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NCT01713582 · FLOW

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A Dose-finding Study of the Bromodomain (Brd) Inhibitor OTX015/ Birabresib (MK-8628) in Hematologic Malignancies (MK-8628-001) · Source last updated 2021-01-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    FG000
    title
    AL 10 mg QD 14-21
  2. description
    Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    FG001
    title
    AL 20 mg QD 14-21
  3. description
    Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    FG002
    title
    AL 40 mg QD 14-21
  4. description
    Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
    id
    FG003
    title
    AL 20 mg BID 21-21
  5. description
    Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    FG004
    title
    AL 80 mg QD 14-21
  6. description
    Participants received 40 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
    id
    FG005
    title
    AL 40 mg BID 14-21
  7. description
    Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    FG006
    title
    AL 120 mg QD 14-21
  8. description
    Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
    id
    FG007
    title
    AL 120 mg QD 21-21
  9. description
    Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    FG008
    title
    AL 160 mg QD 14-21
  10. description
    Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    FG009
    title
    AML de Novo 80 mg QD 14-21
  11. description
    Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    FG010
    title
    AML/MDS 80 mg QD 14-21
  12. description
    Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
    id
    FG011
    title
    OHM 10 mg QD 21-21
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        11
      11. group Id
        FG010
        num Subjects
        10
      12. group Id
        FG011
        num Subjects
        5
      type
      Disease progression
    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
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        4
      11. group Id
        FG010
        num Subjects
        3
      12. group Id
        FG011
        num Subjects
        0
      type
      Death
    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
        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
        1
      11. group Id
        FG010
        num Subjects
        1
      12. group Id
        FG011
        num Subjects
        0
      type
      Adverse event-related
    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
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Adverse event-unrelated
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      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
        1
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Withdrawal of consent
    6. 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
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        2
      12. group Id
        FG011
        num Subjects
        0
      type
      Lack of Efficacy
    7. 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
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Withdrawal by Subject
    8. 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
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Stopped to receive bone marrow graft
    9. 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
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Disease progression and adverse event
    milestones
    1. achievements
      1. comment
        Number treated
        group Id
        FG000
        num Subjects
        3
      2. comment
        Number treated
        group Id
        FG001
        num Subjects
        3
      3. comment
        Number treated
        group Id
        FG002
        num Subjects
        4
      4. comment
        Number treated
        group Id
        FG003
        num Subjects
        3
      5. comment
        Number treated
        group Id
        FG004
        num Subjects
        4
      6. comment
        Number treated
        group Id
        FG005
        num Subjects
        8
      7. comment
        Number treated
        group Id
        FG006
        num Subjects
        7
      8. comment
        Number treated
        group Id
        FG007
        num Subjects
        6
      9. comment
        Number treated
        group Id
        FG008
        num Subjects
        6
      10. comment
        Number treated
        group Id
        FG009
        num Subjects
        18
      11. comment
        Number treated
        group Id
        FG010
        num Subjects
        16
      12. comment
        Number treated
        group Id
        FG011
        num Subjects
        5
      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
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        7
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        18
      11. group Id
        FG010
        num Subjects
        16
      12. group Id
        FG011
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study consisted of a dose escalation phase in participants with AL and OHM followed by and expansion phase in 3 cohorts: de novo acute myelocytic leukemia (AML), myelodysplastic syndrome (MDS) AML, and diffuse large B-cell lymphoma (DLBCL).
recruitment Details
80 participants were enrolled in the acute leukemia (AL) cohort and 78 were treated. 61 participants were enrolled in the other hematological malignancies (OHM) cohort and 60 were treated.
Complete source fields
groups
  1. description
    Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    FG000
    title
    AL 10 mg QD 14-21
  2. description
    Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    FG001
    title
    AL 20 mg QD 14-21
  3. description
    Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    FG002
    title
    AL 40 mg QD 14-21
  4. description
    Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
    id
    FG003
    title
    AL 20 mg BID 21-21
  5. description
    Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    FG004
    title
    AL 80 mg QD 14-21
  6. description
    Participants received 40 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
    id
    FG005
    title
    AL 40 mg BID 14-21
  7. description
    Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    FG006
    title
    AL 120 mg QD 14-21
  8. description
    Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
    id
    FG007
    title
    AL 120 mg QD 21-21
  9. description
    Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    FG008
    title
    AL 160 mg QD 14-21
  10. description
    Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    FG009
    title
    AML de Novo 80 mg QD 14-21
  11. description
    Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    FG010
    title
    AML/MDS 80 mg QD 14-21
  12. description
    Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
    id
    FG011
    title
    OHM 10 mg QD 21-21
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        11
      11. group Id
        FG010
        num Subjects
        10
      12. group Id
        FG011
        num Subjects
        5
      type
      Disease progression
    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
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        4
      11. group Id
        FG010
        num Subjects
        3
      12. group Id
        FG011
        num Subjects
        0
      type
      Death
    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
        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
        1
      11. group Id
        FG010
        num Subjects
        1
      12. group Id
        FG011
        num Subjects
        0
      type
      Adverse event-related
    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
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Adverse event-unrelated
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      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
        1
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Withdrawal of consent
    6. 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
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        2
      12. group Id
        FG011
        num Subjects
        0
      type
      Lack of Efficacy
    7. 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
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Withdrawal by Subject
    8. 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
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Stopped to receive bone marrow graft
    9. 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
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Disease progression and adverse event
    milestones
    1. achievements
      1. comment
        Number treated
        group Id
        FG000
        num Subjects
        3
      2. comment
        Number treated
        group Id
        FG001
        num Subjects
        3
      3. comment
        Number treated
        group Id
        FG002
        num Subjects
        4
      4. comment
        Number treated
        group Id
        FG003
        num Subjects
        3
      5. comment
        Number treated
        group Id
        FG004
        num Subjects
        4
      6. comment
        Number treated
        group Id
        FG005
        num Subjects
        8
      7. comment
        Number treated
        group Id
        FG006
        num Subjects
        7
      8. comment
        Number treated
        group Id
        FG007
        num Subjects
        6
      9. comment
        Number treated
        group Id
        FG008
        num Subjects
        6
      10. comment
        Number treated
        group Id
        FG009
        num Subjects
        18
      11. comment
        Number treated
        group Id
        FG010
        num Subjects
        16
      12. comment
        Number treated
        group Id
        FG011
        num Subjects
        5
      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
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        7
      8. group Id
        FG007
        num Subjects
        6
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        18
      11. group Id
        FG010
        num Subjects
        16
      12. group Id
        FG011
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study consisted of a dose escalation phase in participants with AL and OHM followed by and expansion phase in 3 cohorts: de novo acute myelocytic leukemia (AML), myelodysplastic syndrome (MDS) AML, and diffuse large B-cell lymphoma (DLBCL).
recruitment Details
80 participants were enrolled in the acute leukemia (AL) cohort and 78 were treated. 61 participants were enrolled in the other hematological malignancies (OHM) cohort and 60 were treated.

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