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NCT02609828 · FLOW

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Phase 3 Study on the Efficacy and Safety of Tanezumab in Patients With Cancer Pain Due to Bone Metastasis Who Are Taking Background Opioid Therapy · Source last updated 2023-02-16

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

groups
  1. description
    Participants received placebo matched to tanezumab subcutaneous (SC) once every 8 weeks for 24 weeks.
    id
    FG000
    title
    Placebo
  2. description
    Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment.
    id
    FG001
    title
    Tanezumab 10 mg
  3. description
    Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks.
    id
    FG002
    title
    Tanezumab 10/20 mg
  4. description
    Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks.
    id
    FG003
    title
    Tanezumab 20 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        6
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        19
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Insufficient clinical response
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Protocol Violation
    6. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        10
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        6
      type
      Other
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Randomized but not treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        74
      2. comment
        A total of 10 participants were initially randomized to this arm. This arm was discontinued per protocol amendment 3. At time of amendment, out of 10 participants, 1 participant was still in treatment with tanezumab 10 mg. Post-amendment, this participant continued treatment with tanezumab 20 mg and was included in tanezumab 10/20 mg arm.
        group Id
        FG001
        num Subjects
        9
      3. comment
        The participant switched to this arm from tanezumab 10 mg post protocol amendment 3 implementation for remaining doses.
        group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        72
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        73
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        72
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        29
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        43
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Total 325 participants signed the inform consent form (ICF). Out of which 158 participants were screen failures, and 11 participants were screened but not enrolled and randomized into the study. Total of 156 participants were enrolled and randomized into the study and assigned to study treatments.
recruitment Details
Participants with cancer pain predominantly due to bone metastasis and receiving background opioid therapy, were randomized into 3 treatment arms: tanezumab 20 milligrams (mg), tanezumab 10 mg and placebo. After study start, tanezumab 10 mg arm was discontinued in protocol amendment 3: no new participants were enrolled into the arm. Existing participants in the arm received tanezumab 20 mg for any remaining doses and were included in tanezumab 10/20 mg arm.
Complete source fields
groups
  1. description
    Participants received placebo matched to tanezumab subcutaneous (SC) once every 8 weeks for 24 weeks.
    id
    FG000
    title
    Placebo
  2. description
    Participants in this discontinued treatment arm, received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and completed their treatment before the amendment.
    id
    FG001
    title
    Tanezumab 10 mg
  3. description
    Participants in this treatment group had received tanezumab 10 mg SC once every 8 weeks before protocol amendment 3 and after the amendment they continued remaining treatment with tanezumab 20 mg SC once every 8 weeks.
    id
    FG002
    title
    Tanezumab 10/20 mg
  4. description
    Participants received tanezumab 20 mg SC once every 8 weeks for 24 weeks.
    id
    FG003
    title
    Tanezumab 20 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        6
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        19
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Insufficient clinical response
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Protocol Violation
    6. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        10
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        6
      type
      Other
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Randomized but not treated
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        74
      2. comment
        A total of 10 participants were initially randomized to this arm. This arm was discontinued per protocol amendment 3. At time of amendment, out of 10 participants, 1 participant was still in treatment with tanezumab 10 mg. Post-amendment, this participant continued treatment with tanezumab 20 mg and was included in tanezumab 10/20 mg arm.
        group Id
        FG001
        num Subjects
        9
      3. comment
        The participant switched to this arm from tanezumab 10 mg post protocol amendment 3 implementation for remaining doses.
        group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        72
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        73
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        72
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        31
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        29
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        43
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Total 325 participants signed the inform consent form (ICF). Out of which 158 participants were screen failures, and 11 participants were screened but not enrolled and randomized into the study. Total of 156 participants were enrolled and randomized into the study and assigned to study treatments.
recruitment Details
Participants with cancer pain predominantly due to bone metastasis and receiving background opioid therapy, were randomized into 3 treatment arms: tanezumab 20 milligrams (mg), tanezumab 10 mg and placebo. After study start, tanezumab 10 mg arm was discontinued in protocol amendment 3: no new participants were enrolled into the arm. Existing participants in the arm received tanezumab 20 mg for any remaining doses and were included in tanezumab 10/20 mg arm.

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Preserved source evidence · Not medical advice