TriangleNCT02675452 · OUTCOME
Terminal Half-life (t1/2) of AMG 176
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hours
- 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.
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 | 1 |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 1 |
| 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 | 3 |
| 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 | 1 |
| 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 | 0 |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 1 |
| Part 3A Cohort 1 (AML): AMG 176 Dose D BIW | 5 |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 4 |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 4 |
| 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 | 1 |
| 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 | 2 |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 1 |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 5 |
| 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 | 2 |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 5 |
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 | 1 |
| 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 | 1 |
| 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 | 1 |
| 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 | 1 |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 1 |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 5 |
| 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 | 19.6 | Not reported | 19.6 | 19.6 | Not reported |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 2.58 | Not reported | 2.58 | 2.58 | Not reported |
| Part 3B Cohort 1 (AML): AMG 176 Dose E QW | 2.62 | Not reported | 2.62 | 2.62 | Not reported |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 47.3 | Not reported | 47.3 | 47.3 | Not reported |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 17.4 | Not reported | 17.4 | 17.4 | Not reported |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 4.42 | Not reported | 2.91 | 10.2 | 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 | 1 |
| 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 | 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 | 5 |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 4 |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 4 |
| 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 | 2 |
| 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 | 3.33 | Not reported | 2.46 | 8.20 | Not reported |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 9.18 | Not reported | 6.93 | 9.55 | Not reported |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 7.66 | Not reported | 3.14 | 10.7 | Not reported |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 7.98 | Not reported | 7.34 | 8.61 | Not reported |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 7.43 | Not reported | 6.31 | 10.4 | Not reported |
| Part 1A Cohort 6 (MM): AMG 176 Dose G BIW | 11.3 | Not reported | 11.3 | 11.3 | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 18.5 | Not reported | 18.5 | 18.5 | Not reported |
| Part 3A Cohort 1 (AML): AMG 176 Dose D BIW | 15.3 | Not reported | 3.63 | 58.9 | Not reported |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 20.6 | Not reported | 5.69 | 33.6 | Not reported |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 6.85 | Not reported | 5.04 | 19.3 | Not reported |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 17.7 | Not reported | 5.78 | 29.6 | Not reported |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 9.98 | Not reported | 7.44 | 24.3 | 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 | 0 |
| 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 | 0 |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 1 |
| 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 | 1 |
| 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 | 2 |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 1 |
| 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 | 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 2 (MM): AMG 176 Dose E Then Dose G QW | 46.7 | Not reported | 25.6 | 67.7 | Not reported |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 28.3 | Not reported | 28.3 | 28.3 | Not reported |
| Part 3B Cohort 1 (AML): AMG 176 Dose E QW | 3.70 | Not reported | 3.70 | 3.70 | Not reported |
| Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW | 35.6 | Not reported | 30.8 | 40.4 | Not reported |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 11.7 | Not reported | 5.44 | 18.1 | Not reported |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 17.8 | Not reported | 17.8 | 17.8 | Not reported |
Cycle 1 day 9
| 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 | 1 |
| 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 | 3 |
| 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 | 1 |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 3 |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 2 |
| 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 | 2 |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 1.05 | Not reported | 1.05 | 1.05 | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 44.5 | Not reported | 44.5 | 44.5 | Not reported |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 12.9 | Not reported | 10.9 | 14.6 | Not reported |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 16.9 | Not reported | 12.6 | 20.5 | Not reported |
| Part 3A Cohort 1 (AML): AMG 176 Dose D BIW | 34.0 | Not reported | 34.0 | 34.0 | Not reported |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 24.6 | Not reported | 21.9 | 42.0 | Not reported |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 9.81 | Not reported | 8.17 | 11.5 | Not reported |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 4.33 | Not reported | 4.08 | 4.59 | Not reported |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 15.4 | Not reported | 7.06 | 17.3 | 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 | 1 |
| 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 | 9.08 | Not reported | 9.08 | 9.08 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG010
- lower Limit
- 19.6
- upper Limit
- 19.6
- value
- 19.6
- group Id
- OG013
- lower Limit
- 2.58
- upper Limit
- 2.58
- value
- 2.58
- group Id
- OG018
- lower Limit
- 2.62
- upper Limit
- 2.62
- value
- 2.62
- group Id
- OG020
- lower Limit
- 47.3
- upper Limit
- 47.3
- value
- 47.3
- group Id
- OG021
- lower Limit
- 17.4
- upper Limit
- 17.4
- value
- 17.4
- group Id
- OG022
- lower Limit
- 2.91
- upper Limit
- 10.2
- value
- 4.42
- 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
- 1
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- Cycle 1 day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.46
- upper Limit
- 8.20
- value
- 3.33
- group Id
- OG001
- lower Limit
- 6.93
- upper Limit
- 9.55
- value
- 9.18
- group Id
- OG002
- lower Limit
- 3.14
- upper Limit
- 10.7
- value
- 7.66
- group Id
- OG003
- lower Limit
- 7.34
- upper Limit
- 8.61
- value
- 7.98
- group Id
- OG004
- lower Limit
- 6.31
- upper Limit
- 10.4
- value
- 7.43
- group Id
- OG005
- lower Limit
- 11.3
- upper Limit
- 11.3
- value
- 11.3
- group Id
- OG007
- lower Limit
- 18.5
- upper Limit
- 18.5
- value
- 18.5
- group Id
- OG014
- lower Limit
- 3.63
- upper Limit
- 58.9
- value
- 15.3
- group Id
- OG015
- lower Limit
- 5.69
- upper Limit
- 33.6
- value
- 20.6
- group Id
- OG016
- lower Limit
- 5.04
- upper Limit
- 19.3
- value
- 6.85
- group Id
- OG027
- lower Limit
- 5.78
- upper Limit
- 29.6
- value
- 17.7
- group Id
- OG028
- lower Limit
- 7.44
- upper Limit
- 24.3
- value
- 9.98
- 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
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- 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 2
- categories
- measurements
- group Id
- OG011
- lower Limit
- 25.6
- upper Limit
- 67.7
- value
- 46.7
- group Id
- OG013
- lower Limit
- 28.3
- upper Limit
- 28.3
- value
- 28.3
- group Id
- OG018
- lower Limit
- 3.70
- upper Limit
- 3.70
- value
- 3.70
- group Id
- OG019
- lower Limit
- 30.8
- upper Limit
- 40.4
- value
- 35.6
- group Id
- OG020
- lower Limit
- 5.44
- upper Limit
- 18.1
- value
- 11.7
- group Id
- OG021
- lower Limit
- 17.8
- upper Limit
- 17.8
- value
- 17.8
- 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
- 2
- units
- Participants
- title
- Cycle 1 day 8
- categories
- measurements
- group Id
- OG006
- lower Limit
- 1.05
- upper Limit
- 1.05
- value
- 1.05
- group Id
- OG007
- lower Limit
- 44.5
- upper Limit
- 44.5
- value
- 44.5
- group Id
- OG008
- lower Limit
- 10.9
- upper Limit
- 14.6
- value
- 12.9
- group Id
- OG009
- lower Limit
- 12.6
- upper Limit
- 20.5
- value
- 16.9
- group Id
- OG014
- lower Limit
- 34.0
- upper Limit
- 34.0
- value
- 34.0
- group Id
- OG015
- lower Limit
- 21.9
- upper Limit
- 42.0
- value
- 24.6
- group Id
- OG016
- lower Limit
- 8.17
- upper Limit
- 11.5
- value
- 9.81
- group Id
- OG027
- lower Limit
- 4.08
- upper Limit
- 4.59
- value
- 4.33
- group Id
- OG028
- lower Limit
- 7.06
- upper Limit
- 17.3
- value
- 15.4
- 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
- 1
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 3
- 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
- 9.08
- upper Limit
- 9.08
- value
- 9.08
- 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
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 2
- 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 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
- Terminal Half-life (t1/2) of AMG 176
- type
- PRIMARY
- unit Of Measure
- hours
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Preserved source evidence · Not medical advice