TriangleNCT01177397 · OUTCOME
Part A: Percent Change From Baseline in Levels of Phosphorylated Elongation I Initiation Binding Protein (p4E-BP1) in Stimulated T Cells
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Percent change in p4E-BP1
- Interval / dispersion
- Full Range
- Time frame
- Cycle 1 Day -1: 3 hours post-dose and Day 15: 1.5 hours post-dose
What was measured
Phosphorylated 4E-BP1 is a biomarker for inhibition of the mammalian target of rapamycin complex 1 (mTORC1). Phosphorylated 4E-BP1 was measured in stimulated T cells via flow cytometry. The raw measurements were expressed as median fluorescence intensity (MFI). MFI values were normalized against calibration beads using a linear regression transformation carried out on a log-log scale and reported as equivalent reference fluorophores (ERF). The biomarker evaluable population included all subjects who took at least one dose of study drug and had at least one non-missing pharmacodynamic (PD) assessment. Results were not available for the single subject treated in the 7.5-mg dose group and for one of the two subjects treated in the 15-mg dose group.
Analysis population: All biomarker evaluable participants who received treatment 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 | 0 |
| Part A: CC-223 15 mg | 1 |
| Part A: CC-223 30 mg | 9 |
| Part A: CC-223 45 mg | 8 |
| Part A: CC-223 60 mg | 7 |
Reported measurements
Day -1 3 hours post-dose
| Group | Source count |
|---|---|
| Part A: CC-223 7.5 mg | 0 |
| Part A: CC-223 15 mg | 1 |
| Part A: CC-223 30 mg | 9 |
| Part A: CC-223 45 mg | 8 |
| Part A: CC-223 60 mg | 7 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: CC-223 15 mg | -20.7 | Not reported | -20.7 | -20.7 | Not reported |
| Part A: CC-223 30 mg | -44.0 | Not reported | -65.1 | -28.7 | Not reported |
| Part A: CC-223 45 mg | -55.7 | Not reported | -71.2 | -26.4 | Not reported |
| Part A: CC-223 60 mg | -44.3 | Not reported | -63.7 | -1.0 | Not reported |
Day 15 1.5 hours post-dose
| Group | Source count |
|---|---|
| Part A: CC-223 7.5 mg | 0 |
| Part A: CC-223 15 mg | 1 |
| Part A: CC-223 30 mg | 6 |
| Part A: CC-223 45 mg | 4 |
| Part A: CC-223 60 mg | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A: CC-223 15 mg | -14.4 | Not reported | -14.4 | -14.4 | Not reported |
| Part A: CC-223 30 mg | -61.1 | Not reported | -92.8 | -44.5 | Not reported |
| Part A: CC-223 45 mg | -54.8 | Not reported | -61.8 | -34.4 | Not reported |
| Part A: CC-223 60 mg | -46.4 | Not reported | -69.8 | -26.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- lower Limit
- -20.7
- upper Limit
- -20.7
- value
- -20.7
- group Id
- OG002
- lower Limit
- -65.1
- upper Limit
- -28.7
- value
- -44.0
- group Id
- OG003
- lower Limit
- -71.2
- upper Limit
- -26.4
- value
- -55.7
- group Id
- OG004
- lower Limit
- -63.7
- upper Limit
- -1.0
- value
- -44.3
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 7
- units
- Participants
- title
- Day -1 3 hours post-dose
- categories
- measurements
- group Id
- OG001
- lower Limit
- -14.4
- upper Limit
- -14.4
- value
- -14.4
- group Id
- OG002
- lower Limit
- -92.8
- upper Limit
- -44.5
- value
- -61.1
- group Id
- OG003
- lower Limit
- -61.8
- upper Limit
- -34.4
- value
- -54.8
- group Id
- OG004
- lower Limit
- -69.8
- upper Limit
- -26.3
- value
- -46.4
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 4
- units
- Participants
- title
- Day 15 1.5 hours post-dose
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 7
- units
- Participants
- description
- Phosphorylated 4E-BP1 is a biomarker for inhibition of the mammalian target of rapamycin complex 1 (mTORC1). Phosphorylated 4E-BP1 was measured in stimulated T cells via flow cytometry. The raw measurements were expressed as median fluorescence intensity (MFI). MFI values were normalized against calibration beads using a linear regression transformation carried out on a log-log scale and reported as equivalent reference fluorophores (ERF). The biomarker evaluable population included all subjects who took at least one dose of study drug and had at least one non-missing pharmacodynamic (PD) assessment. Results were not available for the single subject treated in the 7.5-mg dose group and for one of the two subjects treated in the 15-mg dose group.
- dispersion Type
- Full Range
- 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
- MEDIAN
- population Description
- All biomarker evaluable participants who received treatment in Part A.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day -1: 3 hours post-dose and Day 15: 1.5 hours post-dose
- title
- Part A: Percent Change From Baseline in Levels of Phosphorylated Elongation I Initiation Binding Protein (p4E-BP1) in Stimulated T Cells
- type
- SECONDARY
- unit Of Measure
- Percent change in p4E-BP1
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Preserved source evidence · Not medical advice