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NCT02082977 · BASELINE

Baseline characteristics

A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK2816126 in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma, Transformed Follicular Lymphoma, Other Non-Hodgkin's Lymphomas, Solid Tumors and Multiple Myeloma · Source last updated 2020-02-25

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
      2
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      1
    4. group Id
      BG003
      value
      1
    5. group Id
      BG004
      value
      3
    6. group Id
      BG005
      value
      4
    7. group Id
      BG006
      value
      10
    8. group Id
      BG007
      value
      12
    9. group Id
      BG008
      value
      7
    10. group Id
      BG009
      value
      0
    11. group Id
      BG010
      value
      41
    units
    Participants
groups
  1. description
    Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    BG000
    title
    Part 1:GSK2816126 50 mg Twice-weekly
  2. description
    Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    BG001
    title
    Part 1:GSK2816126 100 mg Twice-weekly
  3. description
    Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    BG002
    title
    Part 1:GSK2816126 200 mg Twice-weekly
  4. description
    Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    BG003
    title
    Part 1:GSK2816126 400 mg Twice-weekly
  5. description
    Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    BG004
    title
    Part 1:GSK2816126 800 mg Twice-weekly
  6. description
    Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    BG005
    title
    Part 1:GSK2816126 1200 mg Twice-weekly
  7. description
    Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    BG006
    title
    Part 1:GSK2816126 1800 mg Twice-weekly
  8. description
    Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    BG007
    title
    Part 1:GSK2816126 2400 mg Twice-weekly
  9. description
    Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    BG008
    title
    Part 1:GSK2816126 3000 mg Twice-weekly
  10. description
    Participants with Germinal Center B-cell-like Diffuse Large B-cell Lymphoma (GCB-DLBCL)-mutant and wild type, Transformed Follicular Lymphoma (TFL)-mutant and wild type as well as with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive recommended Phase II dose (RP2D) .
    id
    BG009
    title
    Part 2: All Participants
  11. description
    Total of all reporting groups
    id
    BG010
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.73
          value
          44.0
        2. comment
          NA indicates data was not available as standard deviation could not be calculated for single participant.
          group Id
          BG001
          spread
          NA
          value
          54.0
        3. comment
          NA indicates data was not available as standard deviation could not be calculated for single participant.
          group Id
          BG002
          spread
          NA
          value
          56.0
        4. comment
          NA indicates data was not available as standard deviation could not be calculated for single participant.
          group Id
          BG003
          spread
          NA
          value
          69.0
        5. group Id
          BG004
          spread
          4.04
          value
          53.3
        6. group Id
          BG005
          spread
          17.18
          value
          49.5
        7. group Id
          BG006
          spread
          14.10
          value
          61.1
        8. group Id
          BG007
          spread
          14.65
          value
          61.9
        9. group Id
          BG008
          spread
          14.30
          value
          58.4
        10. group Id
          BG010
          spread
          13.81
          value
          58.2
    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
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          4
        10. group Id
          BG010
          value
          16
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          3
        10. group Id
          BG010
          value
          25
        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
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG010
          value
          1
        title
        African American/African Heritage
      2. 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
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG010
          value
          1
        title
        Asian-Central/South Asian Heritage
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          12
        9. group Id
          BG008
          value
          5
        10. group Id
          BG010
          value
          37
        title
        White - White/Caucasian/European Heritage
      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
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG010
          value
          1
        title
        Mixed white race
      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
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG010
          value
          1
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Data was not collected in Part 2 of the study as no participant was enrolled in Part 2.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      2
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      1
    4. group Id
      BG003
      value
      1
    5. group Id
      BG004
      value
      3
    6. group Id
      BG005
      value
      4
    7. group Id
      BG006
      value
      10
    8. group Id
      BG007
      value
      12
    9. group Id
      BG008
      value
      7
    10. group Id
      BG009
      value
      0
    11. group Id
      BG010
      value
      41
    units
    Participants
groups
  1. description
    Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    BG000
    title
    Part 1:GSK2816126 50 mg Twice-weekly
  2. description
    Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    BG001
    title
    Part 1:GSK2816126 100 mg Twice-weekly
  3. description
    Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    BG002
    title
    Part 1:GSK2816126 200 mg Twice-weekly
  4. description
    Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    BG003
    title
    Part 1:GSK2816126 400 mg Twice-weekly
  5. description
    Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    BG004
    title
    Part 1:GSK2816126 800 mg Twice-weekly
  6. description
    Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    BG005
    title
    Part 1:GSK2816126 1200 mg Twice-weekly
  7. description
    Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    BG006
    title
    Part 1:GSK2816126 1800 mg Twice-weekly
  8. description
    Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    BG007
    title
    Part 1:GSK2816126 2400 mg Twice-weekly
  9. description
    Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
    id
    BG008
    title
    Part 1:GSK2816126 3000 mg Twice-weekly
  10. description
    Participants with Germinal Center B-cell-like Diffuse Large B-cell Lymphoma (GCB-DLBCL)-mutant and wild type, Transformed Follicular Lymphoma (TFL)-mutant and wild type as well as with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive recommended Phase II dose (RP2D) .
    id
    BG009
    title
    Part 2: All Participants
  11. description
    Total of all reporting groups
    id
    BG010
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.73
          value
          44.0
        2. comment
          NA indicates data was not available as standard deviation could not be calculated for single participant.
          group Id
          BG001
          spread
          NA
          value
          54.0
        3. comment
          NA indicates data was not available as standard deviation could not be calculated for single participant.
          group Id
          BG002
          spread
          NA
          value
          56.0
        4. comment
          NA indicates data was not available as standard deviation could not be calculated for single participant.
          group Id
          BG003
          spread
          NA
          value
          69.0
        5. group Id
          BG004
          spread
          4.04
          value
          53.3
        6. group Id
          BG005
          spread
          17.18
          value
          49.5
        7. group Id
          BG006
          spread
          14.10
          value
          61.1
        8. group Id
          BG007
          spread
          14.65
          value
          61.9
        9. group Id
          BG008
          spread
          14.30
          value
          58.4
        10. group Id
          BG010
          spread
          13.81
          value
          58.2
    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
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          4
        10. group Id
          BG010
          value
          16
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          3
        10. group Id
          BG010
          value
          25
        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
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG010
          value
          1
        title
        African American/African Heritage
      2. 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
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG010
          value
          1
        title
        Asian-Central/South Asian Heritage
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          12
        9. group Id
          BG008
          value
          5
        10. group Id
          BG010
          value
          37
        title
        White - White/Caucasian/European Heritage
      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
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG010
          value
          1
        title
        Mixed white race
      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
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG010
          value
          1
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Data was not collected in Part 2 of the study as no participant was enrolled in Part 2.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice