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NCT02669914 · FLOW

Participant flow

MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors · Source last updated 2018-11-06

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

groups
  1. description
    -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
    id
    FG000
    title
    Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids
  2. description
    -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
    id
    FG001
    title
    Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids
  3. description
    -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
    id
    FG002
    title
    Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        4
      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
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The study opened to participant enrollment on 09/12/2016 and closed to participant accrual on 11/16/2017.
Complete source fields
groups
  1. description
    -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
    id
    FG000
    title
    Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids
  2. description
    -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
    id
    FG001
    title
    Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids
  3. description
    -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
    id
    FG002
    title
    Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        4
      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
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The study opened to participant enrollment on 09/12/2016 and closed to participant accrual on 11/16/2017.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice