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NCT03323034 · BASELINE

Baseline characteristics

Pevonedistat, Irinotecan, and Temozolomide in Treating Patients With Recurrent or Refractory Solid Tumors or Lymphoma · Source last updated 2024-10-22

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
      6
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      30
    units
    Participants
groups
  1. description
    Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Part A Dose Level 1: 15 mg/m^2
  2. description
    Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
    id
    BG001
    title
    Part A Dose Level 2: 20 mg/m^2
  3. description
    Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
    id
    BG002
    title
    Part A Dose Level 3: 25 mg/m^2
  4. description
    Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
    id
    BG003
    title
    Part A Dose Level 4: 35 mg/m^2
  5. description
    Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
    id
    BG004
    title
    Part A PK Dose Level 4: 35 mg/m^2
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          28
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        title
        Between 18 and 65 years
      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
          0
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          6
          upper Limit
          18
          value
          14.5
        2. group Id
          BG001
          lower Limit
          1
          upper Limit
          17
          value
          12
        3. group Id
          BG002
          lower Limit
          2
          upper Limit
          21
          value
          11
        4. group Id
          BG003
          lower Limit
          5
          upper Limit
          15
          value
          7
        5. group Id
          BG004
          lower Limit
          4
          upper Limit
          18
          value
          16.5
        6. group Id
          BG005
          lower Limit
          1
          upper Limit
          21
          value
          13
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          19
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    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
          2
        6. group Id
          BG005
          value
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          24
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        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
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. 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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        title
        Asian
      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
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          18
        title
        White
      6. 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
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      30
    units
    Participants
groups
  1. description
    Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Part A Dose Level 1: 15 mg/m^2
  2. description
    Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
    id
    BG001
    title
    Part A Dose Level 2: 20 mg/m^2
  3. description
    Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
    id
    BG002
    title
    Part A Dose Level 3: 25 mg/m^2
  4. description
    Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
    id
    BG003
    title
    Part A Dose Level 4: 35 mg/m^2
  5. description
    Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, receive pevonedistat IV over 60 minutes on days 1, 8, 10, and 12, temozolomide PO daily on days 8-12, and irinotecan IV over 90 minutes on days 8-12 of cycle 1. Beginning cycle 2, patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, temozolomide PO daily on days 1-5, and irinotecan IV over 90 minutes on days 1-5. Treatment repeats every 28 days for cycle 1 and 21 days for subsequent cycles for up to 17 cycles in the absence of disease progression or unacceptable toxicity.
    id
    BG004
    title
    Part A PK Dose Level 4: 35 mg/m^2
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          28
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        title
        Between 18 and 65 years
      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
          0
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          6
          upper Limit
          18
          value
          14.5
        2. group Id
          BG001
          lower Limit
          1
          upper Limit
          17
          value
          12
        3. group Id
          BG002
          lower Limit
          2
          upper Limit
          21
          value
          11
        4. group Id
          BG003
          lower Limit
          5
          upper Limit
          15
          value
          7
        5. group Id
          BG004
          lower Limit
          4
          upper Limit
          18
          value
          16.5
        6. group Id
          BG005
          lower Limit
          1
          upper Limit
          21
          value
          13
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          19
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    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
          2
        6. group Id
          BG005
          value
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          24
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        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
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. 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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        title
        Asian
      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
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          18
        title
        White
      6. 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
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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