TriangleNCT03465540 · OUTCOME
Overall Response Rate (ORR) for Participants With Acute Myeloid Leukemia (AML)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to end of study (a maximum of 48 weeks)
What was measured
ORR was assessed for participants with AML using response criteria per European Leukemia Network Response Criteria. ORR was defined as the percentage of participants who experienced either of the following based on investigator assessment: * PR * morphological leukemia-free state (MLFS) * complete remission with incomplete hematologic recovery (CRi) * complete remission * complete remission without minimal residual disease (CRmrd-).
Analysis population: Parts 2 and 3 were not initiated and did not enrol any participants, therefore results presented only included participants in part 1. Participants with AML were only enrolled in part 1b, so therefore data is only presented for part 1b. FAS: All participants who were enrolled and received at least 1 dose of AMG 397.
Groups in this outcome
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 1b: 80 mg AMG 397 | 4 |
| Part 1b: 160 mg AMG 397 | 5 |
| Part 1b: 320 mg AMG 397 | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1b: 80 mg AMG 397 | 0.0 | 0.00 | 0.00 | 60.24 | Not reported |
| Part 1b: 160 mg AMG 397 | 0.0 | 0.00 | 0.00 | 52.18 | Not reported |
| Part 1b: 320 mg AMG 397 | 0.0 | 0.00 | 0.00 | 70.76 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- spread
- 0.00
- upper Limit
- 60.24
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0.00
- spread
- 0.00
- upper Limit
- 52.18
- value
- 0.0
- group Id
- OG002
- lower Limit
- 0.00
- spread
- 0.00
- upper Limit
- 70.76
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- units
- Participants
- description
- ORR was assessed for participants with AML using response criteria per European Leukemia Network Response Criteria. ORR was defined as the percentage of participants who experienced either of the following based on investigator assessment: * PR * morphological leukemia-free state (MLFS) * complete remission with incomplete hematologic recovery (CRi) * complete remission * complete remission without minimal residual disease (CRmrd-).
- dispersion Type
- 95% Confidence Interval
- groups
- 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
- OG000
- 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
- OG001
- 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
- OG002
- title
- Part 1b: 320 mg AMG 397
- param Type
- NUMBER
- population Description
- Parts 2 and 3 were not initiated and did not enrol any participants, therefore results presented only included participants in part 1. Participants with AML were only enrolled in part 1b, so therefore data is only presented for part 1b. FAS: All participants who were enrolled and received at least 1 dose of AMG 397.
- reporting Status
- POSTED
- time Frame
- Up to end of study (a maximum of 48 weeks)
- title
- Overall Response Rate (ORR) for Participants With Acute Myeloid Leukemia (AML)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice