TriangleNCT03687125 · OUTCOME
Phase 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Tinostamustine and Its Metabolites
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- nanogram per milliliter (ng/mL)
- Interval / dispersion
- Standard Deviation
- Time frame
- Pre-infusion, 0.50, 0.75, 1, 3, 6, 24, 48 hours post-infusion
What was measured
Cmax was defined as maximum observed plasma concentration. Tinostamustine (EDO-S101) and its metabolites included M2-EDO-S101 and M8-EDO-S101.
Analysis population: PK population included all participants in the safety population with at least one quantifiable pre-dose and one quantifiable post-dose PK plasma concentration. The study was early terminated on 17 April 2019, due to safety signals during Phase 1, participants were not enrolled in Phase 2.
Groups in this outcome
Tinostamustine 180 mg/m^2
Participants received single dose of tinostamustine 180 mg/m\^2 IV injection followed by autologous stem cell transplantation (ASCT) on Day 1.
Tinostamustine 220 mg/m^2
Participants received single dose of tinostamustine 220 mg/m\^2 IV injection followed by ASCT on Day 1.
| Group | Source count |
|---|---|
| Tinostamustine 180 mg/m^2 | 3 |
| Tinostamustine 220 mg/m^2 | 3 |
Reported measurements
EDO-S101
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tinostamustine 180 mg/m^2 | 2270 | 910 | Not reported | Not reported | Not reported |
| Tinostamustine 220 mg/m^2 | 3070 | 1320 | Not reported | Not reported | Not reported |
M2-EDO-S101
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tinostamustine 180 mg/m^2 | 2.85 | 1.45 | Not reported | Not reported | Not reported |
| Tinostamustine 220 mg/m^2 | 2.23 | 0.633 | Not reported | Not reported | Not reported |
M8-EDO-S101
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tinostamustine 180 mg/m^2 | 52.4 | 4.58 | Not reported | Not reported | Not reported |
| Tinostamustine 220 mg/m^2 | 60.4 | 11.5 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 910
- value
- 2270
- group Id
- OG001
- spread
- 1320
- value
- 3070
- title
- EDO-S101
- categories
- measurements
- group Id
- OG000
- spread
- 1.45
- value
- 2.85
- group Id
- OG001
- spread
- 0.633
- value
- 2.23
- title
- M2-EDO-S101
- categories
- measurements
- group Id
- OG000
- spread
- 4.58
- value
- 52.4
- group Id
- OG001
- spread
- 11.5
- value
- 60.4
- title
- M8-EDO-S101
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- Cmax was defined as maximum observed plasma concentration. Tinostamustine (EDO-S101) and its metabolites included M2-EDO-S101 and M8-EDO-S101.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received single dose of tinostamustine 180 mg/m\^2 IV injection followed by autologous stem cell transplantation (ASCT) on Day 1.
- id
- OG000
- title
- Tinostamustine 180 mg/m^2
- description
- Participants received single dose of tinostamustine 220 mg/m\^2 IV injection followed by ASCT on Day 1.
- id
- OG001
- title
- Tinostamustine 220 mg/m^2
- param Type
- MEAN
- population Description
- PK population included all participants in the safety population with at least one quantifiable pre-dose and one quantifiable post-dose PK plasma concentration. The study was early terminated on 17 April 2019, due to safety signals during Phase 1, participants were not enrolled in Phase 2.
- reporting Status
- POSTED
- time Frame
- Pre-infusion, 0.50, 0.75, 1, 3, 6, 24, 48 hours post-infusion
- title
- Phase 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Tinostamustine and Its Metabolites
- type
- SECONDARY
- unit Of Measure
- nanogram per milliliter (ng/mL)
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Preserved source evidence · Not medical advice