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NCT01212991 · FLOW

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A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer · Source last updated 2020-03-17

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

groups
  1. description
    Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
    id
    FG000
    title
    Enzalutamide
  2. description
    Participants received placebo, administered as four capsules, once per day by mouth.
    id
    FG001
    title
    Placebo
  3. description
    Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
    id
    FG002
    title
    Placebo Participants Crossover to Enzalutamide
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        699
      2. group Id
        FG001
        num Subjects
        550
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    5. reasons
      1. group Id
        FG000
        num Subjects
        142
      2. group Id
        FG001
        num Subjects
        38
      3. group Id
        FG002
        num Subjects
        0
      type
      Sponsor decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        872
      2. group Id
        FG001
        num Subjects
        845
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        871
      2. group Id
        FG001
        num Subjects
        844
      3. group Id
        FG002
        num Subjects
        0
      type
      Safety Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        234
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        872
      2. group Id
        FG001
        num Subjects
        611
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Double-blind
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        166
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        7
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        53
      type
      Sponsor decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        participants were given the opportunity to receive open-label access to enzalutamide
        group Id
        FG001
        num Subjects
        0
      3. comment
        previous placebo treated participants were given the opportunity to receive enzalutamide
        group Id
        FG002
        num Subjects
        234
      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
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        234
      type
      NOT COMPLETED
    title
    Open-label
pre Assignment Details
Following the independent data monitoring committee's recommendation, a protocol amendment was implemented for double-blind phase to be proceeded to open-label phase, which allowed previously placebo treated participants who had not received commercial enzalutamide the opportunity, to receive open-label access to enzalutamide.
Complete source fields
groups
  1. description
    Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
    id
    FG000
    title
    Enzalutamide
  2. description
    Participants received placebo, administered as four capsules, once per day by mouth.
    id
    FG001
    title
    Placebo
  3. description
    Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
    id
    FG002
    title
    Placebo Participants Crossover to Enzalutamide
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        699
      2. group Id
        FG001
        num Subjects
        550
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        19
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    5. reasons
      1. group Id
        FG000
        num Subjects
        142
      2. group Id
        FG001
        num Subjects
        38
      3. group Id
        FG002
        num Subjects
        0
      type
      Sponsor decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        872
      2. group Id
        FG001
        num Subjects
        845
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        871
      2. group Id
        FG001
        num Subjects
        844
      3. group Id
        FG002
        num Subjects
        0
      type
      Safety Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        234
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        872
      2. group Id
        FG001
        num Subjects
        611
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Double-blind
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        166
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        7
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        53
      type
      Sponsor decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        participants were given the opportunity to receive open-label access to enzalutamide
        group Id
        FG001
        num Subjects
        0
      3. comment
        previous placebo treated participants were given the opportunity to receive enzalutamide
        group Id
        FG002
        num Subjects
        234
      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
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        234
      type
      NOT COMPLETED
    title
    Open-label
pre Assignment Details
Following the independent data monitoring committee's recommendation, a protocol amendment was implemented for double-blind phase to be proceeded to open-label phase, which allowed previously placebo treated participants who had not received commercial enzalutamide the opportunity, to receive open-label access to enzalutamide.

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

Preserved source evidence · Not medical advice