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NCT02499770 · BASELINE

Baseline characteristics

Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC) · Source last updated 2020-08-21

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
      19
    2. group Id
      BG001
      value
      77
    3. group Id
      BG002
      value
      96
    units
    Participants
groups
  1. description
    The 1st cohort in Part 1 received trilaciclib 200 mg/m\^2, IV once daily on Days 1 to 3 of each 21-day E/P cycle. The 2nd cohort in the Phase 1b dose-finding portion of Part 1 \& the Phase 2a expansion cohort in Part 1 received trilaciclib 240 mg/m\^2, IV once daily on Days 1 to 3 of each 21-day E/P cycle. Participants received standard E/P chemotherapy in 21-day cycles. Carboplatin dose was calculated using the Calvert formula with a target AUC = 5 (maximum 750 mg) IV on Day 1. Etoposide 100 mg/m\^2 was given IV daily on Days 1, 2, \& 3 of each 21-day cycle. Trilaciclib was only given with E/P therapy. If E/P therapy was discontinued, trilaciclib was also to be discontinued. The interval between doses of trilaciclib on successive days was not greater than 28 hours \& between the dose of trilaciclib \& the first dose of chemotherapy on a given day (etoposide or carboplatin) not greater than 4 hours.
    id
    BG000
    title
    Part 1: Dose Finding/Expansion
  2. description
    Eligible participants were randomized (1:1) to trilaciclib or placebo administered IV once daily on Days 1 to 3 of E/P therapy. Randomization was stratified by ECOG performance status (0 to 1 versus 2). Participants received trilaciclib 240 mg/m\^2 (recommended dose from Part 1) or placebo IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle. Participants received standard E/P chemotherapy in 21-day cycles. The carboplatin dose was calculated using the Calvert formula with a target AUC = 5 (maximum 750 mg) IV on Day 1, and 100 mg/m\^2 etoposide was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. The interval between doses of trilaciclib/placebo on successive days was not greater than 28 hours and between the dose of trilaciclib/placebo and the first dose of chemotherapy on a given day (etoposide or carboplatin) was not greater than 4 hours.
    id
    BG001
    title
    Part 2: Trilaciclib/Placebo IV With E/P
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          44
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          52
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          96
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          31
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          65
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          96
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          93
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          96
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        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
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          73
        3. group Id
          BG002
          value
          89
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          96
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          58
        title
        United States
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          38
        title
        Non-United States
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          96
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Country
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.263
          value
          1.90
        2. group Id
          BG001
          spread
          0.216
          value
          1.90
        3. comment
          Mean body surface area was not calculated for all participants overall.
          group Id
          BG002
          spread
          NA
          value
          NA
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          94
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    BSA was only available for 75 of the 77 participants in Part 2.
    title
    Body Surface Area
    unit Of Measure
    m^2
population Description
All participants randomized
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      19
    2. group Id
      BG001
      value
      77
    3. group Id
      BG002
      value
      96
    units
    Participants
groups
  1. description
    The 1st cohort in Part 1 received trilaciclib 200 mg/m\^2, IV once daily on Days 1 to 3 of each 21-day E/P cycle. The 2nd cohort in the Phase 1b dose-finding portion of Part 1 \& the Phase 2a expansion cohort in Part 1 received trilaciclib 240 mg/m\^2, IV once daily on Days 1 to 3 of each 21-day E/P cycle. Participants received standard E/P chemotherapy in 21-day cycles. Carboplatin dose was calculated using the Calvert formula with a target AUC = 5 (maximum 750 mg) IV on Day 1. Etoposide 100 mg/m\^2 was given IV daily on Days 1, 2, \& 3 of each 21-day cycle. Trilaciclib was only given with E/P therapy. If E/P therapy was discontinued, trilaciclib was also to be discontinued. The interval between doses of trilaciclib on successive days was not greater than 28 hours \& between the dose of trilaciclib \& the first dose of chemotherapy on a given day (etoposide or carboplatin) not greater than 4 hours.
    id
    BG000
    title
    Part 1: Dose Finding/Expansion
  2. description
    Eligible participants were randomized (1:1) to trilaciclib or placebo administered IV once daily on Days 1 to 3 of E/P therapy. Randomization was stratified by ECOG performance status (0 to 1 versus 2). Participants received trilaciclib 240 mg/m\^2 (recommended dose from Part 1) or placebo IV once daily on Days 1 to 3 of each 21-day E/P chemotherapy cycle. Participants received standard E/P chemotherapy in 21-day cycles. The carboplatin dose was calculated using the Calvert formula with a target AUC = 5 (maximum 750 mg) IV on Day 1, and 100 mg/m\^2 etoposide was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. The interval between doses of trilaciclib/placebo on successive days was not greater than 28 hours and between the dose of trilaciclib/placebo and the first dose of chemotherapy on a given day (etoposide or carboplatin) was not greater than 4 hours.
    id
    BG001
    title
    Part 2: Trilaciclib/Placebo IV With E/P
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          44
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          52
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          96
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          31
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          65
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          96
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          93
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          96
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        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
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          73
        3. group Id
          BG002
          value
          89
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          96
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          58
        title
        United States
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          38
        title
        Non-United States
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          96
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Country
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.263
          value
          1.90
        2. group Id
          BG001
          spread
          0.216
          value
          1.90
        3. comment
          Mean body surface area was not calculated for all participants overall.
          group Id
          BG002
          spread
          NA
          value
          NA
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          94
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    BSA was only available for 75 of the 77 participants in Part 2.
    title
    Body Surface Area
    unit Of Measure
    m^2
population Description
All participants randomized

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Preserved source evidence · Not medical advice