TriangleNCT02675452 · OUTCOME
Clearance (CL) of AMG 176
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- mL/hr/m^2
- Interval / dispersion
- Full Range
- Time frame
- Parts 1B, 3B, 3C, 3A (cohort 4) Cycle 1: day 1 pre, EOI, 1, 2, 3, 5, 7 hrs EOI, day 8 pre, EOI; Part 3D also days 9, 15 pre and EOI; Parts 1A, 3 (except cohort 4), 4: also day 2 pre, EOI, 1, 2, 3, 5, 7 hrs EOI, 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. Clearance was calculated as Dose/ AUC0-144 for Parts 1A, 3A, and 4; and as Dose/AUC0-168 for Parts 1B, 3 (Cohort 4 only) 3B, 3C, and 3D.
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. 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 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 3A 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 3A 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 3A 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 3A 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.
Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine
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 75 mg/m\^2 azacitidine SC or IV QD for 7 days in week 1.
Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine
Participants with AML received AMG 176 Dose E QW. 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 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine
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. They also received 75 mg/m\^2 azacitidine SC or IV QD for 7 days in week 1.
Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine
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. They also received 75 mg/m\^2 azacitidine SC or IV QD for 7 days in week 1.
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 | 3 |
| 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 3A Cohort 1 (AML): AMG 176 Dose D BIW | 5 |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 5 |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 3 |
| Part 3A 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 |
| Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine | 0 |
| Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine | 0 |
| Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine | 0 |
| Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine | 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 | 6 |
Reported measurements
Cycle 1 day 1
| 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 | 0 |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 0 |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 0 |
| 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 | 0 |
| 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 | 0 |
| 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 3A Cohort 1 (AML): AMG 176 Dose D BIW | 0 |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 0 |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 0 |
| Part 3A 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 |
| Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine | 0 |
| Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine | 0 |
| Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine | 0 |
| Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine | 0 |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 0 |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW | 0.886 | Not reported | 0.354 | 1.59 | Not reported |
| Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW | 0.819 | Not reported | 0.670 | 0.968 | Not reported |
| Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW | 1.17 | Not reported | 1.17 | 1.17 | Not reported |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 1.16 | Not reported | 1.07 | 1.24 | Not reported |
| Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW | 0.603 | Not reported | 0.556 | 0.650 | Not reported |
| Part 3B Cohort 1 (AML): AMG 176 Dose E QW | 1.47 | Not reported | 0.674 | 1.60 | Not reported |
| Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW | 1.88 | Not reported | 1.23 | 2.54 | Not reported |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 1.42 | Not reported | 1.14 | 2.82 | Not reported |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 0.605 | Not reported | 0.389 | 0.838 | Not reported |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 4.68 | Not reported | 2.74 | 6.18 | Not reported |
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 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 3A Cohort 1 (AML): AMG 176 Dose D BIW | 5 |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 5 |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 3 |
| Part 3A 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 | 0 |
| Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine | 0 |
| Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine | 0 |
| Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine | 0 |
| Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine | 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 | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 2.77 | Not reported | 1.50 | 3.66 | Not reported |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 1.58 | Not reported | 1.30 | 1.80 | Not reported |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 1.95 | Not reported | 1.36 | 9.00 | Not reported |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 1.07 | Not reported | 0.834 | 1.31 | Not reported |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 1.36 | Not reported | 1.04 | 1.50 | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 0.430 | Not reported | 0.430 | 0.430 | Not reported |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 0.309 | Not reported | 0.309 | 0.309 | Not reported |
| Part 3A Cohort 1 (AML): AMG 176 Dose D BIW | 1.73 | Not reported | 0.810 | 4.94 | Not reported |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 1.50 | Not reported | 0.698 | 2.28 | Not reported |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 0.981 | Not reported | 0.461 | 2.28 | Not reported |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 0.992 | Not reported | 0.992 | 0.992 | Not reported |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 1.20 | Not reported | 0.236 | 1.68 | 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 | 0 |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 0 |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 0 |
| 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 | 0 |
| 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 | 0 |
| 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 3A Cohort 1 (AML): AMG 176 Dose D BIW | 0 |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 0 |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 0 |
| Part 3A 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 |
| Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine | 0 |
| Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine | 0 |
| Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine | 0 |
| Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine | 0 |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 0 |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW | 0.992 | Not reported | 0.664 | 1.31 | Not reported |
| Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW | 0.686 | Not reported | 0.653 | 0.785 | Not reported |
| Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW | 1.10 | Not reported | 1.10 | 1.10 | Not reported |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 1.16 | Not reported | 0.357 | 2.57 | Not reported |
| Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW | 0.652 | Not reported | 0.476 | 0.828 | Not reported |
| Part 3B Cohort 1 (AML): AMG 176 Dose E QW | 3.58 | Not reported | 1.96 | 5.61 | Not reported |
| Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW | 0.407 | Not reported | 0.391 | 0.422 | Not reported |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 0.854 | Not reported | 0.396 | 1.01 | Not reported |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 0.782 | Not reported | 0.477 | 1.78 | Not reported |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 2.26 | Not reported | 2.10 | 3.62 | 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 | 3 |
| 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 3A Cohort 1 (AML): AMG 176 Dose D BIW | 2 |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 4 |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 0 |
| Part 3A 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 | 0 |
| Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine | 0 |
| Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine | 0 |
| Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine | 0 |
| Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine | 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 | 0.0556 | Not reported | 0.0556 | 0.0556 | Not reported |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 0.307 | Not reported | 0.185 | 0.335 | Not reported |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 0.218 | Not reported | 0.214 | 0.222 | Not reported |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 0.291 | Not reported | 0.291 | 0.291 | Not reported |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 0.278 | Not reported | 0.243 | 0.314 | Not reported |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 4.82 | Not reported | 0.712 | 8.93 | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 0.242 | Not reported | 0.242 | 0.242 | Not reported |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 0.756 | Not reported | 0.513 | 1.000 | Not reported |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 1.14 | Not reported | 0.560 | 1.65 | Not reported |
| Part 3A Cohort 1 (AML): AMG 176 Dose D BIW | 0.544 | Not reported | 0.0733 | 1.01 | Not reported |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 0.744 | Not reported | 0.393 | 1.24 | Not reported |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 0.978 | Not reported | 0.978 | 0.978 | Not reported |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 1.11 | Not reported | 0.856 | 1.36 | Not reported |
Cycle 1 day 15
| 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 | 0 |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 0 |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 0 |
| 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 | 0 |
| 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 | 0 |
| 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 3A Cohort 1 (AML): AMG 176 Dose D BIW | 0 |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 0 |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 0 |
| Part 3A 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 |
| Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine | 0 |
| Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine | 0 |
| Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine | 0 |
| Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine | 0 |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 0 |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 4.08 | Not reported | 0.640 | 15.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG010
- lower Limit
- 0.354
- upper Limit
- 1.59
- value
- 0.886
- group Id
- OG011
- lower Limit
- 0.670
- upper Limit
- 0.968
- value
- 0.819
- group Id
- OG012
- lower Limit
- 1.17
- upper Limit
- 1.17
- value
- 1.17
- group Id
- OG013
- lower Limit
- 1.07
- upper Limit
- 1.24
- value
- 1.16
- group Id
- OG017
- lower Limit
- 0.556
- upper Limit
- 0.650
- value
- 0.603
- group Id
- OG018
- lower Limit
- 0.674
- upper Limit
- 1.60
- value
- 1.47
- group Id
- OG019
- lower Limit
- 1.23
- upper Limit
- 2.54
- value
- 1.88
- group Id
- OG020
- lower Limit
- 1.14
- upper Limit
- 2.82
- value
- 1.42
- group Id
- OG021
- lower Limit
- 0.389
- upper Limit
- 0.838
- value
- 0.605
- group Id
- OG022
- lower Limit
- 2.74
- upper Limit
- 6.18
- value
- 4.68
- 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
- 0
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 2
- units
- Participants
- title
- Cycle 1 day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.50
- upper Limit
- 3.66
- value
- 2.77
- group Id
- OG001
- lower Limit
- 1.30
- upper Limit
- 1.80
- value
- 1.58
- group Id
- OG002
- lower Limit
- 1.36
- upper Limit
- 9.00
- value
- 1.95
- group Id
- OG003
- lower Limit
- 0.834
- upper Limit
- 1.31
- value
- 1.07
- group Id
- OG004
- lower Limit
- 1.04
- upper Limit
- 1.50
- value
- 1.36
- group Id
- OG007
- lower Limit
- 0.430
- upper Limit
- 0.430
- value
- 0.430
- group Id
- OG009
- lower Limit
- 0.309
- upper Limit
- 0.309
- value
- 0.309
- group Id
- OG014
- lower Limit
- 0.810
- upper Limit
- 4.94
- value
- 1.73
- group Id
- OG015
- lower Limit
- 0.698
- upper Limit
- 2.28
- value
- 1.50
- group Id
- OG016
- lower Limit
- 0.461
- upper Limit
- 2.28
- value
- 0.981
- group Id
- OG027
- lower Limit
- 0.992
- upper Limit
- 0.992
- value
- 0.992
- group Id
- OG028
- lower Limit
- 0.236
- upper Limit
- 1.68
- value
- 1.20
- 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
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- Cycle 1 day 2
- categories
- measurements
- group Id
- OG010
- lower Limit
- 0.664
- upper Limit
- 1.31
- value
- 0.992
- group Id
- OG011
- lower Limit
- 0.653
- upper Limit
- 0.785
- value
- 0.686
- group Id
- OG012
- lower Limit
- 1.10
- upper Limit
- 1.10
- value
- 1.10
- group Id
- OG013
- lower Limit
- 0.357
- upper Limit
- 2.57
- value
- 1.16
- group Id
- OG017
- lower Limit
- 0.476
- upper Limit
- 0.828
- value
- 0.652
- group Id
- OG018
- lower Limit
- 1.96
- upper Limit
- 5.61
- value
- 3.58
- group Id
- OG019
- lower Limit
- 0.391
- upper Limit
- 0.422
- value
- 0.407
- group Id
- OG020
- lower Limit
- 0.396
- upper Limit
- 1.01
- value
- 0.854
- group Id
- OG021
- lower Limit
- 0.477
- upper Limit
- 1.78
- value
- 0.782
- group Id
- OG022
- lower Limit
- 2.10
- upper Limit
- 3.62
- value
- 2.26
- 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
- 0
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 3
- units
- Participants
- title
- Cycle 1 day 8
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0556
- upper Limit
- 0.0556
- value
- 0.0556
- group Id
- OG001
- lower Limit
- 0.185
- upper Limit
- 0.335
- value
- 0.307
- group Id
- OG002
- lower Limit
- 0.214
- upper Limit
- 0.222
- value
- 0.218
- group Id
- OG003
- lower Limit
- 0.291
- upper Limit
- 0.291
- value
- 0.291
- group Id
- OG004
- lower Limit
- 0.243
- upper Limit
- 0.314
- value
- 0.278
- group Id
- OG006
- lower Limit
- 0.712
- upper Limit
- 8.93
- value
- 4.82
- group Id
- OG007
- lower Limit
- 0.242
- upper Limit
- 0.242
- value
- 0.242
- group Id
- OG008
- lower Limit
- 0.513
- upper Limit
- 1.000
- value
- 0.756
- group Id
- OG009
- lower Limit
- 0.560
- upper Limit
- 1.65
- value
- 1.14
- group Id
- OG014
- lower Limit
- 0.0733
- upper Limit
- 1.01
- value
- 0.544
- group Id
- OG015
- lower Limit
- 0.393
- upper Limit
- 1.24
- value
- 0.744
- group Id
- OG027
- lower Limit
- 0.978
- upper Limit
- 0.978
- value
- 0.978
- 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
- 3
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- Cycle 1 day 9
- categories
- measurements
- group Id
- OG022
- lower Limit
- 0.640
- upper Limit
- 15.9
- value
- 4.08
- 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
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- Cycle 1 day 15
- 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
- 3
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 3
- 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. Clearance was calculated as Dose/ AUC0-144 for Parts 1A, 3A, and 4; and as Dose/AUC0-168 for Parts 1B, 3 (Cohort 4 only) 3B, 3C, and 3D.
- 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 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
- OG010
- 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
- OG011
- title
- Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW
- 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. Participants with data available at each time point are presented.
- reporting Status
- POSTED
- time Frame
- Parts 1B, 3B, 3C, 3A (cohort 4) Cycle 1: day 1 pre, EOI, 1, 2, 3, 5, 7 hrs EOI, day 8 pre, EOI; Part 3D also days 9, 15 pre and EOI; Parts 1A, 3 (except cohort 4), 4: also day 2 pre, EOI, 1, 2, 3, 5, 7 hrs EOI, day 9 pre and EOI
- title
- Clearance (CL) of AMG 176
- type
- PRIMARY
- unit Of Measure
- mL/hr/m^2
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Preserved source evidence · Not medical advice