Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01136733 · BASELINE

Baseline characteristics

A Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Treatment · Source last updated 2019-02-27

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
      7
    2. group Id
      BG001
      value
      11
    3. group Id
      BG002
      value
      2
    4. group Id
      BG003
      value
      0
    5. group Id
      BG004
      value
      51
    6. group Id
      BG005
      value
      52
    7. group Id
      BG006
      value
      50
    8. group Id
      BG007
      value
      173
    units
    Participants
groups
  1. description
    Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2. If 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped.
    id
    BG000
    title
    Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus
  2. description
    Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3. If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.
    id
    BG001
    title
    Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus
  3. description
    Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment proceeded to Cohort 4. If 1 participant had a DLT, 3 more participants were enrolled Cohort 3. If 1 or none of the 6 participants exhibited a DLT, then enrollment proceeded to Cohort 4. If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.
    id
    BG002
    title
    Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus
  4. description
    The DLT was achieved and no participants were enrolled into this cohort.
    id
    BG003
    title
    Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus
  5. description
    Oral lenvatinib (18 mg) and everolimus (5 mg) was once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.
    id
    BG004
    title
    Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus
  6. description
    Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.
    id
    BG005
    title
    Phase 2 (Arm B): 24 mg Lenvatinib
  7. description
    Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.
    id
    BG006
    title
    Phase 2 (Arm C): 10 mg Everolimus
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.92
          value
          58.0
        2. group Id
          BG001
          spread
          7.97
          value
          58.1
        3. group Id
          BG002
          spread
          2.83
          value
          61.0
        4. group Id
          BG004
          spread
          0
          value
          0
        5. group Id
          BG005
          spread
          0
          value
          0
        6. group Id
          BG006
          spread
          0
          value
          0
        7. group Id
          BG007
          spread
          6.29
          value
          58.4
      title
      Phase 1b
    2. categories
      1. measurements
        1. group Id
          BG000
          spread
          0
          value
          0
        2. group Id
          BG001
          spread
          0
          value
          0
        3. group Id
          BG002
          spread
          0
          value
          0
        4. group Id
          BG004
          spread
          8.2
          value
          61.7
        5. group Id
          BG005
          spread
          8.6
          value
          63.3
        6. group Id
          BG006
          spread
          9.2
          value
          58.9
        7. group Id
          BG007
          spread
          8.8
          value
          61.3
      title
      Phase 2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    GEOMETRIC_MEAN
    title
    Age, Customized
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG004
          value
          16
        5. group Id
          BG005
          value
          13
        6. group Id
          BG006
          value
          12
        7. group Id
          BG007
          value
          47
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          1
        4. group Id
          BG004
          value
          35
        5. group Id
          BG005
          value
          39
        6. group Id
          BG006
          value
          38
        7. group Id
          BG007
          value
          126
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Full analysis set included all randomized participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      7
    2. group Id
      BG001
      value
      11
    3. group Id
      BG002
      value
      2
    4. group Id
      BG003
      value
      0
    5. group Id
      BG004
      value
      51
    6. group Id
      BG005
      value
      52
    7. group Id
      BG006
      value
      50
    8. group Id
      BG007
      value
      173
    units
    Participants
groups
  1. description
    Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2. If 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped.
    id
    BG000
    title
    Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus
  2. description
    Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3. If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.
    id
    BG001
    title
    Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus
  3. description
    Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment proceeded to Cohort 4. If 1 participant had a DLT, 3 more participants were enrolled Cohort 3. If 1 or none of the 6 participants exhibited a DLT, then enrollment proceeded to Cohort 4. If 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.
    id
    BG002
    title
    Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus
  4. description
    The DLT was achieved and no participants were enrolled into this cohort.
    id
    BG003
    title
    Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus
  5. description
    Oral lenvatinib (18 mg) and everolimus (5 mg) was once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.
    id
    BG004
    title
    Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus
  6. description
    Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.
    id
    BG005
    title
    Phase 2 (Arm B): 24 mg Lenvatinib
  7. description
    Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.
    id
    BG006
    title
    Phase 2 (Arm C): 10 mg Everolimus
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.92
          value
          58.0
        2. group Id
          BG001
          spread
          7.97
          value
          58.1
        3. group Id
          BG002
          spread
          2.83
          value
          61.0
        4. group Id
          BG004
          spread
          0
          value
          0
        5. group Id
          BG005
          spread
          0
          value
          0
        6. group Id
          BG006
          spread
          0
          value
          0
        7. group Id
          BG007
          spread
          6.29
          value
          58.4
      title
      Phase 1b
    2. categories
      1. measurements
        1. group Id
          BG000
          spread
          0
          value
          0
        2. group Id
          BG001
          spread
          0
          value
          0
        3. group Id
          BG002
          spread
          0
          value
          0
        4. group Id
          BG004
          spread
          8.2
          value
          61.7
        5. group Id
          BG005
          spread
          8.6
          value
          63.3
        6. group Id
          BG006
          spread
          9.2
          value
          58.9
        7. group Id
          BG007
          spread
          8.8
          value
          61.3
      title
      Phase 2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    GEOMETRIC_MEAN
    title
    Age, Customized
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG004
          value
          16
        5. group Id
          BG005
          value
          13
        6. group Id
          BG006
          value
          12
        7. group Id
          BG007
          value
          47
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          1
        4. group Id
          BG004
          value
          35
        5. group Id
          BG005
          value
          39
        6. group Id
          BG006
          value
          38
        7. group Id
          BG007
          value
          126
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Full analysis set included all randomized participants.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice