Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02601209 · FLOW

Participant flow

Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma · Source last updated 2022-08-23

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

groups
  1. description
    Protocol therapy will consist of 20 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
    id
    FG000
    title
    Phase I - Dose Level 0
  2. description
    Protocol therapy will consist of 25 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
    id
    FG001
    title
    Phase I - Dose Level 1
  3. description
    Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
    id
    FG002
    title
    Phase I - Dose Level 2
  4. description
    Patients receive 800mg Pazopanib orally once daily over a 4-week cycle in the first intervention period/initial treatment period.
    id
    FG003
    title
    Phase II - Analysis Group 1 Pazopanib
  5. description
    Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
    id
    FG004
    title
    Phase II - Analysis Group 1 MLN0128
  6. description
    Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.
    id
    FG005
    title
    Phase II - Analysis Group 2 Pazopanib
  7. description
    Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
    id
    FG006
    title
    Phase II - Analysis Group 2 MLN0128
  8. description
    Patients receive 800mg Pazopanib orally once daily over a 4-week cycle in the first intervention period/initial treatment period. Patients who chose to crossover (crossover to MLN0128 is optional) receive 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle in the second intervention period/optional crossover period.
    id
    FG007
    title
    Phase II - Analysis Group 1 Pazopanib Crossover
  9. description
    Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period. Patients who chose to crossover (crossover to MLN0128 is optional) receive 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle in the second intervention period/optional crossover period.
    id
    FG008
    title
    Phase II - Analysis Group 2 Pazopanib Crossover
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      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
      type
      Did not meet eligibility criteria
    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
        1
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      Withdrew before initiation of regimen
    milestones
    1. achievements
      1. comment
        Pre-registered
        group Id
        FG000
        num Subjects
        4
      2. comment
        Pre-registered
        group Id
        FG001
        num Subjects
        4
      3. comment
        Pre-registered
        group Id
        FG002
        num Subjects
        4
      4. comment
        Randomized
        group Id
        FG003
        num Subjects
        6
      5. comment
        Randomized
        group Id
        FG004
        num Subjects
        13
      6. comment
        Randomized
        group Id
        FG005
        num Subjects
        15
      7. comment
        Randomized
        group Id
        FG006
        num Subjects
        56
      8. comment
        Randomized
        group Id
        FG007
        num Subjects
        6
      9. comment
        Randomized
        group Id
        FG008
        num Subjects
        43
      type
      STARTED
    2. achievements
      1. comment
        Registered
        group Id
        FG000
        num Subjects
        3
      2. comment
        Registered
        group Id
        FG001
        num Subjects
        3
      3. comment
        Registered
        group Id
        FG002
        num Subjects
        3
      4. comment
        Received treatment; included in safety analysis
        group Id
        FG003
        num Subjects
        6
      5. comment
        Received treatment; included in safety analysis
        group Id
        FG004
        num Subjects
        12
      6. comment
        Received treatment; included in safety analysis
        group Id
        FG005
        num Subjects
        13
      7. comment
        Received treatment; included in safety analysis
        group Id
        FG006
        num Subjects
        55
      8. comment
        Received treatment; included in safety analysis
        group Id
        FG007
        num Subjects
        6
      9. comment
        Received treatment; included in safety analysis
        group Id
        FG008
        num Subjects
        43
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      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
        2
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Initial Treatment (Up to 4 Months)
  2. 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
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. comment
        PD on pazopanib
        group Id
        FG007
        num Subjects
        6
      9. comment
        PD on pazopanib
        group Id
        FG008
        num Subjects
        43
      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. comment
        Initiated crossover to MLN0128 following PD on pazopanib
        group Id
        FG007
        num Subjects
        4
      9. comment
        Initiated crossover to MLN0128 following PD on pazopanib
        group Id
        FG008
        num Subjects
        26
      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
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        17
      type
      NOT COMPLETED
    title
    Optional Crossover (Up to 2 Months)
pre Assignment Details
Phase II Analysis Group 1: 32 Patients pre-registered; 7 did not pass screening, leaving 25 to proceed to randomization. Phase II Analysis Group 2: 166 Patients pre-registered; 52 did not pass screening, leaving 114 to proceed to randomization.
Complete source fields
groups
  1. description
    Protocol therapy will consist of 20 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
    id
    FG000
    title
    Phase I - Dose Level 0
  2. description
    Protocol therapy will consist of 25 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
    id
    FG001
    title
    Phase I - Dose Level 1
  3. description
    Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.
    id
    FG002
    title
    Phase I - Dose Level 2
  4. description
    Patients receive 800mg Pazopanib orally once daily over a 4-week cycle in the first intervention period/initial treatment period.
    id
    FG003
    title
    Phase II - Analysis Group 1 Pazopanib
  5. description
    Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
    id
    FG004
    title
    Phase II - Analysis Group 1 MLN0128
  6. description
    Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.
    id
    FG005
    title
    Phase II - Analysis Group 2 Pazopanib
  7. description
    Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
    id
    FG006
    title
    Phase II - Analysis Group 2 MLN0128
  8. description
    Patients receive 800mg Pazopanib orally once daily over a 4-week cycle in the first intervention period/initial treatment period. Patients who chose to crossover (crossover to MLN0128 is optional) receive 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle in the second intervention period/optional crossover period.
    id
    FG007
    title
    Phase II - Analysis Group 1 Pazopanib Crossover
  9. description
    Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period. Patients who chose to crossover (crossover to MLN0128 is optional) receive 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle in the second intervention period/optional crossover period.
    id
    FG008
    title
    Phase II - Analysis Group 2 Pazopanib Crossover
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      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
      type
      Did not meet eligibility criteria
    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
        1
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      Withdrew before initiation of regimen
    milestones
    1. achievements
      1. comment
        Pre-registered
        group Id
        FG000
        num Subjects
        4
      2. comment
        Pre-registered
        group Id
        FG001
        num Subjects
        4
      3. comment
        Pre-registered
        group Id
        FG002
        num Subjects
        4
      4. comment
        Randomized
        group Id
        FG003
        num Subjects
        6
      5. comment
        Randomized
        group Id
        FG004
        num Subjects
        13
      6. comment
        Randomized
        group Id
        FG005
        num Subjects
        15
      7. comment
        Randomized
        group Id
        FG006
        num Subjects
        56
      8. comment
        Randomized
        group Id
        FG007
        num Subjects
        6
      9. comment
        Randomized
        group Id
        FG008
        num Subjects
        43
      type
      STARTED
    2. achievements
      1. comment
        Registered
        group Id
        FG000
        num Subjects
        3
      2. comment
        Registered
        group Id
        FG001
        num Subjects
        3
      3. comment
        Registered
        group Id
        FG002
        num Subjects
        3
      4. comment
        Received treatment; included in safety analysis
        group Id
        FG003
        num Subjects
        6
      5. comment
        Received treatment; included in safety analysis
        group Id
        FG004
        num Subjects
        12
      6. comment
        Received treatment; included in safety analysis
        group Id
        FG005
        num Subjects
        13
      7. comment
        Received treatment; included in safety analysis
        group Id
        FG006
        num Subjects
        55
      8. comment
        Received treatment; included in safety analysis
        group Id
        FG007
        num Subjects
        6
      9. comment
        Received treatment; included in safety analysis
        group Id
        FG008
        num Subjects
        43
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      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
        2
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Initial Treatment (Up to 4 Months)
  2. 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
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. comment
        PD on pazopanib
        group Id
        FG007
        num Subjects
        6
      9. comment
        PD on pazopanib
        group Id
        FG008
        num Subjects
        43
      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. comment
        Initiated crossover to MLN0128 following PD on pazopanib
        group Id
        FG007
        num Subjects
        4
      9. comment
        Initiated crossover to MLN0128 following PD on pazopanib
        group Id
        FG008
        num Subjects
        26
      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
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        17
      type
      NOT COMPLETED
    title
    Optional Crossover (Up to 2 Months)
pre Assignment Details
Phase II Analysis Group 1: 32 Patients pre-registered; 7 did not pass screening, leaving 25 to proceed to randomization. Phase II Analysis Group 2: 166 Patients pre-registered; 52 did not pass screening, leaving 114 to proceed to randomization.

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

Preserved source evidence · Not medical advice