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NCT00920556 · FLOW

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A Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination With Bortezomib in Patients With Multiple Myeloma · Source last updated 2019-02-27

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

groups
  1. description
    Eligible participants were administered 5 gram (g) of SRT501, as oral suspension every morning approximately 15-30 minutes after breakfast), for 20 days in 21-day cycle, for max period of 12 cycles (Not administered on Day 21 of each cycle). Post first two cycles, participant who exhibited stable disease (SD) or better, with SRT501 monotherapy, continued for additional two cycles. If, after first 2 cycles, participant exhibited PD, then received bortezomib (1.3 milligram(mg)/meter square (m\^2)on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) along with SRT501. Bortezomib was administered intravenous suspension, prior to breakfast and SRT501 administration. If after 2 additional cycles of SRT501 monotherapy (4 cycles total), participant exhibited SD or better, they remained on SRT501 therapy, until judged to have PD. If PD,participants underwent bortezomib regiment as above. At any point of (SRT501+Bortezoimb),participant was assessed with PD, was discontinued
    id
    FG000
    title
    Overall Study
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        16
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
A total of 24 participants with Multiple Myeloma were enrolled in the study. The study was conducted at four centers in United Kingdom and 1 center in Denmark, and was terminated early.
Complete source fields
groups
  1. description
    Eligible participants were administered 5 gram (g) of SRT501, as oral suspension every morning approximately 15-30 minutes after breakfast), for 20 days in 21-day cycle, for max period of 12 cycles (Not administered on Day 21 of each cycle). Post first two cycles, participant who exhibited stable disease (SD) or better, with SRT501 monotherapy, continued for additional two cycles. If, after first 2 cycles, participant exhibited PD, then received bortezomib (1.3 milligram(mg)/meter square (m\^2)on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) along with SRT501. Bortezomib was administered intravenous suspension, prior to breakfast and SRT501 administration. If after 2 additional cycles of SRT501 monotherapy (4 cycles total), participant exhibited SD or better, they remained on SRT501 therapy, until judged to have PD. If PD,participants underwent bortezomib regiment as above. At any point of (SRT501+Bortezoimb),participant was assessed with PD, was discontinued
    id
    FG000
    title
    Overall Study
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        16
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
A total of 24 participants with Multiple Myeloma were enrolled in the study. The study was conducted at four centers in United Kingdom and 1 center in Denmark, and was terminated early.

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Preserved source evidence · Not medical advice