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NCT06390852 · FLOW

Participant flow

Testing LOXO-101 as Potentially Targeted Treatment in Cancers With NTRK Genetic Changes (MATCH - Subprotocol Z1E) · Source last updated 2026-09-01

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

groups
  1. description
    Patients receive larotrectinib (LOXO-101) 100 mg PO BID 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 also undergo biopsies and blood sample collection on study.
    id
    FG000
    title
    Treatment (Larotrectinib [LOXO-101])
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Ineligible
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Mutation Status Not Confirmed
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Still on Therapy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      Started Protocol Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        15
      type
      Eligible
    4. achievements
      1. group Id
        FG000
        num Subjects
        12
      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
        16
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients were assigned to subprotocol Z1E if an NTRK fusion-positive tumor was identified. The mutation status was determined by an NCI-MATCH approved laboratory for all 16 patients in this arm. These cases had to be confirmed to be used in primary analysis.
recruitment Details
Subprotocol Z1E was activated on March 13, 2017. Between August 21, 2017, and July 8, 2021, 16 patients were enrolled in subprotocol Z1E. All were enrolled on the basis of the outside assay results.
Complete source fields
groups
  1. description
    Patients receive larotrectinib (LOXO-101) 100 mg PO BID 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 also undergo biopsies and blood sample collection on study.
    id
    FG000
    title
    Treatment (Larotrectinib [LOXO-101])
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Ineligible
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Mutation Status Not Confirmed
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Still on Therapy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        16
      type
      Started Protocol Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        15
      type
      Eligible
    4. achievements
      1. group Id
        FG000
        num Subjects
        12
      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
        16
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients were assigned to subprotocol Z1E if an NTRK fusion-positive tumor was identified. The mutation status was determined by an NCI-MATCH approved laboratory for all 16 patients in this arm. These cases had to be confirmed to be used in primary analysis.
recruitment Details
Subprotocol Z1E was activated on March 13, 2017. Between August 21, 2017, and July 8, 2021, 16 patients were enrolled in subprotocol Z1E. All were enrolled on the basis of the outside assay results.

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Preserved source evidence · Independent clinical review pending · Not medical advice