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NCT04439149 · FLOW

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Testing GSK2636771 as a Potential Targeted Treatment in Cancers With PTEN Genetic Changes (MATCH-Subprotocol N) · Source last updated 2026-05-27

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

groups
  1. description
    Patients receive PI3K-beta inhibitor GSK2636771 400mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. PI3K-beta Inhibitor GSK2636771: Given PO
    id
    FG000
    title
    Treatment (GSK2636771)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Ineligible
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Never start protocol therapy
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        14
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Complicating disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        23
      type
      Started Protocol Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        22
      comment
      Primary efficacy analysis set
      type
      Eligible and Treated
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients whose tumors harboring PTEN mutation/deletion without loss of PTEN protein expression were assigned to sub-protocol N. The mutation status was determined by MATCH central Oncomine assay for all patients in this arm.
recruitment Details
Subprotocol N was activated on February 25, 2016. Twenty-four patients were enrolled on EAY131-N between May 5, 2016, and December 5, 2016. All patients were enrolled on the basis of the results from the NCI-MATCH assay.
Complete source fields
groups
  1. description
    Patients receive PI3K-beta inhibitor GSK2636771 400mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. PI3K-beta Inhibitor GSK2636771: Given PO
    id
    FG000
    title
    Treatment (GSK2636771)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Ineligible
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Never start protocol therapy
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        14
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Complicating disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        23
      type
      Started Protocol Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        22
      comment
      Primary efficacy analysis set
      type
      Eligible and Treated
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients whose tumors harboring PTEN mutation/deletion without loss of PTEN protein expression were assigned to sub-protocol N. The mutation status was determined by MATCH central Oncomine assay for all patients in this arm.
recruitment Details
Subprotocol N was activated on February 25, 2016. Twenty-four patients were enrolled on EAY131-N between May 5, 2016, and December 5, 2016. All patients were enrolled on the basis of the results from the NCI-MATCH assay.

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Preserved source evidence · Not medical advice