TriangleNCT05209152 · OUTCOME
Number of Participants With a Response According to the Uniform Response Criteria for MDS/Myeloproliferative Neoplasm (MPN)
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
- Cycle 1 to disease progression or end of study, whichever occurred earlier (cycle length = 28 days). Median time on study was 4.1 months
What was measured
A responder was assessed as having complete remission (CR) or partial remission (PR). Non-responders had stable disease, progressive disease or were not evaluable. CR: ≤ 5% myeloblasts with normal maturation of all cell lines and return to normal cellularity; osteomyelofibrosis was absent or equal to mild reticulin fibrosis; resolution of extramedullary disease present before therapy. PR: normalization of peripheral counts and hepatosplenomegaly with bone marrow blasts reduced by 50% but \>5% of cellularity except in cases of MDS/MPN with ≤ 5% blasts at baseline. Progression: ≥ 50% reduction from maximum response levels in granulocytes or platelets, and/or reduction in hemoglobin by ≥ 1.5 g/dL in the absence of another explanation; transfusion dependence.
Analysis population: The full analysis set included all enrolled participants who received at least 1 dose of AMG 176.
Groups in this outcome
Part 1A Dose Exploration: AMG 176 Dose Level 1
Participants received IV AMG 176 at dose level 1 once a week in 28-day cycles. Treatment was planned until disease progression or unacceptable toxicity.
Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2
Participants received IV AMG 176 at dose level 1 on cycle 1 day 1 and then dose level 2 from cycle 1 day 8 and once a week thereafter (each cycle = 28 days). Treatment was planned until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Part 1A Dose Exploration: AMG 176 Dose Level 1 | 4 |
| Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2 | 3 |
Reported measurements
Responders
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Dose Exploration: AMG 176 Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
Non-responders
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A Dose Exploration: AMG 176 Dose Level 1 | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2 | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Responders
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- title
- Non-responders
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- A responder was assessed as having complete remission (CR) or partial remission (PR). Non-responders had stable disease, progressive disease or were not evaluable. CR: ≤ 5% myeloblasts with normal maturation of all cell lines and return to normal cellularity; osteomyelofibrosis was absent or equal to mild reticulin fibrosis; resolution of extramedullary disease present before therapy. PR: normalization of peripheral counts and hepatosplenomegaly with bone marrow blasts reduced by 50% but \>5% of cellularity except in cases of MDS/MPN with ≤ 5% blasts at baseline. Progression: ≥ 50% reduction from maximum response levels in granulocytes or platelets, and/or reduction in hemoglobin by ≥ 1.5 g/dL in the absence of another explanation; transfusion dependence.
- groups
- description
- Participants received IV AMG 176 at dose level 1 once a week in 28-day cycles. Treatment was planned until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Part 1A Dose Exploration: AMG 176 Dose Level 1
- description
- Participants received IV AMG 176 at dose level 1 on cycle 1 day 1 and then dose level 2 from cycle 1 day 8 and once a week thereafter (each cycle = 28 days). Treatment was planned until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The full analysis set included all enrolled participants who received at least 1 dose of AMG 176.
- reporting Status
- POSTED
- time Frame
- Cycle 1 to disease progression or end of study, whichever occurred earlier (cycle length = 28 days). Median time on study was 4.1 months
- title
- Number of Participants With a Response According to the Uniform Response Criteria for MDS/Myeloproliferative Neoplasm (MPN)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice