TriangleNCT02675452 · OUTCOME
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
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
- Days 1 to 28 of cycle 1 (4 weeks)
What was measured
A DLT was assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v 4.0, and considered by the investigators to be related to AMG 176. A DLT was defined as a grade 3 or higher non-hematological or a grade 4 hematologic adverse event (AE) that occurred during the DLT observation period. CTCAE is graded from grade 1 to 5, with higher grades indicating a worse outcome, and included; grade 1 = mild, grade 2= moderate, grade 3 = severe, grade 4 = life-threatening, and grade 5 = death.
Analysis population: DLT-evaluable analysis set included participants if they experienced a DLT during the DLT evaluation period or if they received at least 75% of the planned doses of AMG 176 (and 100% of the planned doses of azacitidine in Part 4) and completed the DLT evaluation period.
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 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 | 4 |
| 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 | 3 |
| 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 | 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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Cohort 1 (MM): AMG 176 Dose A BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 2 (MM): AMG 176 Dose B BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 3 (MM): AMG 176 Dose C BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 4 (MM): AMG 176 Dose D BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 5 (MM): AMG 176 Dose E BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 6 (MM): AMG 176 Dose G BIW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 3 (MM): AMG 176 Dose E Then Dose H QW | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1B Cohort 4 (MM): AMG 176 Dose E Then Dose I QW | 0 | Not reported | Not reported | Not reported | Not reported |
| 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 |
Complete source fields
- classes
- categories
- measurements
- 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
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- 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
- 4
- 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
- A DLT was assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v 4.0, and considered by the investigators to be related to AMG 176. A DLT was defined as a grade 3 or higher non-hematological or a grade 4 hematologic adverse event (AE) that occurred during the DLT observation period. CTCAE is graded from grade 1 to 5, with higher grades indicating a worse outcome, and included; grade 1 = mild, grade 2= moderate, grade 3 = severe, grade 4 = life-threatening, and grade 5 = death.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- DLT-evaluable analysis set included participants if they experienced a DLT during the DLT evaluation period or if they received at least 75% of the planned doses of AMG 176 (and 100% of the planned doses of azacitidine in Part 4) and completed the DLT evaluation period.
- reporting Status
- POSTED
- time Frame
- Days 1 to 28 of cycle 1 (4 weeks)
- title
- Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice