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NCT01177397 · OUTCOME

Part B: Percent Change From Baseline in Levels of pAKT in Monocytes in the HCC and NET Cohorts by Dose

Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma · Source last updated 2022-12-13

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

HCC 30mg

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 45mg

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 30mg

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 45mg

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
HCC 30mg0
HCC 45mg16
NET 30mg0
NET 45mg4

Reported measurements

Day 1 1.5 hours post-dose

Analysis denominator · Participants

GroupSource count
HCC 30mg0
HCC 45mg16
NET 30mg0
NET 45mg4
Values in Percent change in pAKT · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
HCC 45mg-55.5Not reported-86.227.1Not reported
NET 45mg-70.3Not reported-83.7-51.2Not reported
Day 15 1.5 hours post-dose

Analysis denominator · Participants

GroupSource count
HCC 30mg0
HCC 45mg7
NET 30mg0
NET 45mg1
Values in Percent change in pAKT · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
HCC 45mg-84.1Not reported-87.7-19.5Not reported
NET 45mg-52.2Not reported-52.2-52.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        -86.2
        upper Limit
        27.1
        value
        -55.5
      2. group Id
        OG003
        lower Limit
        -83.7
        upper Limit
        -51.2
        value
        -70.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        16
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        4
      units
      Participants
    title
    Day 1 1.5 hours post-dose
  2. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        -87.7
        upper Limit
        -19.5
        value
        -84.1
      2. group Id
        OG003
        lower Limit
        -52.2
        upper Limit
        -52.2
        value
        -52.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      units
      Participants
    title
    Day 15 1.5 hours post-dose
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      4
    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
  1. 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 30mg
  2. 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 45mg
  3. 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 30mg
  4. 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 45mg
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 in the HCC and NET Cohorts by Dose
type
SECONDARY
unit Of Measure
Percent change in pAKT

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Preserved source evidence · Not medical advice