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NCT03395197 · BASELINE

Baseline characteristics

Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC · Source last updated 2026-09-08

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
      13
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      402
    4. group Id
      BG003
      value
      403
    5. group Id
      BG004
      value
      115
    6. group Id
      BG005
      value
      115
    7. group Id
      BG006
      value
      1054
    units
    Participants
groups
  1. description
    Participants initially received a starting dose of talazoparib 1 mg once daily (QD) in combination with enzalutamide 160 mg QD up until Day 66, then the dose of talazoparib was reduced to 0.5 mg QD based on results from a review of available safety and pharmacokinetic (PK) data (up to a maximum of 231.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
    id
    BG000
    title
    Part 1: Talazoparib 1 mg QD+Enzalutamide
  2. description
    Participants received talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 180 weeks for talazoparib and 219.29 weeks for enzalutamide as of 16 Aug 2022).
    id
    BG001
    title
    Part 1: Talazoparib 0.5 mg QD+Enzalutamide
  3. description
    Participants were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 186.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
    id
    BG002
    title
    Part 2 Cohort 1: Talazoparib+Enzalutamide (All-comer)
  4. description
    Participants were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 182 weeks for both placebo and enzalutamide as of 16 Aug 2022).
    id
    BG003
    title
    Part 2 Cohort 1: Placebo+Enzalutamide (All-comer)
  5. description
    Participants with DDR deficiencies were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 169.86 weeks for both talazoparib and enzalutamide as of 03 Oct 2022).
    id
    BG004
    title
    Part 2 Cohort 2: Talazoparib+Enzalutamide (DDR-deficient)
  6. description
    Participants with DDR deficiencies were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 157 weeks for both placebo and enzalutamide as of 03 Oct 2022).
    id
    BG005
    title
    Part 2 Cohort 2: Placebo+Enzalutamide (DDR-deficient)
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          79
        4. group Id
          BG003
          value
          94
        5. group Id
          BG004
          value
          25
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          227
        title
        <65 years
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          188
        4. group Id
          BG003
          value
          175
        5. group Id
          BG004
          value
          53
        6. group Id
          BG005
          value
          55
        7. group Id
          BG006
          value
          483
        title
        65-<75 years
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          135
        4. group Id
          BG003
          value
          134
        5. group Id
          BG004
          value
          37
        6. group Id
          BG005
          value
          34
        7. group Id
          BG006
          value
          344
        title
        >=75 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. 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
        7. group Id
          BG006
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          402
        4. group Id
          BG003
          value
          403
        5. group Id
          BG004
          value
          115
        6. group Id
          BG005
          value
          115
        7. group Id
          BG006
          value
          1054
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          243
        4. group Id
          BG003
          value
          255
        5. group Id
          BG004
          value
          88
        6. group Id
          BG005
          value
          90
        7. group Id
          BG006
          value
          694
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          23
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          127
        4. group Id
          BG003
          value
          120
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          12
        7. group Id
          BG006
          value
          272
        title
        Asian
      4. 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
          0
        7. group Id
          BG006
          value
          1
        title
        American Indian or Alaska Native
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          4
        title
        Native Hawaiian or Other Pacific Islander
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          58
        title
        Not Reported
      7. 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
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        title
        Unknown
      8. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        title
        Multiracial
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Included all participants who received at least 1 dose of study treatment (talazoparib or enzalutamide) in Part 1, and all participants who were randomized to double-blind study treatment in Part 2 regardless of whether or not treatment was administered.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      13
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      402
    4. group Id
      BG003
      value
      403
    5. group Id
      BG004
      value
      115
    6. group Id
      BG005
      value
      115
    7. group Id
      BG006
      value
      1054
    units
    Participants
groups
  1. description
    Participants initially received a starting dose of talazoparib 1 mg once daily (QD) in combination with enzalutamide 160 mg QD up until Day 66, then the dose of talazoparib was reduced to 0.5 mg QD based on results from a review of available safety and pharmacokinetic (PK) data (up to a maximum of 231.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
    id
    BG000
    title
    Part 1: Talazoparib 1 mg QD+Enzalutamide
  2. description
    Participants received talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 180 weeks for talazoparib and 219.29 weeks for enzalutamide as of 16 Aug 2022).
    id
    BG001
    title
    Part 1: Talazoparib 0.5 mg QD+Enzalutamide
  3. description
    Participants were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 186.14 weeks for both talazoparib and enzalutamide as of 16 Aug 2022).
    id
    BG002
    title
    Part 2 Cohort 1: Talazoparib+Enzalutamide (All-comer)
  4. description
    Participants were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 182 weeks for both placebo and enzalutamide as of 16 Aug 2022).
    id
    BG003
    title
    Part 2 Cohort 1: Placebo+Enzalutamide (All-comer)
  5. description
    Participants with DDR deficiencies were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 169.86 weeks for both talazoparib and enzalutamide as of 03 Oct 2022).
    id
    BG004
    title
    Part 2 Cohort 2: Talazoparib+Enzalutamide (DDR-deficient)
  6. description
    Participants with DDR deficiencies were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 157 weeks for both placebo and enzalutamide as of 03 Oct 2022).
    id
    BG005
    title
    Part 2 Cohort 2: Placebo+Enzalutamide (DDR-deficient)
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          79
        4. group Id
          BG003
          value
          94
        5. group Id
          BG004
          value
          25
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          227
        title
        <65 years
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          188
        4. group Id
          BG003
          value
          175
        5. group Id
          BG004
          value
          53
        6. group Id
          BG005
          value
          55
        7. group Id
          BG006
          value
          483
        title
        65-<75 years
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          135
        4. group Id
          BG003
          value
          134
        5. group Id
          BG004
          value
          37
        6. group Id
          BG005
          value
          34
        7. group Id
          BG006
          value
          344
        title
        >=75 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. 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
        7. group Id
          BG006
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          402
        4. group Id
          BG003
          value
          403
        5. group Id
          BG004
          value
          115
        6. group Id
          BG005
          value
          115
        7. group Id
          BG006
          value
          1054
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          243
        4. group Id
          BG003
          value
          255
        5. group Id
          BG004
          value
          88
        6. group Id
          BG005
          value
          90
        7. group Id
          BG006
          value
          694
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          23
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          127
        4. group Id
          BG003
          value
          120
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          12
        7. group Id
          BG006
          value
          272
        title
        Asian
      4. 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
          0
        7. group Id
          BG006
          value
          1
        title
        American Indian or Alaska Native
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          4
        title
        Native Hawaiian or Other Pacific Islander
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          58
        title
        Not Reported
      7. 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
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        title
        Unknown
      8. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        title
        Multiracial
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Included all participants who received at least 1 dose of study treatment (talazoparib or enzalutamide) in Part 1, and all participants who were randomized to double-blind study treatment in Part 2 regardless of whether or not treatment was administered.

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Preserved source evidence · Not medical advice