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NCT00701103 · FLOW

Participant flow

Dose Escalation Trial of Dalotuzumab (MK-0646) in Advanced Solid Tumors and Multiple Myeloma (MK-0646-001) · Source last updated 2018-08-08

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

groups
  1. description
    Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) intravenous (IV) infusion 1 time every 1 week (Q1W).
    id
    FG000
    title
    Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
  2. description
    Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
    id
    FG001
    title
    Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
  3. description
    Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
    id
    FG002
    title
    Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
  4. description
    Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
    id
    FG003
    title
    Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
  5. description
    Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
    id
    FG004
    title
    Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
  6. description
    Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
    id
    FG005
    title
    Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
  7. description
    Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
    id
    FG006
    title
    Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
  8. description
    Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
    id
    FG007
    title
    Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
  9. description
    Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
    id
    FG008
    title
    Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
  10. description
    Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion 1 time every 2 weeks (Q2W).
    id
    FG009
    title
    Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
  11. description
    Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion 1 time every 3 weeks (Q3W).
    id
    FG010
    title
    Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
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
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        2
      11. group Id
        FG010
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        7
      8. group Id
        FG007
        num Subjects
        7
      9. group Id
        FG008
        num Subjects
        8
      10. group Id
        FG009
        num Subjects
        8
      11. group Id
        FG010
        num Subjects
        11
      type
      Progressive Disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      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
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Withdrawal by Subject
    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
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        8
      8. group Id
        FG007
        num Subjects
        7
      9. group Id
        FG008
        num Subjects
        9
      10. group Id
        FG009
        num Subjects
        11
      11. group Id
        FG010
        num Subjects
        11
      type
      STARTED
    2. achievements
      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
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        8
      8. group Id
        FG007
        num Subjects
        7
      9. group Id
        FG008
        num Subjects
        9
      10. group Id
        FG009
        num Subjects
        11
      11. group Id
        FG010
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Participants who were ≥18 years old, had metastatic or locally advanced solid tumors (including multiple myeloma) and failed to respond to standard therapy, or had progressed despite standard therapy, or for whom standard therapy did not exist were recruited for this study.
Complete source fields
groups
  1. description
    Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) intravenous (IV) infusion 1 time every 1 week (Q1W).
    id
    FG000
    title
    Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
  2. description
    Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
    id
    FG001
    title
    Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
  3. description
    Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
    id
    FG002
    title
    Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
  4. description
    Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
    id
    FG003
    title
    Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
  5. description
    Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
    id
    FG004
    title
    Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
  6. description
    Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
    id
    FG005
    title
    Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
  7. description
    Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
    id
    FG006
    title
    Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
  8. description
    Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
    id
    FG007
    title
    Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
  9. description
    Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
    id
    FG008
    title
    Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
  10. description
    Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion 1 time every 2 weeks (Q2W).
    id
    FG009
    title
    Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
  11. description
    Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion 1 time every 3 weeks (Q3W).
    id
    FG010
    title
    Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
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
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        2
      11. group Id
        FG010
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        7
      8. group Id
        FG007
        num Subjects
        7
      9. group Id
        FG008
        num Subjects
        8
      10. group Id
        FG009
        num Subjects
        8
      11. group Id
        FG010
        num Subjects
        11
      type
      Progressive Disease
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      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
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Withdrawal by Subject
    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
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        8
      8. group Id
        FG007
        num Subjects
        7
      9. group Id
        FG008
        num Subjects
        9
      10. group Id
        FG009
        num Subjects
        11
      11. group Id
        FG010
        num Subjects
        11
      type
      STARTED
    2. achievements
      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
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        8
      8. group Id
        FG007
        num Subjects
        7
      9. group Id
        FG008
        num Subjects
        9
      10. group Id
        FG009
        num Subjects
        11
      11. group Id
        FG010
        num Subjects
        11
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Participants who were ≥18 years old, had metastatic or locally advanced solid tumors (including multiple myeloma) and failed to respond to standard therapy, or had progressed despite standard therapy, or for whom standard therapy did not exist were recruited for this study.

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

Preserved source evidence · Not medical advice