TriangleNCT02675452 · OUTCOME
Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) 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 1 pre, EOI, 1, 2, 3, 5, and 7 hrs EOI, cycle 1 day 8 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. AUC0-24 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 | 4 |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 3 |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 3 |
| Part 1A Cohort 6 (MM): AMG 176 Dose G BIW | 2 |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 3 |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 4 |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 3 |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 2 |
| 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 | 3 |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 6 |
Reported measurements
Cycle 1 day 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 | 4 |
| 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 | 2 |
| 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 | 2 |
| 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 | 3 |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 6230 | Not reported | 6100 | 11500 | Not reported |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 13700 | Not reported | 11900 | 16500 | Not reported |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 13900 | Not reported | 3570 | 18700 | Not reported |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 32700 | Not reported | 21300 | 44100 | Not reported |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 48500 | Not reported | 36700 | 60900 | Not reported |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 26700 | Not reported | 11000 | 42400 | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 128000 | Not reported | 40100 | 216000 | Not reported |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 47700 | Not reported | 38500 | 56800 | Not reported |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 38500 | Not reported | 24100 | 52800 | Not reported |
| Part 3 Cohort 1 (AML): AMG 176 Dose D BIW | 18300 | Not reported | 10000 | 28900 | Not reported |
| Part 3 Cohort 2 (AML): AMG 176 Dose E BIW | 44700 | Not reported | 17100 | 66100 | Not reported |
| Part 3 Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 64900 | Not reported | 35900 | 83900 | Not reported |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 30100 | Not reported | 26300 | 50200 | Not reported |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 32000 | Not reported | 22000 | 37100 | Not reported |
Cycle 1 day 8
| Group | Source count |
|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 0 |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 0 |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 1 |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 1 |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 1 |
| 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 | 4 |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 3 |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 2 |
| Part 3 Cohort 1 (AML): AMG 176 Dose D BIW | 2 |
| Part 3 Cohort 2 (AML): AMG 176 Dose E BIW | 5 |
| 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 | 3 |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 21100 | Not reported | 21100 | 21100 | Not reported |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 3240 | Not reported | 3240 | 3240 | Not reported |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 130000 | Not reported | 130000 | 130000 | Not reported |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 52300 | Not reported | 20600 | 84000 | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 128000 | Not reported | 110000 | 345000 | Not reported |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 118000 | Not reported | 111000 | 191000 | Not reported |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 176000 | Not reported | 84600 | 267000 | Not reported |
| Part 3 Cohort 1 (AML): AMG 176 Dose D BIW | 52600 | Not reported | 31000 | 74300 | Not reported |
| Part 3 Cohort 2 (AML): AMG 176 Dose E BIW | 51800 | Not reported | 48700 | 91300 | Not reported |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 23600 | Not reported | 0.00 | 28300 | Not reported |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 86800 | Not reported | 33900 | 133000 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6100
- upper Limit
- 11500
- value
- 6230
- group Id
- OG001
- lower Limit
- 11900
- upper Limit
- 16500
- value
- 13700
- group Id
- OG002
- lower Limit
- 3570
- upper Limit
- 18700
- value
- 13900
- group Id
- OG003
- lower Limit
- 21300
- upper Limit
- 44100
- value
- 32700
- group Id
- OG004
- lower Limit
- 36700
- upper Limit
- 60900
- value
- 48500
- group Id
- OG006
- lower Limit
- 11000
- upper Limit
- 42400
- value
- 26700
- group Id
- OG007
- lower Limit
- 40100
- upper Limit
- 216000
- value
- 128000
- group Id
- OG008
- lower Limit
- 38500
- upper Limit
- 56800
- value
- 47700
- group Id
- OG009
- lower Limit
- 24100
- upper Limit
- 52800
- value
- 38500
- group Id
- OG010
- lower Limit
- 10000
- upper Limit
- 28900
- value
- 18300
- group Id
- OG011
- lower Limit
- 17100
- upper Limit
- 66100
- value
- 44700
- group Id
- OG012
- lower Limit
- 35900
- upper Limit
- 83900
- value
- 64900
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 5
- units
- Participants
- title
- Cycle 1 day 1
- categories
- measurements
- group Id
- OG002
- lower Limit
- 21100
- upper Limit
- 21100
- value
- 21100
- group Id
- OG003
- lower Limit
- 3240
- upper Limit
- 3240
- value
- 3240
- group Id
- OG004
- lower Limit
- 130000
- upper Limit
- 130000
- value
- 130000
- group Id
- OG006
- lower Limit
- 20600
- upper Limit
- 84000
- value
- 52300
- group Id
- OG007
- lower Limit
- 110000
- upper Limit
- 345000
- value
- 128000
- group Id
- OG008
- lower Limit
- 111000
- upper Limit
- 191000
- value
- 118000
- group Id
- OG009
- lower Limit
- 84600
- upper Limit
- 267000
- value
- 176000
- group Id
- OG010
- lower Limit
- 31000
- upper Limit
- 74300
- value
- 52600
- group Id
- OG011
- lower Limit
- 48700
- upper Limit
- 91300
- value
- 51800
- group Id
- OG013
- lower Limit
- 0.00
- upper Limit
- 28300
- value
- 23600
- group Id
- OG014
- lower Limit
- 33900
- upper Limit
- 133000
- value
- 86800
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 2
- group Id
- OG011
- value
- 5
- units
- Participants
- title
- Cycle 1 day 8
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 2
- 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. AUC0-24 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 1 pre, EOI, 1, 2, 3, 5, and 7 hrs EOI, cycle 1 day 8 pre and EOI
- title
- Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) 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