TriangleNCT04582539 · OUTCOME
AUClast of Zilurgisertib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- nanomolar x hour
- Interval / dispersion
- Standard Deviation
- Time frame
- Days 1 and 15 of Cycle 1: pre-dose; 2, 4, and 6-8 hours post-dose
What was measured
AUClast was defined as the area under the plasma concentration-time curve from time 0 to the last quantifiable measurable plasma concentration of zilurgisertib.
Analysis population: PK Evaluable Population. Only participants with available data were analyzed. One participant who was supposed to receive 100 mg actually received 25 mg from Day 1 to Day 16.
Groups in this outcome
Zilurgisertib 25 mg QD
Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 25 milligrams (mg) once daily (QD) administered as a monotherapy from Day 1 to Day 16.
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 25 mg QD | 1 |
| Zilurgisertib 50 mg QD | 4 |
| Zilurgisertib 100 mg QD | 4 |
| Zilurgisertib 200 mg QD | 4 |
| Zilurgisertib 400 mg QD | 4 |
| Zilurgisertib 600 mg QD | 2 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Zilurgisertib 25 mg QD | 1 |
| Zilurgisertib 50 mg QD | 4 |
| Zilurgisertib 100 mg QD | 4 |
| Zilurgisertib 200 mg QD | 4 |
| Zilurgisertib 400 mg QD | 4 |
| Zilurgisertib 600 mg QD | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zilurgisertib 25 mg QD | 343 | NA | Not reported | Not reported | Standard deviation was not calculated for a single participant. |
| Zilurgisertib 50 mg QD | 749 | 312 | Not reported | Not reported | Not reported |
| Zilurgisertib 100 mg QD | 1070 | 471 | Not reported | Not reported | Not reported |
| Zilurgisertib 200 mg QD | 2540 | 1150 | Not reported | Not reported | Not reported |
| Zilurgisertib 400 mg QD | 8050 | 2680 | Not reported | Not reported | Not reported |
| Zilurgisertib 600 mg QD | NA | NA | Not reported | Not reported | Two participants had values above the upper limit of quantification, meaning data for PK parameters could not be determined. |
Cycle 1 Day 15
| Group | Source count |
|---|---|
| Zilurgisertib 25 mg QD | 0 |
| Zilurgisertib 50 mg QD | 4 |
| Zilurgisertib 100 mg QD | 4 |
| Zilurgisertib 200 mg QD | 4 |
| Zilurgisertib 400 mg QD | 2 |
| Zilurgisertib 600 mg QD | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zilurgisertib 50 mg QD | 1890 | 749 | Not reported | Not reported | Not reported |
| Zilurgisertib 100 mg QD | 3090 | 1620 | Not reported | Not reported | Not reported |
| Zilurgisertib 200 mg QD | 6850 | 3050 | Not reported | Not reported | Not reported |
| Zilurgisertib 400 mg QD | 12300 | 26100 | Not reported | Not reported | Not reported |
| Zilurgisertib 600 mg QD | NA | NA | Not reported | Not reported | Two participants had values above the upper limit of quantification, meaning data for PK parameters could not be determined. |
Complete source fields
- classes
- categories
- measurements
- comment
- Standard deviation was not calculated for a single participant.
- group Id
- OG000
- spread
- NA
- value
- 343
- group Id
- OG001
- spread
- 312
- value
- 749
- group Id
- OG002
- spread
- 471
- value
- 1070
- group Id
- OG003
- spread
- 1150
- value
- 2540
- group Id
- OG004
- spread
- 2680
- value
- 8050
- comment
- Two participants had values above the upper limit of quantification, meaning data for PK parameters could not be determined.
- group Id
- OG005
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 2
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG001
- spread
- 749
- value
- 1890
- group Id
- OG002
- spread
- 1620
- value
- 3090
- group Id
- OG003
- spread
- 3050
- value
- 6850
- group Id
- OG004
- spread
- 26100
- value
- 12300
- comment
- Two participants had values above the upper limit of quantification, meaning data for PK parameters could not be determined.
- group Id
- OG005
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 2
- units
- Participants
- title
- Cycle 1 Day 15
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 2
- units
- Participants
- description
- AUClast was defined as the area under the plasma concentration-time curve from time 0 to the last quantifiable measurable plasma concentration of zilurgisertib.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with myelodysplastic syndromes (MDS) or multiple myeloma (MM) who were transfusion dependent or presented with symptomatic anemia received oral zilurgisertib 25 milligrams (mg) once daily (QD) administered as a monotherapy from Day 1 to Day 16.
- id
- OG000
- title
- Zilurgisertib 25 mg QD
- 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
- OG001
- 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
- OG002
- 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
- OG003
- 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
- OG004
- 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
- OG005
- title
- Zilurgisertib 600 mg QD
- param Type
- MEAN
- population Description
- PK Evaluable Population. Only participants with available data were analyzed. One participant who was supposed to receive 100 mg actually received 25 mg from Day 1 to Day 16.
- reporting Status
- POSTED
- time Frame
- Days 1 and 15 of Cycle 1: pre-dose; 2, 4, and 6-8 hours post-dose
- title
- AUClast of Zilurgisertib
- type
- SECONDARY
- unit Of Measure
- nanomolar x hour
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Preserved source evidence · Not medical advice