TriangleNCT04582539 · OUTCOME
Overall Response Rate (ORR) in MDS Participants
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 920 days
What was measured
ORR was defined as the percentage of participants with complete response (CR) or partial response (PR). For MDS, CR: bone marrow with ≤5% myeloblasts with normal maturation of all cell lines; HgB ≥11 g/dl, neutrophils ≥1.0x10\^9/Liter (L), platelets ≥100x10\^9/L, and no blasts in the peripheral blood. For MDS, PR: all CR criteria, but bone marrow blasts decreased by ≥50% over pretreatment but still \>5%; cellularity and morphology not relevant. For MDS/MPN overlap syndromes, CR: bone marrow with ≤5% myeloblasts; no osteomyelofibrosis or ≤Grade 1 fibrosis; white blood cells ≤10X10\^9 cells/L, HgB ≥11 g/dL, platelets ≥100x10\^9/L/≤450x10\^9/L, neutrophils ≥1.0x10\^9/L, no blasts, neutrophil precursors reduced to ≤2%, monocytes ≤1x10\^9/L in peripheral blood; complete resolution of medullary disease. For MDS/MPN overlap syndromes, PR: normalization of peripheral counts and hepatosplenomegaly with bone marrow blasts reduced by 50%, but remaining \>5% of cellularity.
Analysis population: Full Analysis Set-MDS only. Participants with MDS/MPN overlap syndromes were excluded from analysis. The 95% confidence interval was calculated using exact binomial distribution.
Groups in this outcome
Zilurgisertib 50 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
Zilurgisertib 100 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
Zilurgisertib 200 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
Zilurgisertib 400 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
Zilurgisertib 600 mg QD
Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
| Group | Source count |
|---|---|
| Zilurgisertib 50 mg QD | 4 |
| Zilurgisertib 100 mg QD | 4 |
| Zilurgisertib 200 mg QD | 3 |
| Zilurgisertib 400 mg QD | 5 |
| Zilurgisertib 600 mg QD | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zilurgisertib 50 mg QD | 0.0 | Not reported | 0.0 | 60.2 | Not reported |
| Zilurgisertib 100 mg QD | 0.0 | Not reported | 0.0 | 60.2 | Not reported |
| Zilurgisertib 200 mg QD | 0.0 | Not reported | 0.0 | 70.8 | Not reported |
| Zilurgisertib 400 mg QD | 0.0 | Not reported | 0.0 | 52.2 | Not reported |
| Zilurgisertib 600 mg QD | 0.0 | Not reported | 0.0 | 70.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 60.2
- value
- 0.0
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 60.2
- value
- 0.0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 70.8
- value
- 0.0
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 52.2
- value
- 0.0
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 70.8
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 3
- units
- Participants
- description
- ORR was defined as the percentage of participants with complete response (CR) or partial response (PR). For MDS, CR: bone marrow with ≤5% myeloblasts with normal maturation of all cell lines; HgB ≥11 g/dl, neutrophils ≥1.0x10\^9/Liter (L), platelets ≥100x10\^9/L, and no blasts in the peripheral blood. For MDS, PR: all CR criteria, but bone marrow blasts decreased by ≥50% over pretreatment but still \>5%; cellularity and morphology not relevant. For MDS/MPN overlap syndromes, CR: bone marrow with ≤5% myeloblasts; no osteomyelofibrosis or ≤Grade 1 fibrosis; white blood cells ≤10X10\^9 cells/L, HgB ≥11 g/dL, platelets ≥100x10\^9/L/≤450x10\^9/L, neutrophils ≥1.0x10\^9/L, no blasts, neutrophil precursors reduced to ≤2%, monocytes ≤1x10\^9/L in peripheral blood; complete resolution of medullary disease. For MDS/MPN overlap syndromes, PR: normalization of peripheral counts and hepatosplenomegaly with bone marrow blasts reduced by 50%, but remaining \>5% of cellularity.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 50 milligrams (mg) once daily (QD) administered as a monotherapy for up to 6 months.
- id
- OG000
- title
- Zilurgisertib 50 mg QD
- description
- Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 100 mg QD administered as a monotherapy for up to 6 months.
- id
- OG001
- title
- Zilurgisertib 100 mg QD
- description
- Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 200 mg QD administered as a monotherapy for up to 6 months.
- id
- OG002
- title
- Zilurgisertib 200 mg QD
- description
- Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 400 mg QD administered as a monotherapy for up to 6 months.
- id
- OG003
- title
- Zilurgisertib 400 mg QD
- description
- Participants with MDS or MM who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 600 mg QD administered as a monotherapy for up to 6 months.
- id
- OG004
- title
- Zilurgisertib 600 mg QD
- param Type
- NUMBER
- population Description
- Full Analysis Set-MDS only. Participants with MDS/MPN overlap syndromes were excluded from analysis. The 95% confidence interval was calculated using exact binomial distribution.
- reporting Status
- POSTED
- time Frame
- up to 920 days
- title
- Overall Response Rate (ORR) in MDS Participants
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice