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NCT01327612 · FLOW

Participant flow

Open Label Extension Study of Conatumumab and Ganitumab (AMG 479) · Source last updated 2021-02-21

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

groups
  1. description
    Ganitumab 20 mg/kg once every 4 weeks by intravenous infusion.
    id
    FG000
    title
    20050118: Ganitumab 20 mg/kg
  2. description
    Conatumumab 0.45 mg/kg every 2 weeks by intravenous infusion.
    id
    FG001
    title
    20050171: Conatumumab 0.45 mg/kg
  3. description
    Conatumumab 3 mg/kg every 3 weeks by intravenous infusion.
    id
    FG002
    title
    20060295: Conatumumab 3 mg/kg
  4. description
    Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion.
    id
    FG003
    title
    20060340: Conatumumab 5 mg/kg
  5. description
    Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 (mFOLFOX6) chemotherapy and bevacizumab 5 mg/kg once every 2 weeks.
    id
    FG004
    title
    20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab
  6. description
    Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks.
    id
    FG005
    title
    20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab
  7. description
    Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion.
    id
    FG006
    title
    20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg
periods
  1. drop Withdraws
    1. 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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        2
      type
      Disease Progression
    3. 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
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Administrative Decision
    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
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        2
      type
      STARTED
    2. achievements
      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
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
This was an extension study that permitted participants to continue treatment with conatumumab, with or without co-therapy (modified FOLFOX6 chemotherapy with or without bevacizumab, or ganitumab), or with ganitumab alone, administered at the same dose level and schedule that participants received at the conclusion of the parent study. Participants remained on treatment until disease progression, intolerability, or withdrawal of consent. Results are reported by parent study and treatment.
recruitment Details
This study enrolled participants with different types of solid tumors who had completed one of the following Amgen-sponsored conatumumab or ganitumab studies: 20050118 (NCT00562380) 20050171 20060295 (NCT00534027) 20060340 (NCT00791011) 20060464 (NCT00625651) 20070411 (NCT00819169). Participants who had not progressed in the parent study were eligible to participate in this trial. The study was conducted at 12 centers in the United States, Spain, and Poland.
Complete source fields
groups
  1. description
    Ganitumab 20 mg/kg once every 4 weeks by intravenous infusion.
    id
    FG000
    title
    20050118: Ganitumab 20 mg/kg
  2. description
    Conatumumab 0.45 mg/kg every 2 weeks by intravenous infusion.
    id
    FG001
    title
    20050171: Conatumumab 0.45 mg/kg
  3. description
    Conatumumab 3 mg/kg every 3 weeks by intravenous infusion.
    id
    FG002
    title
    20060295: Conatumumab 3 mg/kg
  4. description
    Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion.
    id
    FG003
    title
    20060340: Conatumumab 5 mg/kg
  5. description
    Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 (mFOLFOX6) chemotherapy and bevacizumab 5 mg/kg once every 2 weeks.
    id
    FG004
    title
    20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab
  6. description
    Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks.
    id
    FG005
    title
    20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab
  7. description
    Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion.
    id
    FG006
    title
    20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg
periods
  1. drop Withdraws
    1. 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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        2
      type
      Disease Progression
    3. 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
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Administrative Decision
    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
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        2
      type
      STARTED
    2. achievements
      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
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
This was an extension study that permitted participants to continue treatment with conatumumab, with or without co-therapy (modified FOLFOX6 chemotherapy with or without bevacizumab, or ganitumab), or with ganitumab alone, administered at the same dose level and schedule that participants received at the conclusion of the parent study. Participants remained on treatment until disease progression, intolerability, or withdrawal of consent. Results are reported by parent study and treatment.
recruitment Details
This study enrolled participants with different types of solid tumors who had completed one of the following Amgen-sponsored conatumumab or ganitumab studies: 20050118 (NCT00562380) 20050171 20060295 (NCT00534027) 20060340 (NCT00791011) 20060464 (NCT00625651) 20070411 (NCT00819169). Participants who had not progressed in the parent study were eligible to participate in this trial. The study was conducted at 12 centers in the United States, Spain, and Poland.

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

Preserved source evidence · Not medical advice