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NCT01524978 · FLOW

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A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers · Source last updated 2017-11-20

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

groups
  1. description
    Participants with NSCLC were treated with vemurafenib monotherapy.
    id
    FG000
    title
    Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
  2. description
    Participants with ovarian cancer were treated with vemurafenib monotherapy.
    id
    FG001
    title
    Cohort 2: Ovarian Cancer - Vemurafenib
  3. description
    Participants with colorectal cancer were treated with vemurafenib monotherapy.
    id
    FG002
    title
    Cohort 3a: Colorectal Cancer - Vemurafenib
  4. description
    Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
    id
    FG003
    title
    Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
  5. description
    Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
    id
    FG004
    title
    Cohort 4: Cholangiocarcinoma - Vemurafenib
  6. description
    Participants with multiple myeloma were treated with vemurafenib monotherapy.
    id
    FG005
    title
    Cohort 6: Multiple Myeloma - Vemurafenib
  7. description
    Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
    id
    FG006
    title
    Cohort 7a: ECD/LCH - Vemurafenib
  8. description
    Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
    id
    FG007
    title
    Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
  9. description
    Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
    id
    FG008
    title
    Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
  10. description
    Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
    id
    FG009
    title
    Cohort 7d: Early Stage Astrocytoma - Vemurafenib
  11. description
    Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
    id
    FG010
    title
    Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        17
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        2
      11. group Id
        FG010
        num Subjects
        5
      type
      Other
    2. reasons
      1. group Id
        FG000
        num Subjects
        12
      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
        3
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        4
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        5
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      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
        1
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        1
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        34
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        24
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        9
      9. group Id
        FG008
        num Subjects
        5
      10. group Id
        FG009
        num Subjects
        6
      11. group Id
        FG010
        num Subjects
        17
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        62
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        27
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        9
      7. group Id
        FG006
        num Subjects
        26
      8. group Id
        FG007
        num Subjects
        12
      9. group Id
        FG008
        num Subjects
        12
      10. group Id
        FG009
        num Subjects
        9
      11. group Id
        FG010
        num Subjects
        28
      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
        62
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        27
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        9
      7. group Id
        FG006
        num Subjects
        26
      8. group Id
        FG007
        num Subjects
        12
      9. group Id
        FG008
        num Subjects
        12
      10. group Id
        FG009
        num Subjects
        9
      11. group Id
        FG010
        num Subjects
        28
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
One participant with breast cancer was screened shortly after Cohort 5 (Breast Cancer) had been closed. This participant was allowed to enter the study in Cohort 7: Other BRAF V600-positive tumors. For analysis purposes Cohort 7 was split into sub-cohorts for indications with sufficient participants.
Complete source fields
groups
  1. description
    Participants with NSCLC were treated with vemurafenib monotherapy.
    id
    FG000
    title
    Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - Vemurafenib
  2. description
    Participants with ovarian cancer were treated with vemurafenib monotherapy.
    id
    FG001
    title
    Cohort 2: Ovarian Cancer - Vemurafenib
  3. description
    Participants with colorectal cancer were treated with vemurafenib monotherapy.
    id
    FG002
    title
    Cohort 3a: Colorectal Cancer - Vemurafenib
  4. description
    Participants with colorectal cancer were treated with vemurafenib and cetuximab combination therapy.
    id
    FG003
    title
    Cohort 3b: Colorectal Cancer - Vemurafenib + Cetuximab
  5. description
    Participants with cholangiocarcinoma were treated with vemurafenib monotherapy.
    id
    FG004
    title
    Cohort 4: Cholangiocarcinoma - Vemurafenib
  6. description
    Participants with multiple myeloma were treated with vemurafenib monotherapy.
    id
    FG005
    title
    Cohort 6: Multiple Myeloma - Vemurafenib
  7. description
    Participants with Erdheim-Chester disease (ECD) or Langerhans cell histiocytosis (LCH) were treated with vemurafenib monotherapy.
    id
    FG006
    title
    Cohort 7a: ECD/LCH - Vemurafenib
  8. description
    Participants with anaplastic thyroid cancer were treated with vemurafenib monotherapy.
    id
    FG007
    title
    Cohort 7b: Anaplastic Thyroid Cancer - Vemurafenib
  9. description
    Participants with advanced stage astrocytoma were treated with vemurafenib monotherapy.
    id
    FG008
    title
    Cohort 7c: Advanced Stage Astrocytoma - Vemurafenib
  10. description
    Participants with early stage astrocytoma were treated with vemurafenib monotherapy.
    id
    FG009
    title
    Cohort 7d: Early Stage Astrocytoma - Vemurafenib
  11. description
    Participants with other BRAF V600-positive tumors were treated with vemurafenib monotherapy.
    id
    FG010
    title
    Cohort 7: Other BRAF V600-positive Tumors - Vemurafenib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        17
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        2
      11. group Id
        FG010
        num Subjects
        5
      type
      Other
    2. reasons
      1. group Id
        FG000
        num Subjects
        12
      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
        3
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        4
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        5
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      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
        1
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        1
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        34
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        24
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        9
      9. group Id
        FG008
        num Subjects
        5
      10. group Id
        FG009
        num Subjects
        6
      11. group Id
        FG010
        num Subjects
        17
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        62
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        27
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        9
      7. group Id
        FG006
        num Subjects
        26
      8. group Id
        FG007
        num Subjects
        12
      9. group Id
        FG008
        num Subjects
        12
      10. group Id
        FG009
        num Subjects
        9
      11. group Id
        FG010
        num Subjects
        28
      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
        62
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        27
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        9
      7. group Id
        FG006
        num Subjects
        26
      8. group Id
        FG007
        num Subjects
        12
      9. group Id
        FG008
        num Subjects
        12
      10. group Id
        FG009
        num Subjects
        9
      11. group Id
        FG010
        num Subjects
        28
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
One participant with breast cancer was screened shortly after Cohort 5 (Breast Cancer) had been closed. This participant was allowed to enter the study in Cohort 7: Other BRAF V600-positive tumors. For analysis purposes Cohort 7 was split into sub-cohorts for indications with sufficient participants.

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Preserved source evidence · Not medical advice