TriangleNCT02675452 · OUTCOME
Maximum Observed Concentration (Cmax) of AMG 176
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- ng/mL
- Interval / dispersion
- Full Range
- Time frame
- Parts 1B, 3B, 3C, 3A (cohort 4) Cycle 1: day 1 pre, end of infusion (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 pharmacokinetic (PK) parameters. Concentrations below the lower limit of quantification (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 | 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 | 5 |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 5 |
| 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 | 2 |
| 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 | 5 |
| 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 | 3 |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 4 |
| 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 | 9 |
| 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 | 10 |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 13 |
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 | 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 | 2 |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 4 |
| 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 | 2 |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 2 |
| 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 | 5 |
| 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 | 3 |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 4 |
| 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 | 9 |
| 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 | 10 |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 13 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 2270 | Not reported | 1980 | 3690 | Not reported |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 2900 | Not reported | 1730 | 4340 | Not reported |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 3590 | Not reported | 1490 | 4310 | Not reported |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 5790 | Not reported | 4420 | 7160 | Not reported |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 10100 | Not reported | 9640 | 19000 | Not reported |
| Part 1A Cohort 6 (MM): AMG 176 Dose G BIW | 26100 | Not reported | 25500 | 26700 | Not reported |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 10100 | Not reported | 7490 | 14200 | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 24700 | Not reported | 3180 | 46200 | Not reported |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 4880 | Not reported | 3580 | 5920 | Not reported |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 5440 | Not reported | 3950 | 8590 | Not reported |
| Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW | 7940 | Not reported | 7010 | 9760 | Not reported |
| Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW | 6450 | Not reported | 6390 | 7460 | Not reported |
| Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW | 12100 | Not reported | 3080 | 21100 | Not reported |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 4590 | Not reported | 4130 | 5050 | Not reported |
| Part 3A Cohort 1 (AML): AMG 176 Dose D BIW | 5140 | Not reported | 3000 | 11900 | Not reported |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 5570 | Not reported | 3260 | 13800 | Not reported |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 6250 | Not reported | 4010 | 30800 | Not reported |
| Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW | 7790 | Not reported | 7400 | 8180 | Not reported |
| Part 3B Cohort 1 (AML): AMG 176 Dose E QW | 3600 | Not reported | 2850 | 5880 | Not reported |
| Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW | 5230 | Not reported | 3070 | 5360 | Not reported |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 3270 | Not reported | 0.00 | 5510 | Not reported |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 6290 | Not reported | 5900 | 7210 | Not reported |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 1670 | Not reported | 0.00 | 2400 | Not reported |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 5500 | Not reported | 0.00 | 21900 | Not reported |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 5380 | Not reported | 0.00 | 10700 | 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 | 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 | 1 |
| 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 | 5 |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 5 |
| 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 | 5 |
| 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 | 10 |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 11 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 1780 | Not reported | 1490 | 4080 | Not reported |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 3800 | Not reported | 2340 | 5420 | Not reported |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 3570 | Not reported | 1290 | 4910 | Not reported |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 8270 | Not reported | 7020 | 9520 | Not reported |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 11800 | Not reported | 11200 | 12900 | Not reported |
| Part 1A Cohort 6 (MM): AMG 176 Dose G BIW | 27300 | Not reported | 27300 | 27300 | Not reported |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 6500 | Not reported | 2890 | 8400 | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 7980 | Not reported | 6770 | 42600 | Not reported |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 5230 | Not reported | 0.00 | 16600 | Not reported |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 7670 | Not reported | 4590 | 32000 | Not reported |
| Part 3A Cohort 1 (AML): AMG 176 Dose D BIW | 6280 | Not reported | 2760 | 16100 | Not reported |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 7250 | Not reported | 4620 | 21600 | Not reported |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 6910 | Not reported | 4340 | 128000 | Not reported |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 4200 | Not reported | 0.00 | 23500 | Not reported |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 7050 | Not reported | 3440 | 143000 | Not reported |
Cycle 1 day 8
| 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 | 1 |
| 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 | 5 |
| 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 | 3 |
| 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 | 3 |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 4 |
| 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 | 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 | 9 |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 12 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 1740 | Not reported | 1140 | 2930 | Not reported |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 3830 | Not reported | 1660 | 4510 | Not reported |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 3250 | Not reported | 1590 | 4840 | Not reported |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 5650 | Not reported | 3910 | 6470 | Not reported |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 10200 | Not reported | 9740 | 11300 | Not reported |
| Part 1A Cohort 6 (MM): AMG 176 Dose G BIW | 39400 | Not reported | 39400 | 39400 | Not reported |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 17700 | Not reported | 10300 | 25000 | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 18400 | Not reported | 10600 | 80300 | Not reported |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 18700 | Not reported | 14700 | 22200 | Not reported |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 31900 | Not reported | 28500 | 35300 | Not reported |
| Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW | 16100 | Not reported | 10600 | 26700 | Not reported |
| Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW | 15000 | Not reported | 13800 | 17200 | Not reported |
| Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW | 23800 | Not reported | 23800 | 23800 | Not reported |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 37600 | Not reported | 26700 | 41900 | Not reported |
| Part 3A Cohort 1 (AML): AMG 176 Dose D BIW | 5580 | Not reported | 2660 | 12200 | Not reported |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 8500 | Not reported | 6570 | 27200 | Not reported |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 12700 | Not reported | 7140 | 187000 | Not reported |
| Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW | 12200 | Not reported | 11400 | 12900 | Not reported |
| Part 3B Cohort 1 (AML): AMG 176 Dose E QW | 3770 | Not reported | 2520 | 5420 | Not reported |
| Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW | 6300 | Not reported | 28.6 | 21300 | Not reported |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 11100 | Not reported | 0.00 | 15100 | Not reported |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 6020 | Not reported | 5730 | 8610 | Not reported |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 1850 | Not reported | 1230 | 18900 | Not reported |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 4710 | Not reported | 0.00 | 13500 | Not reported |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 12700 | Not reported | 0.00 | 311000 | Not reported |
Cycle 1 day 9
| 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 | 1 |
| 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 | 1 |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 5 |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 5 |
| 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 | 3 |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 4 |
| 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 | 4 |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 7 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 2810 | Not reported | 34.7 | 4070 | Not reported |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 3830 | Not reported | 2010 | 6780 | Not reported |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 4480 | Not reported | 824 | 7130 | Not reported |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 6400 | Not reported | 6010 | 7230 | Not reported |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 11400 | Not reported | 11000 | 14100 | Not reported |
| Part 1A Cohort 6 (MM): AMG 176 Dose G BIW | 27300 | Not reported | 27300 | 27300 | Not reported |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 15900 | Not reported | 13700 | 29400 | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 91100 | Not reported | 91100 | 91100 | Not reported |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 19800 | Not reported | 11900 | 22900 | Not reported |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 21100 | Not reported | 7030 | 21600 | Not reported |
| Part 3A Cohort 1 (AML): AMG 176 Dose D BIW | 9530 | Not reported | 2700 | 10800 | Not reported |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 8670 | Not reported | 6490 | 10800 | Not reported |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 12100 | Not reported | 7230 | 34900 | Not reported |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 6880 | Not reported | 1850 | 26700 | Not reported |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 14300 | Not reported | 40.1 | 52600 | 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 | 7 |
| 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 | 2140 | Not reported | 838 | 29300 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1980
- upper Limit
- 3690
- value
- 2270
- group Id
- OG001
- lower Limit
- 1730
- upper Limit
- 4340
- value
- 2900
- group Id
- OG002
- lower Limit
- 1490
- upper Limit
- 4310
- value
- 3590
- group Id
- OG003
- lower Limit
- 4420
- upper Limit
- 7160
- value
- 5790
- group Id
- OG004
- lower Limit
- 9640
- upper Limit
- 19000
- value
- 10100
- group Id
- OG005
- lower Limit
- 25500
- upper Limit
- 26700
- value
- 26100
- group Id
- OG006
- lower Limit
- 7490
- upper Limit
- 14200
- value
- 10100
- group Id
- OG007
- lower Limit
- 3180
- upper Limit
- 46200
- value
- 24700
- group Id
- OG008
- lower Limit
- 3580
- upper Limit
- 5920
- value
- 4880
- group Id
- OG009
- lower Limit
- 3950
- upper Limit
- 8590
- value
- 5440
- group Id
- OG010
- lower Limit
- 7010
- upper Limit
- 9760
- value
- 7940
- group Id
- OG011
- lower Limit
- 6390
- upper Limit
- 7460
- value
- 6450
- 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
- 2
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 3
- units
- Participants
- title
- Cycle 1 day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1490
- upper Limit
- 4080
- value
- 1780
- group Id
- OG001
- lower Limit
- 2340
- upper Limit
- 5420
- value
- 3800
- group Id
- OG002
- lower Limit
- 1290
- upper Limit
- 4910
- value
- 3570
- group Id
- OG003
- lower Limit
- 7020
- upper Limit
- 9520
- value
- 8270
- group Id
- OG004
- lower Limit
- 11200
- upper Limit
- 12900
- value
- 11800
- group Id
- OG005
- lower Limit
- 27300
- upper Limit
- 27300
- value
- 27300
- group Id
- OG006
- lower Limit
- 2890
- upper Limit
- 8400
- value
- 6500
- group Id
- OG007
- lower Limit
- 6770
- upper Limit
- 42600
- value
- 7980
- group Id
- OG008
- lower Limit
- 0.00
- upper Limit
- 16600
- value
- 5230
- group Id
- OG009
- lower Limit
- 4590
- upper Limit
- 32000
- value
- 7670
- group Id
- OG014
- lower Limit
- 2760
- upper Limit
- 16100
- value
- 6280
- group Id
- OG015
- lower Limit
- 4620
- upper Limit
- 21600
- value
- 7250
- 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
- 1
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 5
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- Cycle 1 day 2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1140
- upper Limit
- 2930
- value
- 1740
- group Id
- OG001
- lower Limit
- 1660
- upper Limit
- 4510
- value
- 3830
- group Id
- OG002
- lower Limit
- 1590
- upper Limit
- 4840
- value
- 3250
- group Id
- OG003
- lower Limit
- 3910
- upper Limit
- 6470
- value
- 5650
- group Id
- OG004
- lower Limit
- 9740
- upper Limit
- 11300
- value
- 10200
- group Id
- OG005
- lower Limit
- 39400
- upper Limit
- 39400
- value
- 39400
- group Id
- OG006
- lower Limit
- 10300
- upper Limit
- 25000
- value
- 17700
- group Id
- OG007
- lower Limit
- 10600
- upper Limit
- 80300
- value
- 18400
- group Id
- OG008
- lower Limit
- 14700
- upper Limit
- 22200
- value
- 18700
- group Id
- OG009
- lower Limit
- 28500
- upper Limit
- 35300
- value
- 31900
- group Id
- OG010
- lower Limit
- 10600
- upper Limit
- 26700
- value
- 16100
- group Id
- OG011
- lower Limit
- 13800
- upper Limit
- 17200
- value
- 15000
- 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
- 1
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 3
- units
- Participants
- title
- Cycle 1 day 8
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.7
- upper Limit
- 4070
- value
- 2810
- group Id
- OG001
- lower Limit
- 2010
- upper Limit
- 6780
- value
- 3830
- group Id
- OG002
- lower Limit
- 824
- upper Limit
- 7130
- value
- 4480
- group Id
- OG003
- lower Limit
- 6010
- upper Limit
- 7230
- value
- 6400
- group Id
- OG004
- lower Limit
- 11000
- upper Limit
- 14100
- value
- 11400
- group Id
- OG005
- lower Limit
- 27300
- upper Limit
- 27300
- value
- 27300
- group Id
- OG006
- lower Limit
- 13700
- upper Limit
- 29400
- value
- 15900
- group Id
- OG007
- lower Limit
- 91100
- upper Limit
- 91100
- value
- 91100
- group Id
- OG008
- lower Limit
- 11900
- upper Limit
- 22900
- value
- 19800
- group Id
- OG009
- lower Limit
- 7030
- upper Limit
- 21600
- value
- 21100
- group Id
- OG014
- lower Limit
- 2700
- upper Limit
- 10800
- value
- 9530
- group Id
- OG015
- lower Limit
- 6490
- upper Limit
- 10800
- value
- 8670
- 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
- 1
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 5
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- Cycle 1 day 9
- categories
- measurements
- group Id
- OG022
- lower Limit
- 838
- upper Limit
- 29300
- value
- 2140
- 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
- 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
- 5
- group Id
- OG009
- value
- 5
- 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 pharmacokinetic (PK) parameters. Concentrations below the lower limit of quantification (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, end of infusion (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
- Maximum Observed Concentration (Cmax) of AMG 176
- type
- PRIMARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice