TriangleNCT02675452 · OUTCOME
AUC From Time 0 to 144 Hours (AUC0-144) of AMG 176 (Parts 1A, 3A [Cohorts 1, 2, and 3], and 4 [Cohorts 5A and 5B])
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 1A, 3A, and 4: Cycle 1 day 2 pre, EOI, 1, 2, 3, 5, and 7 hrs EOI, cycle 1 day 9 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. AUC0-144 was pre-specified in Parts 1A, 3A (Cohorts 1, 2, and 3) and 4 (Cohorts 5A and 5B) and participants with data available at each time point are presented.
Groups in this outcome
Part 1A Cohort 1 (MM): AMG 176 Dose A BIW
Participants with MM received AMG 176 Dose A BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1A Cohort 2 (MM): AMG 176 Dose B BIW
Participants with MM received AMG 176 Dose B IV BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1A Cohort 3 (MM): AMG 176 Dose C BIW
Participants with MM received AMG 176 Dose C BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1A Cohort 4 (MM): AMG 176 Dose D BIW
Participants with MM received AMG 176 Dose D BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1A Cohort 5 (MM): AMG 176 Dose E BIW
Participants with MM received AMG 176 Dose E BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1A Cohort 6 (MM): AMG 176 Dose G BIW
Participants with MM received AMG 176 Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose F BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose H BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW
Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose I BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 3 Cohort 1 (AML): AMG 176 Dose D BIW
Participants with AML received AMG 176 Dose D BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 3 Cohort 2 (AML): AMG 176 Dose E BIW
Participants with AML received AMG 176 Dose E BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 3 Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW
Participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose F BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine
Participants with AML received AMG 176 Dose E BIW. AMG 176 was administered as an IV infusion in a 4-week cycle. They also received 75 mg/m\^2 azacitidine SC or IV QD for 7 days in week 1.
Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine
Participants with AML received AMG 176 Dose E in cycle 1 week 1, then received Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle. They also received 75 mg/m\^2 azacitidine SC or IV QD for 7 days in week 1.
| Group | Source count |
|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 3 |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 3 |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 3 |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 2 |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 3 |
| Part 1A Cohort 6 (MM): AMG 176 Dose G BIW | 0 |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 2 |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 1 |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 2 |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 4 |
| Part 3 Cohort 1 (AML): AMG 176 Dose D BIW | 5 |
| Part 3 Cohort 2 (AML): AMG 176 Dose E BIW | 5 |
| Part 3 Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 3 |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 2 |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 6 |
Reported measurements
Cycle 1 day 2
| Group | Source count |
|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 3 |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 3 |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 3 |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 2 |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 3 |
| Part 1A Cohort 6 (MM): AMG 176 Dose G BIW | 0 |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 0 |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 1 |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 0 |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 1 |
| Part 3 Cohort 1 (AML): AMG 176 Dose D BIW | 5 |
| Part 3 Cohort 2 (AML): AMG 176 Dose E BIW | 5 |
| Part 3 Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 3 |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 2 |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 10800 | Not reported | 8190 | 20000 | Not reported |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 25300 | Not reported | 21100 | 30700 | Not reported |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 25700 | Not reported | 5660 | 33900 | Not reported |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 58900 | Not reported | 45800 | 72000 | Not reported |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 87600 | Not reported | 81200 | 115000 | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 277000 | Not reported | 277000 | 277000 | Not reported |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 385000 | Not reported | 385000 | 385000 | Not reported |
| Part 3 Cohort 1 (AML): AMG 176 Dose D BIW | 34600 | Not reported | 11500 | 74100 | Not reported |
| Part 3 Cohort 2 (AML): AMG 176 Dose E BIW | 81000 | Not reported | 51700 | 173000 | Not reported |
| Part 3 Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 122000 | Not reported | 51400 | 258000 | Not reported |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 63000 | Not reported | 0.00 | 126000 | Not reported |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 99300 | Not reported | 73600 | 508000 | Not reported |
Cycle 1 day 9
| Group | Source count |
|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 1 |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 3 |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 2 |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 1 |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 2 |
| Part 1A Cohort 6 (MM): AMG 176 Dose G BIW | 0 |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 2 |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 1 |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 2 |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 4 |
| Part 3 Cohort 1 (AML): AMG 176 Dose D BIW | 2 |
| Part 3 Cohort 2 (AML): AMG 176 Dose E BIW | 4 |
| Part 3 Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 0 |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 1 |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 540000 | Not reported | 540000 | 540000 | Not reported |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 124000 | Not reported | 119000 | 217000 | Not reported |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 234000 | Not reported | 225000 | 242000 | Not reported |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 202000 | Not reported | 202000 | 202000 | Not reported |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 435000 | Not reported | 379000 | 491000 | Not reported |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 134000 | Not reported | 20100 | 249000 | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 990000 | Not reported | 990000 | 990000 | Not reported |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 518000 | Not reported | 352000 | 684000 | Not reported |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 473000 | Not reported | 293000 | 838000 | Not reported |
| Part 3 Cohort 1 (AML): AMG 176 Dose D BIW | 432000 | Not reported | 59100 | 805000 | Not reported |
| Part 3 Cohort 2 (AML): AMG 176 Dose E BIW | 197000 | Not reported | 97800 | 313000 | Not reported |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 121000 | Not reported | 121000 | 121000 | Not reported |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 217000 | Not reported | 175000 | 284000 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8190
- upper Limit
- 20000
- value
- 10800
- group Id
- OG001
- lower Limit
- 21100
- upper Limit
- 30700
- value
- 25300
- group Id
- OG002
- lower Limit
- 5660
- upper Limit
- 33900
- value
- 25700
- group Id
- OG003
- lower Limit
- 45800
- upper Limit
- 72000
- value
- 58900
- group Id
- OG004
- lower Limit
- 81200
- upper Limit
- 115000
- value
- 87600
- group Id
- OG007
- lower Limit
- 277000
- upper Limit
- 277000
- value
- 277000
- group Id
- OG009
- lower Limit
- 385000
- upper Limit
- 385000
- value
- 385000
- group Id
- OG010
- lower Limit
- 11500
- upper Limit
- 74100
- value
- 34600
- group Id
- OG011
- lower Limit
- 51700
- upper Limit
- 173000
- value
- 81000
- group Id
- OG012
- lower Limit
- 51400
- upper Limit
- 258000
- value
- 122000
- group Id
- OG013
- lower Limit
- 0.00
- upper Limit
- 126000
- value
- 63000
- group Id
- OG014
- lower Limit
- 73600
- upper Limit
- 508000
- value
- 99300
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 5
- units
- Participants
- title
- Cycle 1 day 2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 540000
- upper Limit
- 540000
- value
- 540000
- group Id
- OG001
- lower Limit
- 119000
- upper Limit
- 217000
- value
- 124000
- group Id
- OG002
- lower Limit
- 225000
- upper Limit
- 242000
- value
- 234000
- group Id
- OG003
- lower Limit
- 202000
- upper Limit
- 202000
- value
- 202000
- group Id
- OG004
- lower Limit
- 379000
- upper Limit
- 491000
- value
- 435000
- group Id
- OG006
- lower Limit
- 20100
- upper Limit
- 249000
- value
- 134000
- group Id
- OG007
- lower Limit
- 990000
- upper Limit
- 990000
- value
- 990000
- group Id
- OG008
- lower Limit
- 352000
- upper Limit
- 684000
- value
- 518000
- group Id
- OG009
- lower Limit
- 293000
- upper Limit
- 838000
- value
- 473000
- group Id
- OG010
- lower Limit
- 59100
- upper Limit
- 805000
- value
- 432000
- group Id
- OG011
- lower Limit
- 97800
- upper Limit
- 313000
- value
- 197000
- group Id
- OG013
- lower Limit
- 121000
- upper Limit
- 121000
- value
- 121000
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 2
- group Id
- OG011
- value
- 4
- units
- Participants
- title
- Cycle 1 day 9
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 5
- 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 A BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG000
- title
- Part 1A Cohort 1 (MM): AMG 176 Dose A BIW
- description
- Participants with MM received AMG 176 Dose B IV BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG001
- title
- Part 1A Cohort 2 (MM): AMG 176 Dose B BIW
- description
- Participants with MM received AMG 176 Dose C BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG002
- title
- Part 1A Cohort 3 (MM): AMG 176 Dose C BIW
- description
- Participants with MM received AMG 176 Dose D BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG003
- title
- Part 1A Cohort 4 (MM): AMG 176 Dose D BIW
- description
- Participants with MM received AMG 176 Dose E BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG004
- title
- Part 1A Cohort 5 (MM): AMG 176 Dose E BIW
- description
- Participants with MM received AMG 176 Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG005
- title
- Part 1A Cohort 6 (MM): AMG 176 Dose G BIW
- description
- Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose F BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG006
- title
- Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW
- description
- Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG007
- title
- Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW
- description
- Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose H BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG008
- title
- Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW
- description
- Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose I BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG009
- title
- Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW
- description
- Participants with AML received AMG 176 Dose D BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG010
- title
- Part 3 Cohort 1 (AML): AMG 176 Dose D BIW
- description
- Participants with AML received AMG 176 Dose E BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG011
- title
- Part 3 Cohort 2 (AML): AMG 176 Dose E BIW
- 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. AUC0-144 was pre-specified in Parts 1A, 3A (Cohorts 1, 2, and 3) and 4 (Cohorts 5A and 5B) and participants with data available at each time point are presented.
- reporting Status
- POSTED
- time Frame
- Parts 1A, 3A, and 4: Cycle 1 day 2 pre, EOI, 1, 2, 3, 5, and 7 hrs EOI, cycle 1 day 9 pre and EOI
- title
- AUC From Time 0 to 144 Hours (AUC0-144) of AMG 176 (Parts 1A, 3A [Cohorts 1, 2, and 3], and 4 [Cohorts 5A and 5B])
- type
- PRIMARY
- unit Of Measure
- hour*ng/mL
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Preserved source evidence · Not medical advice