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NCT01096342 · FLOW

Participant flow

Dinaciclib in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2014-06-18

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

groups
  1. description
    Participants were accrued at 50 mg/m\^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m\^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Phase II: 50 mg/m^2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Protocol Violation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        15
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of the 10 participants accrued in the Phase II portion of the study, one was excluded for protocol violation. The 6 participants treated in the Safety Analysis Phase at the 50 mg/m\^2 dose level (after the protocol amendment) are included in the Phase II analysis. Therefore, this Phase II analysis is based on 15 evaluable participants.
recruitment Details
From 7/2009 to 12/2011, 29 participants were accrued. The study opened at 50 mg/m\^2, accrued 2, and closed for safety review and protocol amendment. The study reopened with a dose escalation phase and accrued 4 at 30 mg/m\^2 dose, 7 at 40 mg/m\^2 dose, and 6 at 50 mg/m\^2 dose. The Phase II dose level was set at 50 mg/m\^2 and accrued 10 participants.
Complete source fields
groups
  1. description
    Participants were accrued at 50 mg/m\^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m\^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Phase II: 50 mg/m^2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Protocol Violation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        15
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of the 10 participants accrued in the Phase II portion of the study, one was excluded for protocol violation. The 6 participants treated in the Safety Analysis Phase at the 50 mg/m\^2 dose level (after the protocol amendment) are included in the Phase II analysis. Therefore, this Phase II analysis is based on 15 evaluable participants.
recruitment Details
From 7/2009 to 12/2011, 29 participants were accrued. The study opened at 50 mg/m\^2, accrued 2, and closed for safety review and protocol amendment. The study reopened with a dose escalation phase and accrued 4 at 30 mg/m\^2 dose, 7 at 40 mg/m\^2 dose, and 6 at 50 mg/m\^2 dose. The Phase II dose level was set at 50 mg/m\^2 and accrued 10 participants.

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Preserved source evidence · Not medical advice