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NCT04439188 · FLOW

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Testing GSK2636771 as a Potential Targeted Treatment in Cancers With PTEN Loss of Expression (MATCH-Subprotocol P) · 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 400 mg 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
        3
      type
      Ineligible
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        25
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        35
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        35
      type
      Started Protocol Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        32
      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
        35
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients who had tumor with complete loss of cytoplasmic and nuclear staining for PTEN with IHC were assigned to sub-protocol P. The mutation status was determined by MATCH central Oncomine assay for all patients in this arm.
recruitment Details
Subprotocol P was activated on February 25, 2016. Thirty-five patients were enrolled on EAY131-P between March 21, 2016, and February 17, 2017. 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 400 mg 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
        3
      type
      Ineligible
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        25
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        35
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        35
      type
      Started Protocol Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        32
      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
        35
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients who had tumor with complete loss of cytoplasmic and nuclear staining for PTEN with IHC were assigned to sub-protocol P. The mutation status was determined by MATCH central Oncomine assay for all patients in this arm.
recruitment Details
Subprotocol P was activated on February 25, 2016. Thirty-five patients were enrolled on EAY131-P between March 21, 2016, and February 17, 2017. 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