TriangleNCT02675452 · OUTCOME
Best Overall Response According to the 2017 European LeukemiaNet (ELN) Criteria in AML Participants (Parts 3A, 3B, 3C, 3D, and 4)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Day 1 cycle 1 to end of study; median duration from start of study treatment to end of study for all participants was 2.2 months
What was measured
A response was of any of the following, per the ELN criteria: Complete remission (CR) without minimal residual disease (CRMRD-), CR, CR with incomplete hematology recovery (CRi), morphologic leukemia-free state (MLFS), partial remission (PR), SD, PD. CRMRD-: CR with negativity for genetic marker by quantitative reverse transcription (RT-qPCR) or multicolor flow cytometry (MFC); CR: BM blasts \<5% bone marrow, no circulating blasts/ extramedullary disease, ANC \> 1.0 x 10\^9/L, platelets ≥ 100 x 10\^9/L; CRi: CR except for neutropenia (\< 1.0 x 10\^9/L) or thrombocytopenia (\< 100 x 10\^9/L); MLFS: BM blasts \< 5% no blasts with auer rods/extramedullary disease, no hematologic recovery; PR: hematological criteria of CR; decrease BM blast to 5-25%; decrease of BM blast percentage by ≤ 50%; SD: absence of CRMRD-, CR, CRi, PR, MLFS and criteria for PD not met; PD: evidence of increase in BM blast percentage and/or increase of absolute blast count.
Analysis population: The FAS included all participants who received at least 1 dose of AMG 176.
Groups in this outcome
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 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 | 10 |
| Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine | 5 |
| Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine | 4 |
| Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine | 4 |
| Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine | 13 |
| 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
CRMRD-
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 3A Cohort 1 (AML): AMG 176 Dose D BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 1 (AML): AMG 176 Dose E QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 1 | Not reported | Not reported | Not reported | Not reported |
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 3A Cohort 1 (AML): AMG 176 Dose D BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 1 (AML): AMG 176 Dose E QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
CRi
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 3A Cohort 1 (AML): AMG 176 Dose D BIW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 1 (AML): AMG 176 Dose E QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
MLFS
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 3A Cohort 1 (AML): AMG 176 Dose D BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 1 (AML): AMG 176 Dose E QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 3A Cohort 1 (AML): AMG 176 Dose D BIW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 1 (AML): AMG 176 Dose E QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 3A Cohort 1 (AML): AMG 176 Dose D BIW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 1 (AML): AMG 176 Dose E QW | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 7 | Not reported | Not reported | Not reported | Not reported |
PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 3A Cohort 1 (AML): AMG 176 Dose D BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 1 (AML): AMG 176 Dose E QW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
No post-baseline response evaluation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 3A Cohort 1 (AML): AMG 176 Dose D BIW | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 2 (AML): AMG 176 Dose E BIW | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 1 (AML): AMG 176 Dose E QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole | 7 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 4 (AML): AMG 176 Dose E Then Dose G QW + Azacitidine | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 5A (AML): AMG 176 Dose E BIW + Azacitidine | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 4 Cohort 5B (AML): AMG 176 Dose E the Dose G BIW + Azacitidine | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
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- 1
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- title
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- group Id
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- 1
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- value
- 0
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- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 3
- title
- SD
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- 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
- 1
- title
- PD
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 7
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- No post-baseline response evaluation
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 10
- group Id
- OG009
- value
- 5
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 4
- units
- Participants
- description
- A response was of any of the following, per the ELN criteria: Complete remission (CR) without minimal residual disease (CRMRD-), CR, CR with incomplete hematology recovery (CRi), morphologic leukemia-free state (MLFS), partial remission (PR), SD, PD. CRMRD-: CR with negativity for genetic marker by quantitative reverse transcription (RT-qPCR) or multicolor flow cytometry (MFC); CR: BM blasts \<5% bone marrow, no circulating blasts/ extramedullary disease, ANC \> 1.0 x 10\^9/L, platelets ≥ 100 x 10\^9/L; CRi: CR except for neutropenia (\< 1.0 x 10\^9/L) or thrombocytopenia (\< 100 x 10\^9/L); MLFS: BM blasts \< 5% no blasts with auer rods/extramedullary disease, no hematologic recovery; PR: hematological criteria of CR; decrease BM blast to 5-25%; decrease of BM blast percentage by ≤ 50%; SD: absence of CRMRD-, CR, CRi, PR, MLFS and criteria for PD not met; PD: evidence of increase in BM blast percentage and/or increase of absolute blast count.
- groups
- description
- Participants with AML received AMG 176 Dose D BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG000
- title
- Part 3A Cohort 1 (AML): AMG 176 Dose D BIW
- description
- Participants with AML received AMG 176 Dose E BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG001
- title
- Part 3A Cohort 2 (AML): AMG 176 Dose E BIW
- description
- 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.
- id
- OG002
- title
- Part 3A Cohort 3 (AML): AMG 176 Dose E Then Dose F BIW
- description
- 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.
- id
- OG003
- title
- Part 3A Cohort 4 (Japanese Participants With AML): AMG 176 Dose E Then Dose F QW
- description
- Participants with AML received AMG 176 Dose E QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG004
- title
- Part 3B Cohort 1 (AML): AMG 176 Dose E QW
- description
- 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.
- id
- OG005
- title
- Part 3B Cohort 2 (AML): AMG 176 Dose E Then Dose F QW
- description
- 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.
- id
- OG006
- title
- Part 3B Cohort 3 (AML): AMG 176 Dose E Then Dose G QW
- description
- Japanese participants with AML received AMG 176 Dose E QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
- id
- OG007
- title
- Part 3C Cohort 1 (Japanese Participants With AML): AMG 176 Dose E QW
- description
- 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.
- id
- OG008
- title
- Part 3D Cohort 1 (AML): AMG 176 Dose D QW + Itraconazole
- description
- 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.
- id
- OG009
- title
- Part 4 Cohort 1 (AML): AMG 176 Dose D QW + Azacitidine
- description
- 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.
- id
- OG010
- title
- Part 4 Cohort 2 (AML): AMG 176 Dose E QW + Azacitidine
- description
- 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.
- id
- OG011
- title
- Part 4 Cohort 3 (AML): AMG 176 Dose E Then Dose F QW + Azacitidine
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The FAS included all participants who received at least 1 dose of AMG 176.
- reporting Status
- POSTED
- time Frame
- Day 1 cycle 1 to end of study; median duration from start of study treatment to end of study for all participants was 2.2 months
- title
- Best Overall Response According to the 2017 European LeukemiaNet (ELN) Criteria in AML Participants (Parts 3A, 3B, 3C, 3D, and 4)
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice