TriangleNCT01177397 · OUTCOME
Part B: Percent Change From Baseline in Levels of pAKT in Monocytes by Tumor Cohort
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Percent change in pAKT
- 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 AKT is a biomarker for inhibition of the mammalian target of rapamycin complex 2 (mTORC2). Phosphorylated AKT 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.
Analysis population: All biomarker evaluable participants who received treatment in Part B.
Groups in this outcome
Part B: Non-small Cell Lung Cancer (NSCLC)
Participants with NSCLC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
Part B: Glioblastoma Multiforme (GBM)
Participants with GBM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
Part B: Hepatocellular Carcinoma (HCC)
Participants with HCC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
Part B: Neuroendocrine Tumor (NET)
Participants with NET received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
Part B: Diffuse Large B-cell Lymphoma (DLBCL)
Participants with DLBCL received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
Part B: Multiple Myeloma (MM)
Participants with MM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
Part B: Hormone Receptor Positive Breast Cancer (HRPBC)
Participants with HRPBC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
| Group | Source count |
|---|---|
| Part B: Non-small Cell Lung Cancer (NSCLC) | 16 |
| Part B: Glioblastoma Multiforme (GBM) | 8 |
| Part B: Hepatocellular Carcinoma (HCC) | 16 |
| Part B: Neuroendocrine Tumor (NET) | 4 |
| Part B: Diffuse Large B-cell Lymphoma (DLBCL) | 2 |
| Part B: Multiple Myeloma (MM) | 4 |
| Part B: Hormone Receptor Positive Breast Cancer (HRPBC) | 1 |
Reported measurements
Day 1 1.5 hours post-dose
| Group | Source count |
|---|---|
| Part B: Non-small Cell Lung Cancer (NSCLC) | 16 |
| Part B: Glioblastoma Multiforme (GBM) | 8 |
| Part B: Hepatocellular Carcinoma (HCC) | 16 |
| Part B: Neuroendocrine Tumor (NET) | 4 |
| Part B: Diffuse Large B-cell Lymphoma (DLBCL) | 2 |
| Part B: Multiple Myeloma (MM) | 4 |
| Part B: Hormone Receptor Positive Breast Cancer (HRPBC) | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Non-small Cell Lung Cancer (NSCLC) | -68.1 | Not reported | -86.5 | 43.9 | Not reported |
| Part B: Glioblastoma Multiforme (GBM) | -28.0 | Not reported | -73.0 | 130.1 | Not reported |
| Part B: Hepatocellular Carcinoma (HCC) | -55.5 | Not reported | -86.2 | 27.1 | Not reported |
| Part B: Neuroendocrine Tumor (NET) | -70.3 | Not reported | -83.7 | -51.2 | Not reported |
| Part B: Diffuse Large B-cell Lymphoma (DLBCL) | -54.3 | Not reported | -89.0 | -19.6 | Not reported |
| Part B: Multiple Myeloma (MM) | -78.8 | Not reported | -86.2 | -27.1 | Not reported |
| Part B: Hormone Receptor Positive Breast Cancer (HRPBC) | -53.8 | Not reported | -53.8 | -53.8 | Not reported |
Day 15 1.5 hours post-dose
| Group | Source count |
|---|---|
| Part B: Non-small Cell Lung Cancer (NSCLC) | 8 |
| Part B: Glioblastoma Multiforme (GBM) | 8 |
| Part B: Hepatocellular Carcinoma (HCC) | 7 |
| Part B: Neuroendocrine Tumor (NET) | 1 |
| Part B: Diffuse Large B-cell Lymphoma (DLBCL) | 1 |
| Part B: Multiple Myeloma (MM) | 2 |
| Part B: Hormone Receptor Positive Breast Cancer (HRPBC) | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part B: Non-small Cell Lung Cancer (NSCLC) | -76.1 | Not reported | -93.0 | -27.5 | Not reported |
| Part B: Glioblastoma Multiforme (GBM) | -34.1 | Not reported | -89.8 | 48.6 | Not reported |
| Part B: Hepatocellular Carcinoma (HCC) | -84.1 | Not reported | -87.7 | -19.5 | Not reported |
| Part B: Neuroendocrine Tumor (NET) | -52.2 | Not reported | -52.2 | -52.2 | Not reported |
| Part B: Diffuse Large B-cell Lymphoma (DLBCL) | -88.6 | Not reported | -88.6 | -88.6 | Not reported |
| Part B: Multiple Myeloma (MM) | -52.9 | Not reported | -77.5 | -28.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -86.5
- upper Limit
- 43.9
- value
- -68.1
- group Id
- OG001
- lower Limit
- -73.0
- upper Limit
- 130.1
- value
- -28.0
- group Id
- OG002
- lower Limit
- -86.2
- upper Limit
- 27.1
- value
- -55.5
- group Id
- OG003
- lower Limit
- -83.7
- upper Limit
- -51.2
- value
- -70.3
- group Id
- OG004
- lower Limit
- -89.0
- upper Limit
- -19.6
- value
- -54.3
- group Id
- OG005
- lower Limit
- -86.2
- upper Limit
- -27.1
- value
- -78.8
- group Id
- OG006
- lower Limit
- -53.8
- upper Limit
- -53.8
- value
- -53.8
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 16
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 1
- units
- Participants
- title
- Day 1 1.5 hours post-dose
- categories
- measurements
- group Id
- OG000
- lower Limit
- -93.0
- upper Limit
- -27.5
- value
- -76.1
- group Id
- OG001
- lower Limit
- -89.8
- upper Limit
- 48.6
- value
- -34.1
- group Id
- OG002
- lower Limit
- -87.7
- upper Limit
- -19.5
- value
- -84.1
- group Id
- OG003
- lower Limit
- -52.2
- upper Limit
- -52.2
- value
- -52.2
- group Id
- OG004
- lower Limit
- -88.6
- upper Limit
- -88.6
- value
- -88.6
- group Id
- OG005
- lower Limit
- -77.5
- upper Limit
- -28.2
- value
- -52.9
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 0
- units
- Participants
- title
- Day 15 1.5 hours post-dose
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 16
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 1
- units
- Participants
- description
- Phosphorylated AKT is a biomarker for inhibition of the mammalian target of rapamycin complex 2 (mTORC2). Phosphorylated AKT 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.
- dispersion Type
- Full Range
- groups
- description
- Participants with NSCLC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG000
- title
- Part B: Non-small Cell Lung Cancer (NSCLC)
- description
- Participants with GBM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG001
- title
- Part B: Glioblastoma Multiforme (GBM)
- description
- Participants with HCC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG002
- title
- Part B: Hepatocellular Carcinoma (HCC)
- description
- Participants with NET received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG003
- title
- Part B: Neuroendocrine Tumor (NET)
- description
- Participants with DLBCL received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG004
- title
- Part B: Diffuse Large B-cell Lymphoma (DLBCL)
- description
- Participants with MM received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG005
- title
- Part B: Multiple Myeloma (MM)
- description
- Participants with HRPBC received CC-223 at a starting dose of 45 mg/day (reduced to 30 mg/day after protocol Amendment 9) orally once a day in 28-day cycles for as long as they derived benefit from treatment as judged by the investigator.
- id
- OG006
- title
- Part B: Hormone Receptor Positive Breast Cancer (HRPBC)
- 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 Levels of pAKT in Monocytes by Tumor Cohort
- type
- SECONDARY
- unit Of Measure
- Percent change in pAKT
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Preserved source evidence · Not medical advice