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Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer · Source last updated 2023-01-26

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

groups
  1. description
    Participants with DLBCL received Selinexor in different Schedules; Schedule 1: \<= 12 milligram per square meter (mg/m\^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \> 12 mg/m\^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \>=30 mg/m\^2 PO twice weekly (1 day between doses); Schedule 4: \>=23 mg/m\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: \>=40 mg/m\^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: \>=45 mg/m\^2 PO twice weekly in combination with 375 mg/m\^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
    id
    FG000
    title
    Diffuse Large B-cell Lymphoma (DLBCL)
  2. description
    Participants with NHL received Selinexor in different Schedules; Schedule 1: \<= 12 mg/m\^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \> 12 mg/m\^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \>=30 mg/m\^2 PO twice weekly (1 day between doses); Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: \>=45 mg/m\^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \>=40 mg/m\^2 PO twice weekly \[1 Day between doses\] during weeks 1 and 2; Schedule 9: \>=45 mg/m\^2 PO twice weekly in combination with 375 mg/m\^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
    id
    FG001
    title
    Non-Hodgkin Lymphoma (NHL) Excluding DLBCL
  3. description
    Participants with MM received Selinexor in different Schedules; Schedule 1: \<= 12 mg/m\^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: \> 12 mg/m\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m\^2 total) in the 1-week run-in period; Schedule 3: \>=30 mg/m\^2 PO twice weekly (1 day between doses); Schedule 4: \>=23 mg/m\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: \>= 35 mg/m\^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
    id
    FG002
    title
    Multiple Myeloma (MM)
  4. description
    Participants with AML received Selinexor in different Schedules; Schedule 2: \> 12 mg/m\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \>=30 mg/m\^2 PO twice weekly (1 day between doses); Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: \>=45 mg/m\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \>=40 mg/m\^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: \>= 55 mg/m\^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.
    id
    FG003
    title
    Acute Myeloid Leukemia (AML)
  5. description
    Participants with other hematological malignancies (Acute lymphoblastic leukemia \[ALL\], Chronic myelogenous leukemia \[CML\] and chronic lymphocytic leukemia \[CLL\]) received Schedule 2: \> 12 mg/m\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \>=30 mg/m\^2 PO twice weekly \[1 day between doses\]; Schedule 4: \>=23 mg/m\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: \>=45 mg/m\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: \>=45 mg/m\^2 PO twice weekly in combination with 375 mg/m\^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
    id
    FG004
    title
    Other Hematological Malignancies (ALL, CML and CLL)
periods
  1. drop Withdraws
    1. 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
        0
      type
      Need of treatment not allowed per protocol
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        3
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        0
      type
      Investigator discretion
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      type
      Other treatments became available
    5. 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
        3
      5. group Id
        FG004
        num Subjects
        0
      type
      Intercurrent illness
    6. 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
      type
      Non-Compliance with study procedures
    7. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        24
      4. group Id
        FG003
        num Subjects
        14
      5. group Id
        FG004
        num Subjects
        4
      type
      Consent withdrawn by participant
    8. reasons
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        37
      4. group Id
        FG003
        num Subjects
        57
      5. group Id
        FG004
        num Subjects
        9
      type
      Disease progression
    9. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        6
      type
      Incidence or severity of Adverse events
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        58
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        81
      4. group Id
        FG003
        num Subjects
        95
      5. group Id
        FG004
        num Subjects
        24
      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
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        58
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        81
      4. group Id
        FG003
        num Subjects
        95
      5. group Id
        FG004
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 286 participants were enrolled out of which 1 participants with MM never treated due to disease progression prior to dose initiation and 285 participants received treatment in 11 different schedules. The schedules were either 28 days (Schedules 1-7, 9-11) or 21 days (Schedule 8) per cycle and participants were treated once weekly (Schedule 7), twice weekly (Schedules 3-6, 8-11) or three times weekly alternating with 2 times weekly (Schedules 1, 2).
recruitment Details
The study was conducted at 12 sites in United States, Canada and Europe between 23 July 2012 (first participant treated) and 13 October 2015 (last participant completed).
Complete source fields
groups
  1. description
    Participants with DLBCL received Selinexor in different Schedules; Schedule 1: \<= 12 milligram per square meter (mg/m\^2) per orally (PO) alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \> 12 mg/m\^2 PO 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \>=30 mg/m\^2 PO twice weekly (1 day between doses); Schedule 4: \>=23 mg/m\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 8: \>=40 mg/m\^2 PO twice weekly (1 day between doses) during Weeks 1 and 2; Schedule 9: \>=45 mg/m\^2 PO twice weekly in combination with 375 mg/m\^2 dose of rituximab intravenous (IV) once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
    id
    FG000
    title
    Diffuse Large B-cell Lymphoma (DLBCL)
  2. description
    Participants with NHL received Selinexor in different Schedules; Schedule 1: \<= 12 mg/m\^2 PO alternating 3 times per week with twice weekly dosing (1 day between doses); Schedule 2: \> 12 mg/m\^2 PO 3 times weekly for week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \>=30 mg/m\^2 PO twice weekly (1 day between doses); Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs 1 day apart (Schedule 3); Schedule 7: \>=45 mg/m\^2 PO once weekly (6 days between doses) to evaluate vs twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \>=40 mg/m\^2 PO twice weekly \[1 Day between doses\] during weeks 1 and 2; Schedule 9: \>=45 mg/m\^2 PO twice weekly in combination with 375 mg/m\^2 dose of rituximab IV once weekly for Weeks 1-4) during different cycles. Each cycle was of 28 days (Schedule 8: 21 days of cycle) or 10 scheduled selinexor doses.
    id
    FG001
    title
    Non-Hodgkin Lymphoma (NHL) Excluding DLBCL
  3. description
    Participants with MM received Selinexor in different Schedules; Schedule 1: \<= 12 mg/m\^2 PO alternating 3 times per week with twice weekly dosing (1 Day between doses); Schedule 2: \> 12 mg/m\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; 3 doses (36 mg/m\^2 total) in the 1-week run-in period; Schedule 3: \>=30 mg/m\^2 PO twice weekly (1 day between doses); Schedule 4: \>=23 mg/m\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 6: \>= 35 mg/m\^2 PO twice weekly with dexamethasone (20 mg twice weekly) on Days of twice weekly Selinexor dosing; Schedule 11: Group A: 40 mg; Group B: 60 mg; Group C: 80 mg twice weekly (Weeks 1, 2, and 3) at 3 fixed dose levels during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
    id
    FG002
    title
    Multiple Myeloma (MM)
  4. description
    Participants with AML received Selinexor in different Schedules; Schedule 2: \> 12 mg/m\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \>=30 mg/m\^2 PO twice weekly (1 day between doses); Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3), Schedule 7: \>=45 mg/m\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 8: \>=40 mg/m\^2 PO twice weekly (1 Day between doses) during Weeks 1 and 2; Schedule 10: \>= 55 mg/m\^2 PO twice weekly PO (Weeks 1 and 2) in participants with AML/18-Day treatment-free interval) during different cycles. Each cycle was of 28 days (for schedule 8: 21-day of cycle) or 10 scheduled selinexor doses.
    id
    FG003
    title
    Acute Myeloid Leukemia (AML)
  5. description
    Participants with other hematological malignancies (Acute lymphoblastic leukemia \[ALL\], Chronic myelogenous leukemia \[CML\] and chronic lymphocytic leukemia \[CLL\]) received Schedule 2: \> 12 mg/m\^2 3 times weekly for Week -1 followed by same dosing frequency as schedule 1 for Weeks 1-4; Schedule 3: \>=30 mg/m\^2 PO twice weekly \[1 day between doses\]; Schedule 4: \>=23 mg/m\^2 PO twice weekly (0 days between doses) to evaluate consecutive dosing; Schedule 5: \>=30 mg/m\^2 PO twice weekly (2 days between doses) to evaluate dosing 2 days apart vs. 1 day apart (Schedule 3); Schedule 7: \>=45 mg/m\^2 PO once weekly (6 Days between doses) to evaluate vs. twice weekly (Schedules 3, 4, 5, and 6); Schedule 9: \>=45 mg/m\^2 PO twice weekly in combination with 375 mg/m\^2 dose of rituximab IV once weekly for Weeks 1-4 during different cycles. Each cycle was of 28 days or 10 scheduled selinexor doses.
    id
    FG004
    title
    Other Hematological Malignancies (ALL, CML and CLL)
periods
  1. drop Withdraws
    1. 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
        0
      type
      Need of treatment not allowed per protocol
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        3
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        0
      type
      Investigator discretion
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      type
      Other treatments became available
    5. 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
        3
      5. group Id
        FG004
        num Subjects
        0
      type
      Intercurrent illness
    6. 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
      type
      Non-Compliance with study procedures
    7. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        24
      4. group Id
        FG003
        num Subjects
        14
      5. group Id
        FG004
        num Subjects
        4
      type
      Consent withdrawn by participant
    8. reasons
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        37
      4. group Id
        FG003
        num Subjects
        57
      5. group Id
        FG004
        num Subjects
        9
      type
      Disease progression
    9. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        6
      type
      Incidence or severity of Adverse events
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        58
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        81
      4. group Id
        FG003
        num Subjects
        95
      5. group Id
        FG004
        num Subjects
        24
      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
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        58
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        81
      4. group Id
        FG003
        num Subjects
        95
      5. group Id
        FG004
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 286 participants were enrolled out of which 1 participants with MM never treated due to disease progression prior to dose initiation and 285 participants received treatment in 11 different schedules. The schedules were either 28 days (Schedules 1-7, 9-11) or 21 days (Schedule 8) per cycle and participants were treated once weekly (Schedule 7), twice weekly (Schedules 3-6, 8-11) or three times weekly alternating with 2 times weekly (Schedules 1, 2).
recruitment Details
The study was conducted at 12 sites in United States, Canada and Europe between 23 July 2012 (first participant treated) and 13 October 2015 (last participant completed).

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Preserved source evidence · Not medical advice