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NCT02082977 · FLOW

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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.

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
    FG000
    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
    FG001
    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
    FG002
    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
    FG003
    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
    FG004
    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
    FG005
    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
    FG006
    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
    FG007
    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
    FG008
    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
    FG009
    title
    Part 2: All Participants
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Study closed/terminated
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        0
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        10
      8. group Id
        FG007
        num Subjects
        12
      9. group Id
        FG008
        num Subjects
        7
      10. group Id
        FG009
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        7
      9. group Id
        FG008
        num Subjects
        4
      10. group Id
        FG009
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Part 1 (Up to 3.2 Years)
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Part 2 (Up to 3.2 Years)
pre Assignment Details
This study was terminated prior to the completion of Part 1 due to an unfavorable benefit risk profile. Part 2 was not conducted. Approximately 42 participants screened, of which 41 were treated in Part 1 including 20 participants with lymphoma and 21 with solid tumors, of these 22 completed, 5 died and 14 participants were withdrawn.
recruitment Details
This was a 2-part study in participants with relapsed/refractory diffuse large B cell lymphoma, transformed follicular lymphoma, other Non-Hodgkin's lymphomas, solid tumors and multiple myeloma (MM). In Part 1 dose escalation, participants received 50 to 3000 milligrams (mg) of GSK2816126, and Part 2 was dose expansion.
Complete source fields
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
    FG000
    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
    FG001
    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
    FG002
    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
    FG003
    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
    FG004
    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
    FG005
    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
    FG006
    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
    FG007
    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
    FG008
    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
    FG009
    title
    Part 2: All Participants
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Study closed/terminated
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        0
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        10
      8. group Id
        FG007
        num Subjects
        12
      9. group Id
        FG008
        num Subjects
        7
      10. group Id
        FG009
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        7
      9. group Id
        FG008
        num Subjects
        4
      10. group Id
        FG009
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Part 1 (Up to 3.2 Years)
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Part 2 (Up to 3.2 Years)
pre Assignment Details
This study was terminated prior to the completion of Part 1 due to an unfavorable benefit risk profile. Part 2 was not conducted. Approximately 42 participants screened, of which 41 were treated in Part 1 including 20 participants with lymphoma and 21 with solid tumors, of these 22 completed, 5 died and 14 participants were withdrawn.
recruitment Details
This was a 2-part study in participants with relapsed/refractory diffuse large B cell lymphoma, transformed follicular lymphoma, other Non-Hodgkin's lymphomas, solid tumors and multiple myeloma (MM). In Part 1 dose escalation, participants received 50 to 3000 milligrams (mg) of GSK2816126, and Part 2 was dose expansion.

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Preserved source evidence · Not medical advice