cycle 3-End of Infusion
| Group | Source count |
|---|---|
| Part 1 Cohort 1 | 1 |
| Part 1 Cohort 2 | 0 |
| 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 | 3 |
| Part 2 Cohort 6 | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Cohort 1 | 308 | Not reported | 308 | 308 | Not reported |
| Part 1 Cohort 3 | 338 | Not reported | 338 | 338 | Not reported |
| Part 2 Cohort 1 | 404 | Not reported | 404 | 404 | Not reported |
| Part 2 Cohort 3 | 262 | Not reported | 205 | 364 | Not reported |
| Part 2 Cohort 4 | 249 | Not reported | 249 | 249 | Not reported |
| Part 2 Cohort 5 | 323 | Not reported | 300 | 381 | Not reported |
| Part 2 Cohort 6 | 365 | Not reported | 244 | 420 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 198
- upper Limit
- 279
- value
- 272
- group Id
- OG001
- lower Limit
- 268
- upper Limit
- 268
- value
- 268
- group Id
- OG002
- lower Limit
- 257
- upper Limit
- 349
- value
- 303
- group Id
- OG003
- lower Limit
- 193
- upper Limit
- 237
- value
- 215
- group Id
- OG004
- lower Limit
- 297
- upper Limit
- 297
- value
- 297
- group Id
- OG005
- lower Limit
- 130
- upper Limit
- 634
- value
- 227
- group Id
- OG006
- lower Limit
- 121
- upper Limit
- 391
- value
- 236
- group Id
- OG007
- lower Limit
- 248
- upper Limit
- 439
- value
- 324
- group Id
- OG008
- lower Limit
- 169
- upper Limit
- 445
- value
- 254
- 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
- 8
- group Id
- OG006
- value
- 12
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 13
- units
- Participants
- title
- Cycle 1-End of infusion
- categories
- measurements
- group Id
- OG000
- lower Limit
- 308
- upper Limit
- 308
- value
- 308
- group Id
- OG002
- lower Limit
- 338
- upper Limit
- 338
- value
- 338
- group Id
- OG003
- lower Limit
- 404
- upper Limit
- 404
- value
- 404
- group Id
- OG005
- lower Limit
- 205
- upper Limit
- 364
- value
- 262
- group Id
- OG006
- lower Limit
- 249
- upper Limit
- 249
- value
- 249
- group Id
- OG007
- lower Limit
- 300
- upper Limit
- 381
- value
- 323
- group Id
- OG008
- lower Limit
- 244
- upper Limit
- 420
- value
- 365
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- 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
- 3
- 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
- 9
- group Id
- OG008
- value
- 13
- units
- Participants
- description
- Median, minimum, and maximum concentration of AMG 479 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 479
- type
- SECONDARY
- unit Of Measure
- μg/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice