TriangleNCT03465540 · OUTCOME
Maximum Observed Concentration (Cmax) of AMG 397
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- µg/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1 (cycle = 28 days): Predose, 1, 2, 3, 5, 8 & 12 hours postdose on Day 1; predose, 1, 2, 3, 5, 8, 12, 24 & 48 hours postdose on Day 2
What was measured
Predose data for Day 2 were analyzed/included with the Day 1 data.
Analysis population: The Pharmacokinetic (PK) Analysis Set: All participants who received at least 1 dose of AMG 397 and had at least 1 PK sample collected.
Groups in this outcome
Part 1a: 80 mg AMG 397
Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Part 1a: 160 mg AMG 397
Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Part 1a: 320 mg AMG 397
Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Part 1b: 80 mg AMG 397
Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Part 1b: 160 mg AMG 397
Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Part 1b: 320 mg AMG 397
Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
| Group | Source count |
|---|---|
| Part 1a: 80 mg AMG 397 | 2 |
| Part 1a: 160 mg AMG 397 | 6 |
| Part 1a: 320 mg AMG 397 | 4 |
| Part 1b: 80 mg AMG 397 | 4 |
| Part 1b: 160 mg AMG 397 | 5 |
| Part 1b: 320 mg AMG 397 | 3 |
Reported measurements
Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1a: 80 mg AMG 397 | 0.415 | 0.470 | 0.470 | 09.999 | Not reported |
| Part 1a: 160 mg AMG 397 | 0.468 | 0.606 | 0.606 | Not reported | Not reported |
| Part 1a: 320 mg AMG 397 | 0.908 | 1.19 | 1.19 | Not reported | Not reported |
| Part 1b: 80 mg AMG 397 | 0.747 | 0.785 | 0.785 | Not reported | Not reported |
| Part 1b: 160 mg AMG 397 | 1.31 | 1.87 | 1.87 | Not reported | Not reported |
| Part 1b: 320 mg AMG 397 | 2.51 | 2.83 | 2.83 | Not reported | Not reported |
Day 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1a: 80 mg AMG 397 | 1.17 | 1.29 | 1.29 | Not reported | Not reported |
| Part 1a: 160 mg AMG 397 | 1.80 | 1.88 | 1.88 | Not reported | Not reported |
| Part 1a: 320 mg AMG 397 | 2.822 | 3.17 | 3.17 | Not reported | Not reported |
| Part 1b: 80 mg AMG 397 | 1.41 | 1.51 | 1.51 | Not reported | Not reported |
| Part 1b: 160 mg AMG 397 | 3.69 | 4.46 | 4.46 | Not reported | Not reported |
| Part 1b: 320 mg AMG 397 | 4.57 | 5.14 | 5.14 | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.470
- spread
- 0.470
- upper Limit
- 09.999
- value
- 0.415
- group Id
- OG001
- lower Limit
- 0.606
- spread
- 0.606
- value
- 0.468
- group Id
- OG002
- lower Limit
- 1.19
- spread
- 1.19
- value
- 0.908
- group Id
- OG003
- lower Limit
- 0.785
- spread
- 0.785
- value
- 0.747
- group Id
- OG004
- lower Limit
- 1.87
- spread
- 1.87
- value
- 1.31
- group Id
- OG005
- lower Limit
- 2.83
- spread
- 2.83
- value
- 2.51
- title
- Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.29
- spread
- 1.29
- value
- 1.17
- group Id
- OG001
- lower Limit
- 1.88
- spread
- 1.88
- value
- 1.80
- group Id
- OG002
- lower Limit
- 3.17
- spread
- 3.17
- value
- 2.822
- group Id
- OG003
- lower Limit
- 1.51
- spread
- 1.51
- value
- 1.41
- group Id
- OG004
- lower Limit
- 4.46
- spread
- 4.46
- value
- 3.69
- group Id
- OG005
- lower Limit
- 5.14
- spread
- 5.14
- value
- 4.57
- title
- Day 2
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 3
- units
- Participants
- description
- Predose data for Day 2 were analyzed/included with the Day 1 data.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
- id
- OG000
- title
- Part 1a: 80 mg AMG 397
- description
- Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
- id
- OG001
- title
- Part 1a: 160 mg AMG 397
- description
- Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
- id
- OG002
- title
- Part 1a: 320 mg AMG 397
- description
- Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
- id
- OG003
- title
- Part 1b: 80 mg AMG 397
- description
- Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
- id
- OG004
- title
- Part 1b: 160 mg AMG 397
- description
- Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
- id
- OG005
- title
- Part 1b: 320 mg AMG 397
- param Type
- GEOMETRIC_MEAN
- population Description
- The Pharmacokinetic (PK) Analysis Set: All participants who received at least 1 dose of AMG 397 and had at least 1 PK sample collected.
- reporting Status
- POSTED
- time Frame
- Cycle 1 (cycle = 28 days): Predose, 1, 2, 3, 5, 8 & 12 hours postdose on Day 1; predose, 1, 2, 3, 5, 8, 12, 24 & 48 hours postdose on Day 2
- title
- Maximum Observed Concentration (Cmax) of AMG 397
- type
- SECONDARY
- unit Of Measure
- µg/mL
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Preserved source evidence · Not medical advice