TriangleNCT02675452 · OUTCOME
AUC From Time 0 to 168 Hours (AUC0-168) of AMG 176 (Parts 1B, 3 [Cohort 4], 3B, 3C, and 3D)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hour*ng/mL
- Interval / dispersion
- Full Range
- Time frame
- Parts 1B, 3B, 3C, and 3 (cohort 4): Cycle 1 day 1 pre, EOI, 1, 2, 3, 5, and 7 hrs EOI, cycle 1 day 8 pre, EOI; Part 3d also cycle 1 day 15 pre and EOI
What was measured
Plasma concentrations of AMG 176 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ of 5.00 ng/mL were set to zero before data analysis.
Analysis population: The PK analysis set included all participants who had received at least 1 dose of AMG 176 and had at least 1 PK sample collected. AUC0-168 was pre-specified in Parts 1B, 3 (Cohort 4), 3B, 3C, and 3D and participants with data available at each time point are presented.
Groups in this outcome
Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose F QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose G QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose H QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose I QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 3 Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW
Japanese participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose F QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 3B Cohort 1 (AML): AMG 176 Dose E QW
Participants with AML received AMG 176 Dose E QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW
Participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose F QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW
Participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose G QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW
Japanese participants with AML received AMG 176 Dose E QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole
Participants with AML received AMG 176 Dose D QW. AMG 176 was administered as an IV infusion in a 4-week cycle. They also received 200 mg itraconazole QD for 7 days in week 1.
| Group | Source count |
|---|---|
| Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW | 3 |
| Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW | 3 |
| Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW | 1 |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 3 |
| Part 3 Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW | 2 |
| Part 3B Cohort 1 (AML): AMG 176 Dose E QW | 4 |
| Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW | 2 |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 3 |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 4 |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 8 |
Reported measurements
Cycle 1 day 1
| Group | Source count |
|---|---|
| Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW | 3 |
| Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW | 2 |
| Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW | 1 |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 2 |
| Part 3 Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW | 2 |
| Part 3B Cohort 1 (AML): AMG 176 Dose E QW | 4 |
| Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW | 2 |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 3 |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 4 |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW | 133000 | Not reported | 75600 | 344000 | Not reported |
| Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW | 152000 | Not reported | 123000 | 181000 | Not reported |
| Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW | 108000 | Not reported | 108000 | 108000 | Not reported |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 104000 | Not reported | 98300 | 110000 | Not reported |
| Part 3 Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW | 199000 | Not reported | 183000 | 214000 | Not reported |
| Part 3B Cohort 1 (AML): AMG 176 Dose E QW | 82200 | Not reported | 76000 | 180000 | Not reported |
| Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW | 74400 | Not reported | 46800 | 102000 | Not reported |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 83700 | Not reported | 41200 | 106000 | Not reported |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 203000 | Not reported | 138000 | 306000 | Not reported |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 12800 | Not reported | 9390 | 22200 | Not reported |
Cycle 1 day 8
| Group | Source count |
|---|---|
| Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW | 3 |
| Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW | 3 |
| Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW | 1 |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 3 |
| Part 3 Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW | 2 |
| Part 3B Cohort 1 (AML): AMG 176 Dose E QW | 4 |
| Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW | 2 |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 3 |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 4 |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW | 185000 | Not reported | 135000 | 271000 | Not reported |
| Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW | 348000 | Not reported | 309000 | 361000 | Not reported |
| Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW | 345000 | Not reported | 345000 | 345000 | Not reported |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 405000 | Not reported | 191000 | 1360000 | Not reported |
| Part 3 Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW | 296000 | Not reported | 216000 | 376000 | Not reported |
| Part 3B Cohort 1 (AML): AMG 176 Dose E QW | 34800 | Not reported | 21000 | 62300 | Not reported |
| Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW | 450000 | Not reported | 446000 | 455000 | Not reported |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 272000 | Not reported | 227000 | 619000 | Not reported |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 153000 | Not reported | 65000 | 252000 | Not reported |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 25700 | Not reported | 16600 | 28600 | Not reported |
Cycle 1 day 15
| Group | Source count |
|---|---|
| Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW | 0 |
| Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW | 0 |
| Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW | 0 |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 0 |
| Part 3 Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW | 0 |
| Part 3B Cohort 1 (AML): AMG 176 Dose E QW | 0 |
| Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW | 0 |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 0 |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 0 |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 14600 | Not reported | 3530 | 95400 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 75600
- upper Limit
- 344000
- value
- 133000
- group Id
- OG001
- lower Limit
- 123000
- upper Limit
- 181000
- value
- 152000
- group Id
- OG002
- lower Limit
- 108000
- upper Limit
- 108000
- value
- 108000
- group Id
- OG003
- lower Limit
- 98300
- upper Limit
- 110000
- value
- 104000
- group Id
- OG004
- lower Limit
- 183000
- upper Limit
- 214000
- value
- 199000
- group Id
- OG005
- lower Limit
- 76000
- upper Limit
- 180000
- value
- 82200
- group Id
- OG006
- lower Limit
- 46800
- upper Limit
- 102000
- value
- 74400
- group Id
- OG007
- lower Limit
- 41200
- upper Limit
- 106000
- value
- 83700
- group Id
- OG008
- lower Limit
- 138000
- upper Limit
- 306000
- value
- 203000
- group Id
- OG009
- lower Limit
- 9390
- upper Limit
- 22200
- value
- 12800
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 8
- units
- Participants
- title
- Cycle 1 day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 135000
- upper Limit
- 271000
- value
- 185000
- group Id
- OG001
- lower Limit
- 309000
- upper Limit
- 361000
- value
- 348000
- group Id
- OG002
- lower Limit
- 345000
- upper Limit
- 345000
- value
- 345000
- group Id
- OG003
- lower Limit
- 191000
- upper Limit
- 1360000
- value
- 405000
- group Id
- OG004
- lower Limit
- 216000
- upper Limit
- 376000
- value
- 296000
- group Id
- OG005
- lower Limit
- 21000
- upper Limit
- 62300
- value
- 34800
- group Id
- OG006
- lower Limit
- 446000
- upper Limit
- 455000
- value
- 450000
- group Id
- OG007
- lower Limit
- 227000
- upper Limit
- 619000
- value
- 272000
- group Id
- OG008
- lower Limit
- 65000
- upper Limit
- 252000
- value
- 153000
- group Id
- OG009
- lower Limit
- 16600
- upper Limit
- 28600
- value
- 25700
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 3
- units
- Participants
- title
- Cycle 1 day 8
- categories
- measurements
- group Id
- OG009
- lower Limit
- 3530
- upper Limit
- 95400
- value
- 14600
- denoms
- counts
- group Id
- OG000
- value
- 0
- 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
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 6
- units
- Participants
- title
- Cycle 1 day 15
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 8
- units
- Participants
- description
- Plasma concentrations of AMG 176 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ of 5.00 ng/mL were set to zero before data analysis.
- dispersion Type
- Full Range
- groups
- description
- Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose F QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG000
- title
- Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW
- description
- Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose G QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG001
- title
- Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW
- description
- Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose H QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG002
- title
- Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW
- description
- Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose I QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG003
- title
- Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW
- description
- Japanese participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose F QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG004
- title
- Part 3 Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW
- description
- Participants with AML received AMG 176 Dose E QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG005
- title
- Part 3B Cohort 1 (AML): AMG 176 Dose E QW
- description
- Participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose F QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG006
- title
- Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW
- description
- Participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose G QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG007
- title
- Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW
- description
- Japanese participants with AML received AMG 176 Dose E QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG008
- title
- Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW
- description
- Participants with AML received AMG 176 Dose D QW. AMG 176 was administered as an IV infusion in a 4-week cycle. They also received 200 mg itraconazole QD for 7 days in week 1.
- id
- OG009
- title
- Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole
- param Type
- MEDIAN
- population Description
- The PK analysis set included all participants who had received at least 1 dose of AMG 176 and had at least 1 PK sample collected. AUC0-168 was pre-specified in Parts 1B, 3 (Cohort 4), 3B, 3C, and 3D and participants with data available at each time point are presented.
- reporting Status
- POSTED
- time Frame
- Parts 1B, 3B, 3C, and 3 (cohort 4): Cycle 1 day 1 pre, EOI, 1, 2, 3, 5, and 7 hrs EOI, cycle 1 day 8 pre, EOI; Part 3d also cycle 1 day 15 pre and EOI
- title
- AUC From Time 0 to 168 Hours (AUC0-168) of AMG 176 (Parts 1B, 3 [Cohort 4], 3B, 3C, and 3D)
- type
- PRIMARY
- unit Of Measure
- hour*ng/mL
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Preserved source evidence · Not medical advice