TriangleNCT01177397 · OUTCOME
Part A: Terminal Elimination Phase Half-Life (T1/2) of CC-223
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Hours
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1 Day -1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose
What was measured
Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. T1/2 was not assessed following multiple dosing as the blood sampling schedule on Day 15 did not allow robust assessment of the terminal elimination rate constant.
Analysis population: All treated participants with available pharmacokinetic data in Part A.
Groups in this outcome
Part A: CC-223 7.5 mg
Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Part A: CC-223 15 mg
Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Part A: CC-223 30 mg
Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Part A: CC-223 45 mg
Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
Part A: CC-223 60 mg
Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
| Group | Source count |
|---|---|
| Part A: CC-223 7.5 mg | 1 |
| Part A: CC-223 15 mg | 2 |
| Part A: CC-223 30 mg | 8 |
| Part A: CC-223 45 mg | 8 |
| Part A: CC-223 60 mg | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: CC-223 7.5 mg | 7.68 | NA | Not reported | Not reported | Insufficient data values to calculate coefficient of variation. |
| Part A: CC-223 15 mg | 3.35 | 54.1 | Not reported | Not reported | Not reported |
| Part A: CC-223 30 mg | 5.57 | 38.4 | Not reported | Not reported | Not reported |
| Part A: CC-223 45 mg | 4.86 | 25.9 | Not reported | Not reported | Not reported |
| Part A: CC-223 60 mg | 5.64 | 16.7 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Insufficient data values to calculate coefficient of variation.
- group Id
- OG000
- spread
- NA
- value
- 7.68
- group Id
- OG001
- spread
- 54.1
- value
- 3.35
- group Id
- OG002
- spread
- 38.4
- value
- 5.57
- group Id
- OG003
- spread
- 25.9
- value
- 4.86
- group Id
- OG004
- spread
- 16.7
- value
- 5.64
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 6
- units
- Participants
- description
- Plasma CC-223 was measured using validated chiral liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. T1/2 was not assessed following multiple dosing as the blood sampling schedule on Day 15 did not allow robust assessment of the terminal elimination rate constant.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG000
- title
- Part A: CC-223 7.5 mg
- description
- Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG001
- title
- Part A: CC-223 15 mg
- description
- Participants received a single dose of 30 mg CC-223 on Day -1, then daily dosing of 30 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG002
- title
- Part A: CC-223 30 mg
- description
- Participants received a single dose of 45 mg CC-223 on Day -1, then daily dosing of 45 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG003
- title
- Part A: CC-223 45 mg
- description
- Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 mg CC-223 for 28 days beginning on Day 1. Participants received subsequent cycles consisting of 28-day continuous dosing without rest between cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG004
- title
- Part A: CC-223 60 mg
- param Type
- GEOMETRIC_MEAN
- population Description
- All treated participants with available pharmacokinetic data in Part A.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day -1: pre-dose, 0.5, 1, 1.5, 3, 5, 8, 24 and 48 hours post-dose
- title
- Part A: Terminal Elimination Phase Half-Life (T1/2) of CC-223
- type
- PRIMARY
- unit Of Measure
- Hours
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Preserved source evidence · Not medical advice