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NCT00831844 · FLOW

Participant flow

Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors · Source last updated 2015-03-30

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

groups
  1. description
    Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG000
    title
    Group 1 - Recurrent or Refractory Hepatoblastoma
  2. description
    Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG001
    title
    Group 2 - Recurrent or Refractory Synovial Sarcoma
  3. description
    Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG002
    title
    Group 3 - Recurrent or Refractory Rhabdomyosarcoma
  4. description
    Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG003
    title
    Grp 4-Recurrent or Refractory Adrenocortical Carcinoma
  5. description
    Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG004
    title
    Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  6. description
    Group 6 - Recurrent or Refractory Neuroblastoma -meta-iodobenzylguanidine (MIBG) Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG005
    title
    Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease
  7. description
    Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG006
    title
    Grp 7-Neuroblastoma With Measurable Disease
  8. description
    Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG007
    title
    Group 8 - Recurrent Osteosarcoma
  9. description
    Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG008
    title
    Group 9 - Recurrent or Refractory Wilms Tumor
  10. description
    Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG009
    title
    Group 10 - Recurrent or Refractory Retinoblastoma
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      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
        1
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Adverse Event
    2. 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
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        11
      6. group Id
        FG005
        num Subjects
        17
      7. group Id
        FG006
        num Subjects
        8
      8. group Id
        FG007
        num Subjects
        9
      9. group Id
        FG008
        num Subjects
        7
      10. group Id
        FG009
        num Subjects
        0
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      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
        0
      type
      Physician Decision
    5. 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
        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
        1
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      type
      Withdrawal by Subject
    6. 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
        1
      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
      type
      Ineligible
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        21
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        14
      6. group Id
        FG005
        num Subjects
        20
      7. group Id
        FG006
        num Subjects
        10
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        9
      10. group Id
        FG009
        num Subjects
        0
      type
      STARTED
    2. achievements
      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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      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
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        20
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        14
      6. group Id
        FG005
        num Subjects
        19
      7. group Id
        FG006
        num Subjects
        10
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        9
      10. group Id
        FG009
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
No patients were enrolled in Group 10, recurrent or refractory retinoblastoma.
Complete source fields
groups
  1. description
    Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG000
    title
    Group 1 - Recurrent or Refractory Hepatoblastoma
  2. description
    Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG001
    title
    Group 2 - Recurrent or Refractory Synovial Sarcoma
  3. description
    Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG002
    title
    Group 3 - Recurrent or Refractory Rhabdomyosarcoma
  4. description
    Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG003
    title
    Grp 4-Recurrent or Refractory Adrenocortical Carcinoma
  5. description
    Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG004
    title
    Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  6. description
    Group 6 - Recurrent or Refractory Neuroblastoma -meta-iodobenzylguanidine (MIBG) Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG005
    title
    Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease
  7. description
    Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG006
    title
    Grp 7-Neuroblastoma With Measurable Disease
  8. description
    Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG007
    title
    Group 8 - Recurrent Osteosarcoma
  9. description
    Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG008
    title
    Group 9 - Recurrent or Refractory Wilms Tumor
  10. description
    Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV laboratory biomarker analysis: Correlative studies
    id
    FG009
    title
    Group 10 - Recurrent or Refractory Retinoblastoma
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      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
        1
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Adverse Event
    2. 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
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        11
      6. group Id
        FG005
        num Subjects
        17
      7. group Id
        FG006
        num Subjects
        8
      8. group Id
        FG007
        num Subjects
        9
      9. group Id
        FG008
        num Subjects
        7
      10. group Id
        FG009
        num Subjects
        0
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      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
        0
      type
      Physician Decision
    5. 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
        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
        1
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      type
      Withdrawal by Subject
    6. 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
        1
      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
      type
      Ineligible
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        21
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        14
      6. group Id
        FG005
        num Subjects
        20
      7. group Id
        FG006
        num Subjects
        10
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        9
      10. group Id
        FG009
        num Subjects
        0
      type
      STARTED
    2. achievements
      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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      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
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        20
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        14
      6. group Id
        FG005
        num Subjects
        19
      7. group Id
        FG006
        num Subjects
        10
      8. group Id
        FG007
        num Subjects
        10
      9. group Id
        FG008
        num Subjects
        9
      10. group Id
        FG009
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
No patients were enrolled in Group 10, recurrent or refractory retinoblastoma.

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Preserved source evidence · Not medical advice