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NCT01177397 · OUTCOME

Part B: Overall Response Rate

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From first dose up to tumor response (approximately 36 months)

What was measured

Tumor response was based on Investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors (NSCLC, HCC, NET, and HRPBC), International Working Group Criteria (IWC) for DLBCL, and the International Myeloma Working Group (IMWG) criteria for MM. For GBM, Responses Assessment for Neuro-Oncology Working Group (RANO) criteria were used for tumor response, using the post resection MRI scan as the baseline. Overall Response Rate is defined as the percentage of participants with a best overall response of complete response or partial response. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Analysis population: Participants who received treatment in Part B reported by tumor cohort

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)26
Part B: Glioblastoma Multiforme (GBM)13
Part B: Hepatocellular Carcinoma (HCC)53
Part B: Neuroendocrine Tumor (NET)47
Part B: Diffuse Large B-cell Lymphoma (DLBCL)28
Part B: Multiple Myeloma (MM)14
Part B: Hormone Receptor Positive Breast Cancer (HRPBC)17

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part B: Non-small Cell Lung Cancer (NSCLC)3.8Not reported0.119.6Not reported
Part B: Glioblastoma Multiforme (GBM)0Not reportedNANALower and upper limit not calculated due to insufficient number of events
Part B: Hepatocellular Carcinoma (HCC)5.7Not reported1.215.7Not reported
Part B: Neuroendocrine Tumor (NET)6.4Not reported1.317.5Not reported
Part B: Diffuse Large B-cell Lymphoma (DLBCL)10.7Not reported2.328.2Not reported
Part B: Multiple Myeloma (MM)0Not reportedNANALower and upper limit not calculated due to insufficient number of events
Part B: Hormone Receptor Positive Breast Cancer (HRPBC)11.8Not reported1.536.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.1
        upper Limit
        19.6
        value
        3.8
      2. comment
        Lower and upper limit not calculated due to insufficient number of events
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        0
      3. group Id
        OG002
        lower Limit
        1.2
        upper Limit
        15.7
        value
        5.7
      4. group Id
        OG003
        lower Limit
        1.3
        upper Limit
        17.5
        value
        6.4
      5. group Id
        OG004
        lower Limit
        2.3
        upper Limit
        28.2
        value
        10.7
      6. comment
        Lower and upper limit not calculated due to insufficient number of events
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        0
      7. group Id
        OG006
        lower Limit
        1.5
        upper Limit
        36.4
        value
        11.8
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    2. group Id
      OG001
      value
      13
    3. group Id
      OG002
      value
      53
    4. group Id
      OG003
      value
      47
    5. group Id
      OG004
      value
      28
    6. group Id
      OG005
      value
      14
    7. group Id
      OG006
      value
      17
    units
    Participants
description
Tumor response was based on Investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors (NSCLC, HCC, NET, and HRPBC), International Working Group Criteria (IWC) for DLBCL, and the International Myeloma Working Group (IMWG) criteria for MM. For GBM, Responses Assessment for Neuro-Oncology Working Group (RANO) criteria were used for tumor response, using the post resection MRI scan as the baseline. Overall Response Rate is defined as the percentage of participants with a best overall response of complete response or partial response. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
dispersion Type
95% Confidence Interval
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
NUMBER
population Description
Participants who received treatment in Part B reported by tumor cohort
reporting Status
POSTED
time Frame
From first dose up to tumor response (approximately 36 months)
title
Part B: Overall Response Rate
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice