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NCT01064310 · FLOW

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Patient Preference Study of Pazopanib Versus Sunitinib in Advanced or Metastatic Kidney Cancer · Source last updated 2017-04-17

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

groups
  1. description
    Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
    id
    FG000
    title
    Sunitinib 50 mg Followed by Pazopanib 800 mg
  2. description
    Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
    id
    FG001
    title
    Pazopanib 800 mg Followed by Sunitinib 50 mg
  3. description
    To provide continued access to treatment
    id
    FG002
    title
    Open Label Pazopinib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      type
      Lack of Efficacy
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Entered Open-label Period
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        82
      2. group Id
        FG001
        num Subjects
        86
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        68
      2. group Id
        FG001
        num Subjects
        68
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Period 1
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Entered Open-label Period
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      type
      Lack of Efficacy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        68
      2. group Id
        FG001
        num Subjects
        68
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        64
      2. group Id
        FG001
        num Subjects
        62
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Period 2
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        12
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        51
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        20
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        84
      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
        84
      type
      NOT COMPLETED
    title
    Open Label Pazopinib
recruitment Details
There were169 participants randomized and one participant randomized in error with no data available
Complete source fields
groups
  1. description
    Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
    id
    FG000
    title
    Sunitinib 50 mg Followed by Pazopanib 800 mg
  2. description
    Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
    id
    FG001
    title
    Pazopanib 800 mg Followed by Sunitinib 50 mg
  3. description
    To provide continued access to treatment
    id
    FG002
    title
    Open Label Pazopinib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      type
      Lack of Efficacy
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Entered Open-label Period
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        82
      2. group Id
        FG001
        num Subjects
        86
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        68
      2. group Id
        FG001
        num Subjects
        68
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        18
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Period 1
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Entered Open-label Period
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      type
      Lack of Efficacy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        68
      2. group Id
        FG001
        num Subjects
        68
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        64
      2. group Id
        FG001
        num Subjects
        62
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Period 2
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        12
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        51
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        20
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        84
      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
        84
      type
      NOT COMPLETED
    title
    Open Label Pazopinib
recruitment Details
There were169 participants randomized and one participant randomized in error with no data available

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Preserved source evidence · Not medical advice