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NCT02047253 · FLOW

Participant flow

Phase 2 Trial of Carfilzomib for Metastatic Castration-resistant Prostate Cancer Following Treatment · Source last updated 2018-12-19

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

groups
  1. description
    Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient. Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle. Dexamethasone: Administered prior to administration of Study drug Acyclovir: Administered orally twice daily
    id
    FG000
    title
    Carfilzomib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        28
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Protocol Open to Accrual: April 2014, Primary Completion Date: June 2017 and Study Completion Date: July 14, 2017. Recruitment location: University of Alabama at Birmingham (UAB) Comprehensive Cancer Center, Birmingham; Tulane University, New Orleans; Medical Center of Central Georgia, Macon, Georgia, Dana Farber Cancer Institute, Boston.
Complete source fields
groups
  1. description
    Carfilzomib is administered twice-weekly on consecutive days (days 1, 2, 8, 9, 15, 16) as a 30-minute intravenous infusion for 3 weeks every 4 weeks (1 cycle) with dexamethasone given as pre-medication. The dose of carfilzomib is 20 mg/m2 on days 1 and 2 of cycle 1 and is then escalated in succeeding weeks and cycles to 56 mg/m2 if no dose limiting toxicities occur. Acyclovir is given orally at 400 mg twice daily during therapy but may be discontinued at some point. Therapy will continue until side effects become unacceptable, the disease progresses, or the doctor withdraws the patient. Carfilzomib: Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle. Dexamethasone: Administered prior to administration of Study drug Acyclovir: Administered orally twice daily
    id
    FG000
    title
    Carfilzomib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        28
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Protocol Open to Accrual: April 2014, Primary Completion Date: June 2017 and Study Completion Date: July 14, 2017. Recruitment location: University of Alabama at Birmingham (UAB) Comprehensive Cancer Center, Birmingham; Tulane University, New Orleans; Medical Center of Central Georgia, Macon, Georgia, Dana Farber Cancer Institute, Boston.

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Preserved source evidence · Not medical advice