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NCT01177397 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      1
    2. group Id
      BG001
      value
      2
    3. group Id
      BG002
      value
      9
    4. group Id
      BG003
      value
      9
    5. group Id
      BG004
      value
      7
    6. group Id
      BG005
      value
      26
    7. group Id
      BG006
      value
      13
    8. group Id
      BG007
      value
      53
    9. group Id
      BG008
      value
      47
    10. group Id
      BG009
      value
      28
    11. group Id
      BG010
      value
      14
    12. group Id
      BG011
      value
      17
    units
    Participants
groups
  1. description
    Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 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
    BG000
    title
    Part A: CC-223 7.5 mg
  2. description
    Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 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
    BG001
    title
    Part A: CC-223 15 mg
  3. description
    Participants received a single dose of 30 mg CC-223 on Day -1, then 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
    BG002
    title
    Part A: CC-223 30 mg
  4. description
    Participants received a single dose of 45 mg CC-223 on Day -1, then 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
    BG003
    title
    Part A: CC-223 45 mg
  5. description
    Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 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
    BG004
    title
    Part A: CC-223 60 mg
  6. 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
    BG005
    title
    Part B: Non-small Cell Lung Cancer (NSCLC)
  7. 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
    BG006
    title
    Part B: Glioblastoma Multiforme (GBM)
  8. 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
    BG007
    title
    Part B: Hepatocellular Carcinoma (HCC)
  9. 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
    BG008
    title
    Part B: Neuroendocrine Tumor (NET)
  10. 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
    BG009
    title
    Part B: Diffuse Large B-cell Lymphoma (DLBCL)
  11. 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
    BG010
    title
    Part B: Multiple Myeloma (MM)
  12. 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
    BG011
    title
    Part B: Hormone Receptor Positive Breast Cancer (HRPBC)
measures
  1. classes
    1. categories
      1. measurements
        1. comment
          Standard Deviation not calculable because data were only collected for 1 participant
          group Id
          BG000
          spread
          NA
          value
          55.0
        2. group Id
          BG001
          spread
          10.61
          value
          54.5
        3. group Id
          BG002
          spread
          11.57
          value
          53.8
        4. group Id
          BG003
          spread
          12.86
          value
          46.0
        5. group Id
          BG004
          spread
          11.65
          value
          49.9
        6. group Id
          BG005
          spread
          10.72
          value
          62.8
        7. group Id
          BG006
          spread
          9.46
          value
          55.6
        8. group Id
          BG007
          spread
          11.41
          value
          60.0
        9. group Id
          BG008
          spread
          9.87
          value
          62.6
        10. group Id
          BG009
          spread
          14.51
          value
          53.9
        11. group Id
          BG010
          spread
          10.00
          value
          60.4
        12. group Id
          BG011
          spread
          7.79
          value
          53.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          12
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          28
        10. group Id
          BG009
          value
          11
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          17
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          14
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          43
        9. group Id
          BG008
          value
          19
        10. group Id
          BG009
          value
          17
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          20
        7. group Id
          BG006
          value
          12
        8. group Id
          BG007
          value
          44
        9. group Id
          BG008
          value
          45
        10. group Id
          BG009
          value
          22
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          11
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          5
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          20
        7. group Id
          BG006
          value
          12
        8. group Id
          BG007
          value
          31
        9. group Id
          BG008
          value
          43
        10. group Id
          BG009
          value
          24
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          10
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          5
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race
    unit Of Measure
    Participants
population Description
All treated participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1
    2. group Id
      BG001
      value
      2
    3. group Id
      BG002
      value
      9
    4. group Id
      BG003
      value
      9
    5. group Id
      BG004
      value
      7
    6. group Id
      BG005
      value
      26
    7. group Id
      BG006
      value
      13
    8. group Id
      BG007
      value
      53
    9. group Id
      BG008
      value
      47
    10. group Id
      BG009
      value
      28
    11. group Id
      BG010
      value
      14
    12. group Id
      BG011
      value
      17
    units
    Participants
groups
  1. description
    Participants received a single dose of 7.5 mg CC-223 on Day -1, then daily dosing of 7.5 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
    BG000
    title
    Part A: CC-223 7.5 mg
  2. description
    Participants received a single dose of 15 mg CC-223 on Day -1, then daily dosing of 15 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
    BG001
    title
    Part A: CC-223 15 mg
  3. description
    Participants received a single dose of 30 mg CC-223 on Day -1, then 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
    BG002
    title
    Part A: CC-223 30 mg
  4. description
    Participants received a single dose of 45 mg CC-223 on Day -1, then 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
    BG003
    title
    Part A: CC-223 45 mg
  5. description
    Participants received a single dose of 60 mg CC-223 on Day -1, then daily dosing of 60 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
    BG004
    title
    Part A: CC-223 60 mg
  6. 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
    BG005
    title
    Part B: Non-small Cell Lung Cancer (NSCLC)
  7. 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
    BG006
    title
    Part B: Glioblastoma Multiforme (GBM)
  8. 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
    BG007
    title
    Part B: Hepatocellular Carcinoma (HCC)
  9. 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
    BG008
    title
    Part B: Neuroendocrine Tumor (NET)
  10. 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
    BG009
    title
    Part B: Diffuse Large B-cell Lymphoma (DLBCL)
  11. 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
    BG010
    title
    Part B: Multiple Myeloma (MM)
  12. 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
    BG011
    title
    Part B: Hormone Receptor Positive Breast Cancer (HRPBC)
measures
  1. classes
    1. categories
      1. measurements
        1. comment
          Standard Deviation not calculable because data were only collected for 1 participant
          group Id
          BG000
          spread
          NA
          value
          55.0
        2. group Id
          BG001
          spread
          10.61
          value
          54.5
        3. group Id
          BG002
          spread
          11.57
          value
          53.8
        4. group Id
          BG003
          spread
          12.86
          value
          46.0
        5. group Id
          BG004
          spread
          11.65
          value
          49.9
        6. group Id
          BG005
          spread
          10.72
          value
          62.8
        7. group Id
          BG006
          spread
          9.46
          value
          55.6
        8. group Id
          BG007
          spread
          11.41
          value
          60.0
        9. group Id
          BG008
          spread
          9.87
          value
          62.6
        10. group Id
          BG009
          spread
          14.51
          value
          53.9
        11. group Id
          BG010
          spread
          10.00
          value
          60.4
        12. group Id
          BG011
          spread
          7.79
          value
          53.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          12
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          28
        10. group Id
          BG009
          value
          11
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          17
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          14
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          43
        9. group Id
          BG008
          value
          19
        10. group Id
          BG009
          value
          17
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          20
        7. group Id
          BG006
          value
          12
        8. group Id
          BG007
          value
          44
        9. group Id
          BG008
          value
          45
        10. group Id
          BG009
          value
          22
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          11
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          5
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          20
        7. group Id
          BG006
          value
          12
        8. group Id
          BG007
          value
          31
        9. group Id
          BG008
          value
          43
        10. group Id
          BG009
          value
          24
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          10
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          5
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race
    unit Of Measure
    Participants
population Description
All treated participants

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Preserved source evidence · Not medical advice