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NCT01362790 · FLOW

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SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma · Source last updated 2019-06-06

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

groups
  1. description
    Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
    id
    FG000
    title
    Mesothelioma Pilot Phase Regimen A
  2. description
    Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.
    id
    FG001
    title
    Mesothelioma Pilot Phase Regimen B
  3. description
    Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
    id
    FG002
    title
    Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
  4. description
    Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
    id
    FG003
    title
    Phase 2 Pleural Mesothelioma Pilot Expansion Phase
  5. description
    Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles. During Phase 2 SS1P was administered from 2 different Lots at 35mcg/kg (Lot F1L129J01 and Lot07310809). It was discovered that Lot F1L129J01 was more potent than Lot 07310809, therefore, a dose de-escalation was done for 8 participants who received that Lot to determine the MTD specific to the Lot.
    id
    FG004
    title
    Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A
  6. description
    Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
    id
    FG005
    title
    Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
  7. description
    Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
    id
    FG006
    title
    Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
periods
  1. drop Withdraws
    1. reasons
      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
      Changed treatment, too early to assess
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      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
        2
      7. group Id
        FG006
        num Subjects
        0
      type
      Adverse Event
    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
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Developed antibodies
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      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
      Refused further treatment
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      type
      Progressive disease
    7. reasons
      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
      Treatment delay >3 weeks
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      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
      Complicating disease/intercurr. illness
    9. 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
      Death on study
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        15
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      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
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        14
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Pilot Phase & Phase 2
  2. 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
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        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
        0
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Deveoped antibodies
    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
        0
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Progressive disease
    milestones
    1. 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
        8
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        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
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      COMPLETED
    3. 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
        6
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Dose De-escalation of Regimen A
pre Assignment Details
55 participants were enrolled. No data was collected for 10/55 participants who were screened for neutralizing antibodies and were positive, thus not enrolled into a Group /Arm, nor treated. 45/55 participants were treated on this study.
Complete source fields
groups
  1. description
    Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
    id
    FG000
    title
    Mesothelioma Pilot Phase Regimen A
  2. description
    Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\^2 or 2 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\^2 on days 1 and 5 of 25 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle Other Names: • Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.
    id
    FG001
    title
    Mesothelioma Pilot Phase Regimen B
  3. description
    Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
    id
    FG002
    title
    Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase
  4. description
    Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
    id
    FG003
    title
    Phase 2 Pleural Mesothelioma Pilot Expansion Phase
  5. description
    Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles. During Phase 2 SS1P was administered from 2 different Lots at 35mcg/kg (Lot F1L129J01 and Lot07310809). It was discovered that Lot F1L129J01 was more potent than Lot 07310809, therefore, a dose de-escalation was done for 8 participants who received that Lot to determine the MTD specific to the Lot.
    id
    FG004
    title
    Mesothelioma Positive Ca Dose De-escalation Pilot Regimen A
  6. description
    Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
    id
    FG005
    title
    Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A
  7. description
    Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\^2 on day 1 of 21 day cycle Other Names: • Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Other Names: • Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.
    id
    FG006
    title
    Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A
periods
  1. drop Withdraws
    1. reasons
      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
      Changed treatment, too early to assess
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      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
        2
      7. group Id
        FG006
        num Subjects
        0
      type
      Adverse Event
    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
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Developed antibodies
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      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
      Refused further treatment
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      type
      Progressive disease
    7. reasons
      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
      Treatment delay >3 weeks
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      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
      Complicating disease/intercurr. illness
    9. 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
      Death on study
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        7
      4. group Id
        FG003
        num Subjects
        15
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      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
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        14
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Pilot Phase & Phase 2
  2. 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
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        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
        0
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Deveoped antibodies
    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
        0
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Progressive disease
    milestones
    1. 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
        8
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        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
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      COMPLETED
    3. 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
        6
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Dose De-escalation of Regimen A
pre Assignment Details
55 participants were enrolled. No data was collected for 10/55 participants who were screened for neutralizing antibodies and were positive, thus not enrolled into a Group /Arm, nor treated. 45/55 participants were treated on this study.

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