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NCT00410124 · FLOW

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RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed After Treatment With Sorafenib and/or Sunitinib · Source last updated 2013-01-15

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

groups
  1. description
    The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    id
    FG000
    title
    RAD001 +BSC
  2. description
    Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    id
    FG001
    title
    Placebo + BSC / RAD001
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        2
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Abnormal Laboratory Value
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Administrative Problems
    7. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      type
      Death
    8. reasons
      1. group Id
        FG000
        num Subjects
        137
      2. group Id
        FG001
        num Subjects
        124
      type
      Disease Progression
    milestones
    1. achievements
      1. comment
        Started indicates randomized (FAS) and treated
        group Id
        FG000
        num Subjects
        277
      2. group Id
        FG001
        num Subjects
        139
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        4
      type
      Ongoing
    3. achievements
      1. group Id
        FG000
        num Subjects
        62
      2. group Id
        FG001
        num Subjects
        2
      type
      Completed Double Blind Treatment
    4. achievements
      1. comment
        Patients ongoing/completed double blind phase had option entering extension phase continuing RAD001.
        group Id
        FG000
        num Subjects
        75
      2. comment
        All patients ongoing/completed/not completed in core had option to enter extension taking RAD001.
        group Id
        FG001
        num Subjects
        6
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        202
      2. group Id
        FG001
        num Subjects
        133
      type
      NOT COMPLETED
    title
    Core Phase Double Blind (15 Months)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        19
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Abnormal Laboratory Values
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Abnormal Test Procedures
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        10
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        56
      2. group Id
        FG001
        num Subjects
        78
      type
      Disease Progression
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Patient no longer required study drug
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Final Primary Analysis
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        67
      2. comment
        Patients on placebo in core received RAD001 in extension phase.
        group Id
        FG001
        num Subjects
        111
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        67
      2. group Id
        FG001
        num Subjects
        111
      type
      NOT COMPLETED
    title
    Extension Phase - Open Label (45 Months)
pre Assignment Details
Core period was terminated due to early achievements of efficacy targets and patients who were receiving study drug and patients receiving placebo in double blind phase had option to continue into the extension phase to receive open label RAD001.
Complete source fields
groups
  1. description
    The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    id
    FG000
    title
    RAD001 +BSC
  2. description
    Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
    id
    FG001
    title
    Placebo + BSC / RAD001
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        2
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Abnormal Laboratory Value
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Administrative Problems
    7. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      type
      Death
    8. reasons
      1. group Id
        FG000
        num Subjects
        137
      2. group Id
        FG001
        num Subjects
        124
      type
      Disease Progression
    milestones
    1. achievements
      1. comment
        Started indicates randomized (FAS) and treated
        group Id
        FG000
        num Subjects
        277
      2. group Id
        FG001
        num Subjects
        139
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        4
      type
      Ongoing
    3. achievements
      1. group Id
        FG000
        num Subjects
        62
      2. group Id
        FG001
        num Subjects
        2
      type
      Completed Double Blind Treatment
    4. achievements
      1. comment
        Patients ongoing/completed double blind phase had option entering extension phase continuing RAD001.
        group Id
        FG000
        num Subjects
        75
      2. comment
        All patients ongoing/completed/not completed in core had option to enter extension taking RAD001.
        group Id
        FG001
        num Subjects
        6
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        202
      2. group Id
        FG001
        num Subjects
        133
      type
      NOT COMPLETED
    title
    Core Phase Double Blind (15 Months)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        19
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Abnormal Laboratory Values
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Abnormal Test Procedures
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        10
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        56
      2. group Id
        FG001
        num Subjects
        78
      type
      Disease Progression
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Patient no longer required study drug
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Final Primary Analysis
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        67
      2. comment
        Patients on placebo in core received RAD001 in extension phase.
        group Id
        FG001
        num Subjects
        111
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        67
      2. group Id
        FG001
        num Subjects
        111
      type
      NOT COMPLETED
    title
    Extension Phase - Open Label (45 Months)
pre Assignment Details
Core period was terminated due to early achievements of efficacy targets and patients who were receiving study drug and patients receiving placebo in double blind phase had option to continue into the extension phase to receive open label RAD001.

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Preserved source evidence · Not medical advice