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NCT06400251 · FLOW

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Testing Ipatasertib as Potentially Targeted Treatment in Cancers With AKT Genetic Changes (MATCH - Subprotocol Z1K) · Source last updated 2026-06-01

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

groups
  1. description
    Patients receive ipatasertib 400 mg PO QD on days 1-28 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 (Ipatasertib)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Never Start Protocol Therapy
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Ineligible
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Mutation Status Not Confirmed
    4. reasons
      1. group Id
        FG000
        num Subjects
        25
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Complicating Disease
    7. 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
        34
      type
      Started Protocol Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        32
      type
      Eligible and Treated
    4. achievements
      1. group Id
        FG000
        num Subjects
        29
      comment
      Primary efficacy analysis set
      type
      Eligible, Treated and Mutation Status Confirmed
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        35
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients with tumors harboring E17K mutations in AKT1, 2, and 3, as well as Q79K and L52R mutations in AKT1, were eligible for sub-protocol Z1K. The mutation status was determined by an NCI-MATCH approved laboratory for all patients in this arm, they had to be confirmed by the NCI-MATCH central assay to be included in primary analysis.
recruitment Details
Subprotocol Z1K was activated on July 25, 2019. Thirty-five patients were enrolled on EAY131-Z1K between August 8, 2019, and November 11, 2020. All patients were enrolled on the basis of the outside lab assay results.
Complete source fields
groups
  1. description
    Patients receive ipatasertib 400 mg PO QD on days 1-28 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 (Ipatasertib)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Never Start Protocol Therapy
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Ineligible
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Mutation Status Not Confirmed
    4. reasons
      1. group Id
        FG000
        num Subjects
        25
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Complicating Disease
    7. 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
        34
      type
      Started Protocol Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        32
      type
      Eligible and Treated
    4. achievements
      1. group Id
        FG000
        num Subjects
        29
      comment
      Primary efficacy analysis set
      type
      Eligible, Treated and Mutation Status Confirmed
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        35
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients with tumors harboring E17K mutations in AKT1, 2, and 3, as well as Q79K and L52R mutations in AKT1, were eligible for sub-protocol Z1K. The mutation status was determined by an NCI-MATCH approved laboratory for all patients in this arm, they had to be confirmed by the NCI-MATCH central assay to be included in primary analysis.
recruitment Details
Subprotocol Z1K was activated on July 25, 2019. Thirty-five patients were enrolled on EAY131-Z1K between August 8, 2019, and November 11, 2020. All patients were enrolled on the basis of the outside lab assay results.

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Preserved source evidence · Not medical advice