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NCT01177397 · OUTCOME

Part B: Percent Change From Baseline in pS6RP Levels in Tumor Tissue by Tumor Type

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 pS6RP
Interval / dispersion
Full Range
Time frame
Up to Cycle 1 Day 15 3 hours post dose

What was measured

Tumor tissue biopsies were performed at Baseline and on Day 15 3 hours post dose. Levels of pS6RP were quantified using immunohistochemical (IHC) methods.

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

Analysis denominator · Participants

GroupSource count
Part B: Non-small Cell Lung Cancer (NSCLC)6
Part B: Glioblastoma Multiforme (GBM)1
Part B: Hepatocellular Carcinoma (HCC)3
Part B: Neuroendocrine Tumor (NET)1
Part B: Diffuse Large B-cell Lymphoma (DLBCL)9
Part B: Multiple Myeloma (MM)0
Part B: Hormone Receptor Positive Breast Cancer (HRPBC)3

Reported measurements

Source class 1
Values in Percent change in pS6RP · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part B: Non-small Cell Lung Cancer (NSCLC)22-37-3766Not reported
Part B: Glioblastoma Multiforme (GBM)-36-36-36-36Not reported
Part B: Hepatocellular Carcinoma (HCC)-19-37-3724Not reported
Part B: Neuroendocrine Tumor (NET)-30-30-30-30Not reported
Part B: Diffuse Large B-cell Lymphoma (DLBCL)-21-43-4312Not reported
Part B: Hormone Receptor Positive Breast Cancer (HRPBC)-15-17-176Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -37
        spread
        -37
        upper Limit
        66
        value
        22
      2. group Id
        OG001
        lower Limit
        -36
        spread
        -36
        upper Limit
        -36
        value
        -36
      3. group Id
        OG002
        lower Limit
        -37
        spread
        -37
        upper Limit
        24
        value
        -19
      4. group Id
        OG003
        lower Limit
        -30
        spread
        -30
        upper Limit
        -30
        value
        -30
      5. group Id
        OG004
        lower Limit
        -43
        spread
        -43
        upper Limit
        12
        value
        -21
      6. group Id
        OG006
        lower Limit
        -17
        spread
        -17
        upper Limit
        6
        value
        -15
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      9
    6. group Id
      OG005
      value
      0
    7. group Id
      OG006
      value
      3
    units
    Participants
description
Tumor tissue biopsies were performed at Baseline and on Day 15 3 hours post dose. Levels of pS6RP were quantified using immunohistochemical (IHC) methods.
dispersion Type
Full Range
groups
  1. 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)
  2. 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)
  3. 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)
  4. 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)
  5. 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)
  6. 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)
  7. 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
Up to Cycle 1 Day 15 3 hours post dose
title
Part B: Percent Change From Baseline in pS6RP Levels in Tumor Tissue by Tumor Type
type
SECONDARY
unit Of Measure
Percent change in pS6RP

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Preserved source evidence · Not medical advice