TriangleNCT04304144 · OUTCOME
Maximum Observed Plasma Concentration (Cmax) of CAEL-101
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- micrograms (µg)/milliliter (mL)
- Interval / dispersion
- Standard Deviation
- Time frame
- Predose through Week 1 and through Week 20
Analysis population: The Pharmacokinetic Set (PKS) included all participants who had at least 1 measurable plasma concentration. Number analyzed = participants evaluable at specified timepoint.
Groups in this outcome
Part A: CAEL-101 500 mg/m^2
Participants received CAEL-101 500 mg/m\^2 administered weekly as an IV infusion the first 4 weeks (DLT observation period), and thereafter received CAEL-101 at the RP3D (1000 mg/m\^2) every other week until the end of study.
Part A: CAEL-101 750 mg/m^2
Participants received CAEL-101 750 mg/m\^2 administered weekly as an IV infusion the first 4 weeks (DLT observation period), and thereafter received CAEL-101 at the RP3D (1000 mg/m\^2) every other week until the end of study.
Part A: CAEL-101 1000 mg/m^2
Participants received CAEL-101 1000 mg/m\^2 administered weekly as an IV infusion the first 4 weeks, and then every other week until the end of study.
Part B: CAEL-101 1000 mg/m^2
Participants received CAEL-101 at the RP3D (1000 mg/m\^2) administered weekly as an IV infusion for the first 4 weeks, and then every other week until end of study.
| Group | Source count |
|---|---|
| Part A: CAEL-101 500 mg/m^2 | 4 |
| Part A: CAEL-101 750 mg/m^2 | 3 |
| Part A: CAEL-101 1000 mg/m^2 | 6 |
| Part B: CAEL-101 1000 mg/m^2 | 12 |
Reported measurements
Week 1
| Group | Source count |
|---|---|
| Part A: CAEL-101 500 mg/m^2 | 4 |
| Part A: CAEL-101 750 mg/m^2 | 3 |
| Part A: CAEL-101 1000 mg/m^2 | 6 |
| Part B: CAEL-101 1000 mg/m^2 | 12 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: CAEL-101 500 mg/m^2 | 126 | 16.7 | Not reported | Not reported | Not reported |
| Part A: CAEL-101 750 mg/m^2 | 255 | 136 | Not reported | Not reported | Not reported |
| Part A: CAEL-101 1000 mg/m^2 | 244 | 92.8 | Not reported | Not reported | Not reported |
| Part B: CAEL-101 1000 mg/m^2 | 280 | 63.0 | Not reported | Not reported | Not reported |
Week 20
| Group | Source count |
|---|---|
| Part A: CAEL-101 500 mg/m^2 | 0 |
| Part A: CAEL-101 750 mg/m^2 | 0 |
| Part A: CAEL-101 1000 mg/m^2 | 6 |
| Part B: CAEL-101 1000 mg/m^2 | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: CAEL-101 1000 mg/m^2 | 580 | 270 | Not reported | Not reported | Not reported |
| Part B: CAEL-101 1000 mg/m^2 | 552 | 194 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 16.7
- value
- 126
- group Id
- OG001
- spread
- 136
- value
- 255
- group Id
- OG002
- spread
- 92.8
- value
- 244
- group Id
- OG003
- spread
- 63.0
- value
- 280
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 12
- units
- Participants
- title
- Week 1
- categories
- measurements
- group Id
- OG002
- spread
- 270
- value
- 580
- group Id
- OG003
- spread
- 194
- value
- 552
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 9
- units
- Participants
- title
- Week 20
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 12
- units
- Participants
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received CAEL-101 500 mg/m\^2 administered weekly as an IV infusion the first 4 weeks (DLT observation period), and thereafter received CAEL-101 at the RP3D (1000 mg/m\^2) every other week until the end of study.
- id
- OG000
- title
- Part A: CAEL-101 500 mg/m^2
- description
- Participants received CAEL-101 750 mg/m\^2 administered weekly as an IV infusion the first 4 weeks (DLT observation period), and thereafter received CAEL-101 at the RP3D (1000 mg/m\^2) every other week until the end of study.
- id
- OG001
- title
- Part A: CAEL-101 750 mg/m^2
- description
- Participants received CAEL-101 1000 mg/m\^2 administered weekly as an IV infusion the first 4 weeks, and then every other week until the end of study.
- id
- OG002
- title
- Part A: CAEL-101 1000 mg/m^2
- description
- Participants received CAEL-101 at the RP3D (1000 mg/m\^2) administered weekly as an IV infusion for the first 4 weeks, and then every other week until end of study.
- id
- OG003
- title
- Part B: CAEL-101 1000 mg/m^2
- param Type
- MEAN
- population Description
- The Pharmacokinetic Set (PKS) included all participants who had at least 1 measurable plasma concentration. Number analyzed = participants evaluable at specified timepoint.
- reporting Status
- POSTED
- time Frame
- Predose through Week 1 and through Week 20
- title
- Maximum Observed Plasma Concentration (Cmax) of CAEL-101
- type
- SECONDARY
- unit Of Measure
- micrograms (µg)/milliliter (mL)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice