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NCT06400238 · FLOW

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Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Expression (MATCH - Subprotocol Z1H) · Source last updated 2026-05-28

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

groups
  1. description
    Patients receive copanlisib 60 mg IV over 60 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients undergo biopsies and blood sample collection on study.
    id
    FG000
    title
    Treatment (Copanlisib)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Started Protocol Therapy
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        27
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        35
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        33
      type
      Started Protocol Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        29
      comment
      Primary efficacy analysis set
      type
      Eligible, Treated and Mutation Status Confirmed
    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
The PTEN mutation status was determined by a CLIA-approved assay performed in NCI-MATCH approved laboratory for all patients in this arm. Thirty-one out of the 35 outside lab patients had their samples centrally confirmed.
recruitment Details
Subprotocol Z1H was activated on June 20, 2018. Thirty-five patients were enrolled between October 2018 and January 2020. All patients were enrolled through the outside laboratory.
Complete source fields
groups
  1. description
    Patients receive copanlisib 60 mg IV over 60 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients undergo biopsies and blood sample collection on study.
    id
    FG000
    title
    Treatment (Copanlisib)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Started Protocol Therapy
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        27
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        35
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        33
      type
      Started Protocol Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        29
      comment
      Primary efficacy analysis set
      type
      Eligible, Treated and Mutation Status Confirmed
    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
The PTEN mutation status was determined by a CLIA-approved assay performed in NCI-MATCH approved laboratory for all patients in this arm. Thirty-one out of the 35 outside lab patients had their samples centrally confirmed.
recruitment Details
Subprotocol Z1H was activated on June 20, 2018. Thirty-five patients were enrolled between October 2018 and January 2020. All patients were enrolled through the outside laboratory.

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Preserved source evidence · Not medical advice