TriangleNCT01177397 · OUTCOME
Part B: Percent Change From Baseline in p4E-BP1 in Monocytes in the HCC and NET Cohorts by Dose
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: 1.5 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 monocytes via flow cytometry. MFI values were determined and converted to molecules of equivalent fluorescence label (MEFL) by normalizing against calibration beads. 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. Data is reported by T-cell subsets known as clusters of differentiation (CD).
Analysis population: All biomarker evaluable participants who received treatment in Part B.
Groups in this outcome
HCC 30 mg
Participants with HCC received a 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.
HCC 45 mg
Participants with HCC received a 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.
NET 30 mg
Participants with NET received a 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.
NET 45 mg
Participants with NET received a 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.
| Group | Source count |
|---|---|
| HCC 30 mg | 20 |
| HCC 45 mg | 6 |
| NET 30 mg | 21 |
| NET 45 mg | 13 |
Reported measurements
Day 1 1.5 hours post-dose - CD3+
| Group | Source count |
|---|---|
| HCC 30 mg | 20 |
| HCC 45 mg | 4 |
| NET 30 mg | 21 |
| NET 45 mg | 12 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HCC 30 mg | -28.3 | Not reported | -100.0 | 127.6 | Not reported |
| HCC 45 mg | 20.0 | Not reported | -69.1 | 157.1 | Not reported |
| NET 30 mg | -40.4 | Not reported | -93.6 | 11.6 | Not reported |
| NET 45 mg | -70.6 | Not reported | -90.0 | 114.3 | Not reported |
Day 15 1.5 hours post-dose - CD3+
| Group | Source count |
|---|---|
| HCC 30 mg | 15 |
| HCC 45 mg | 3 |
| NET 30 mg | 15 |
| NET 45 mg | 7 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HCC 30 mg | -34.0 | Not reported | -100.0 | 445.8 | Not reported |
| HCC 45 mg | -52.8 | Not reported | -62.6 | 52.4 | Not reported |
| NET 30 mg | -39.7 | Not reported | -95.7 | 33.8 | Not reported |
| NET 45 mg | -70.2 | Not reported | -98.9 | 105.0 | Not reported |
Day 1 1.5 hours post-dose - CD14+
| Group | Source count |
|---|---|
| HCC 30 mg | 20 |
| HCC 45 mg | 6 |
| NET 30 mg | 21 |
| NET 45 mg | 13 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HCC 30 mg | -22.1 | Not reported | -87.0 | 28.9 | Not reported |
| HCC 45 mg | 7.0 | Not reported | -50.6 | 66.6 | Not reported |
| NET 30 mg | -8.7 | Not reported | -54.7 | 25.8 | Not reported |
| NET 45 mg | -36.6 | Not reported | -85.3 | 46.3 | Not reported |
Day 15 1.5 hours post-dose - CD14+
| Group | Source count |
|---|---|
| HCC 30 mg | 15 |
| HCC 45 mg | 4 |
| NET 30 mg | 15 |
| NET 45 mg | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HCC 30 mg | -58.1 | Not reported | -91.7 | 528.1 | Not reported |
| HCC 45 mg | -28.4 | Not reported | -67.5 | 111.6 | Not reported |
| NET 30 mg | -25.6 | Not reported | -78.7 | 26.0 | Not reported |
| NET 45 mg | -47.4 | Not reported | -68.3 | 23.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -100.0
- upper Limit
- 127.6
- value
- -28.3
- group Id
- OG001
- lower Limit
- -69.1
- upper Limit
- 157.1
- value
- 20.0
- group Id
- OG002
- lower Limit
- -93.6
- upper Limit
- 11.6
- value
- -40.4
- group Id
- OG003
- lower Limit
- -90.0
- upper Limit
- 114.3
- value
- -70.6
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 12
- units
- Participants
- title
- Day 1 1.5 hours post-dose - CD3+
- categories
- measurements
- group Id
- OG000
- lower Limit
- -100.0
- upper Limit
- 445.8
- value
- -34.0
- group Id
- OG001
- lower Limit
- -62.6
- upper Limit
- 52.4
- value
- -52.8
- group Id
- OG002
- lower Limit
- -95.7
- upper Limit
- 33.8
- value
- -39.7
- group Id
- OG003
- lower Limit
- -98.9
- upper Limit
- 105.0
- value
- -70.2
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 7
- units
- Participants
- title
- Day 15 1.5 hours post-dose - CD3+
- categories
- measurements
- group Id
- OG000
- lower Limit
- -87.0
- upper Limit
- 28.9
- value
- -22.1
- group Id
- OG001
- lower Limit
- -50.6
- upper Limit
- 66.6
- value
- 7.0
- group Id
- OG002
- lower Limit
- -54.7
- upper Limit
- 25.8
- value
- -8.7
- group Id
- OG003
- lower Limit
- -85.3
- upper Limit
- 46.3
- value
- -36.6
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 13
- units
- Participants
- title
- Day 1 1.5 hours post-dose - CD14+
- categories
- measurements
- group Id
- OG000
- lower Limit
- -91.7
- upper Limit
- 528.1
- value
- -58.1
- group Id
- OG001
- lower Limit
- -67.5
- upper Limit
- 111.6
- value
- -28.4
- group Id
- OG002
- lower Limit
- -78.7
- upper Limit
- 26.0
- value
- -25.6
- group Id
- OG003
- lower Limit
- -68.3
- upper Limit
- 23.2
- value
- -47.4
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 8
- units
- Participants
- title
- Day 15 1.5 hours post-dose - CD14+
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 13
- 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 monocytes via flow cytometry. MFI values were determined and converted to molecules of equivalent fluorescence label (MEFL) by normalizing against calibration beads. 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. Data is reported by T-cell subsets known as clusters of differentiation (CD).
- dispersion Type
- Full Range
- groups
- description
- Participants with HCC received a 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
- OG000
- title
- HCC 30 mg
- description
- Participants with HCC received a 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
- OG001
- title
- HCC 45 mg
- description
- Participants with NET received a 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
- NET 30 mg
- description
- Participants with NET received a 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
- NET 45 mg
- param Type
- MEDIAN
- population Description
- All biomarker evaluable participants who received treatment in Part B.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1: 1.5 hours post-dose and Day 15: 1.5 hours post-dose
- title
- Part B: Percent Change From Baseline in p4E-BP1 in Monocytes in the HCC and NET Cohorts by Dose
- type
- SECONDARY
- unit Of Measure
- Percent change in p4E-BP1
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Preserved source evidence · Not medical advice