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NCT05185947 · FLOW

Participant flow

Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis · Source last updated 2026-06-25

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

groups
  1. description
    Participants were enrolled, assigned to Arm/Cohort = 1/Peritoneal Carcinomatosis Arm = 1/Intraperitoneal (IP) Catheter Placement and Bidirectional Chemotherapy Dose Level = DL 1 intravenous (IV) Paclitaxel Cycle 1 Day 2 (C1D2) 60mg/m\^2 then 80mg/m\^2 DL 1 intraperitoneal (IP) Paclitaxel Cycles 1-3 60mg/m\^2 then Cycles 4-6 80mg/m\^2 DL 1 by mouth (PO) Nilotinib 300mg twice a day (BID). Participants enrolled, assigned to an Arm/Cohort, and start protocol treatment.
    id
    FG000
    title
    Participants Enrolled, Assigned to Cohort 1/Arm 1 Peritoneal Carcinomatosis, and Treated
  2. description
    Participants were enrolled, assigned to Arm/(Cohort = 1/Peritoneal Carcinomatosis Arm = 1/Intraperitoneal (IP) Catheter Placement and Bidirectional Chemotherapy Dose Level = DL 1 intravenous (IV) Paclitaxel Cycle 1 Day 2 (C1D2) 60mg/m\^2 then 80mg/m\^2 DL 1 intraperitoneal (IP) Paclitaxel Cycles 1-3 60mg/m\^2 then Cycles 4-6 80mg/m\^2 DL 1 by mouth (PO) Nilotinib 300mg twice a day (BID)); but opted to come off-study prior to start of protocol treatment.
    id
    FG001
    title
    Participants Enrolled, Assigned to an Arm/Cohort, But Not Treated
  3. description
    Participants were enrolled, were not assigned to an Arm/Cohort and were not treated.
    id
    FG002
    title
    Participants Enrolled, Not Assigned to an Arm/Cohort and Not Treated
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Refused further treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Stopped treatment before completing 6 cycles of therapy due to clinical progression of disease.
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        8
      type
      Ineligible
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Screen failure
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Participant refused
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        12
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      De-escalated Nilotinib Dose
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      De-escalated Intravenous (IV) Paclitaxel Dose
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      De-escalated Intraperitoneal (IP) Paclitaxel Dose
    5. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        12
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Participants were enrolled, assigned to Arm/Cohort = 1/Peritoneal Carcinomatosis Arm = 1/Intraperitoneal (IP) Catheter Placement and Bidirectional Chemotherapy Dose Level = DL 1 intravenous (IV) Paclitaxel Cycle 1 Day 2 (C1D2) 60mg/m\^2 then 80mg/m\^2 DL 1 intraperitoneal (IP) Paclitaxel Cycles 1-3 60mg/m\^2 then Cycles 4-6 80mg/m\^2 DL 1 by mouth (PO) Nilotinib 300mg twice a day (BID). Participants enrolled, assigned to an Arm/Cohort, and start protocol treatment.
    id
    FG000
    title
    Participants Enrolled, Assigned to Cohort 1/Arm 1 Peritoneal Carcinomatosis, and Treated
  2. description
    Participants were enrolled, assigned to Arm/(Cohort = 1/Peritoneal Carcinomatosis Arm = 1/Intraperitoneal (IP) Catheter Placement and Bidirectional Chemotherapy Dose Level = DL 1 intravenous (IV) Paclitaxel Cycle 1 Day 2 (C1D2) 60mg/m\^2 then 80mg/m\^2 DL 1 intraperitoneal (IP) Paclitaxel Cycles 1-3 60mg/m\^2 then Cycles 4-6 80mg/m\^2 DL 1 by mouth (PO) Nilotinib 300mg twice a day (BID)); but opted to come off-study prior to start of protocol treatment.
    id
    FG001
    title
    Participants Enrolled, Assigned to an Arm/Cohort, But Not Treated
  3. description
    Participants were enrolled, were not assigned to an Arm/Cohort and were not treated.
    id
    FG002
    title
    Participants Enrolled, Not Assigned to an Arm/Cohort and Not Treated
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Refused further treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Stopped treatment before completing 6 cycles of therapy due to clinical progression of disease.
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        8
      type
      Ineligible
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      type
      Screen failure
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Participant refused
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        12
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      De-escalated Nilotinib Dose
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      De-escalated Intravenous (IV) Paclitaxel Dose
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      De-escalated Intraperitoneal (IP) Paclitaxel Dose
    5. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        12
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice