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NCT04439175 · FLOW

Participant flow

Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I) · Source last updated 2026-05-06

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

groups
  1. description
    Patients receive taselisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Taselisib: Given PO
    id
    FG000
    title
    Treatment (Taselisib)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Never started treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Ineligible
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        44
      type
      Disease progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Alternative Therapy
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        70
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        66
      type
      Started Protocol Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        61
      comment
      Four patients did not initiate protocol therapy and five patients initiated therapy but were subsequently found to be ineligible by central review. This is the primary analysis population.
      type
      Eligible and Started Protocol Therapy
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      comment
      Treatment continued until disease progression or intolerability.
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        70
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
To be assigned to a specific MATCH subprotocol, patients needed to submit a tumor biopsy for molecular characterization and those with molecular variants addressed by treatments included in the trial entered corresponding MATCH subprotocol. For subprotocol W, patients had to have tumors with an activating PIK3CA mutation.
recruitment Details
Subprotocol I was activated on February 25, 2016. 97 patients were assigned to Subprotocol I after screening, all from the screening cohort. Of the 97 patients, 70 patients enrolled in the study between March 2016 and April 2017.
Complete source fields
groups
  1. description
    Patients receive taselisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Taselisib: Given PO
    id
    FG000
    title
    Treatment (Taselisib)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Never started treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Ineligible
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        44
      type
      Disease progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Alternative Therapy
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        70
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        66
      type
      Started Protocol Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        61
      comment
      Four patients did not initiate protocol therapy and five patients initiated therapy but were subsequently found to be ineligible by central review. This is the primary analysis population.
      type
      Eligible and Started Protocol Therapy
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      comment
      Treatment continued until disease progression or intolerability.
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        70
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
To be assigned to a specific MATCH subprotocol, patients needed to submit a tumor biopsy for molecular characterization and those with molecular variants addressed by treatments included in the trial entered corresponding MATCH subprotocol. For subprotocol W, patients had to have tumors with an activating PIK3CA mutation.
recruitment Details
Subprotocol I was activated on February 25, 2016. 97 patients were assigned to Subprotocol I after screening, all from the screening cohort. Of the 97 patients, 70 patients enrolled in the study between March 2016 and April 2017.

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Preserved source evidence · Not medical advice