TriangleNCT00985959 · OUTCOME
Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 in Combination With Melphalan and Prednisolone) - Phase I
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Day 4 of Cycle 2
What was measured
Cmax of bortezomib following intravenous administration of JNJ-26866138 at dose of 0.7, 1.0, and 1.3 mg/m2 on Cycle 2/Day 4 (combination with melphalan and prednisolone)
Analysis population: Pharmacokinetics-evaluable population: 14 participants were included in pharmacokinetics-evaluable population during Cycle 2
Groups in this outcome
Phase I - JNJ-26866138 0.7 mg/m2 Group
JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
Phase I - JNJ-26866138 1.0 mg/m2 Group
JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
Phase I - JNJ-26866138 1.3 mg/m2 Group
JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
| Group | Source count |
|---|---|
| Phase I - JNJ-26866138 0.7 mg/m2 Group | 6 |
| Phase I - JNJ-26866138 1.0 mg/m2 Group | 5 |
| Phase I - JNJ-26866138 1.3 mg/m2 Group | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I - JNJ-26866138 0.7 mg/m2 Group | 34.40 | 5.7986 | Not reported | Not reported | Not reported |
| Phase I - JNJ-26866138 1.0 mg/m2 Group | 69.50 | 19.455 | Not reported | Not reported | Not reported |
| Phase I - JNJ-26866138 1.3 mg/m2 Group | 88.87 | 19.568 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 5.7986
- value
- 34.40
- group Id
- OG001
- spread
- 19.455
- value
- 69.50
- group Id
- OG002
- spread
- 19.568
- value
- 88.87
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- units
- Participants
- description
- Cmax of bortezomib following intravenous administration of JNJ-26866138 at dose of 0.7, 1.0, and 1.3 mg/m2 on Cycle 2/Day 4 (combination with melphalan and prednisolone)
- dispersion Type
- Standard Deviation
- groups
- description
- JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
- id
- OG000
- title
- Phase I - JNJ-26866138 0.7 mg/m2 Group
- description
- JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
- id
- OG001
- title
- Phase I - JNJ-26866138 1.0 mg/m2 Group
- description
- JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
- id
- OG002
- title
- Phase I - JNJ-26866138 1.3 mg/m2 Group
- param Type
- MEAN
- population Description
- Pharmacokinetics-evaluable population: 14 participants were included in pharmacokinetics-evaluable population during Cycle 2
- reporting Status
- POSTED
- time Frame
- Day 4 of Cycle 2
- title
- Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 in Combination With Melphalan and Prednisolone) - Phase I
- type
- SECONDARY
- unit Of Measure
- ng/mL
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Preserved source evidence · Not medical advice