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NCT06357988 · FLOW

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Testing GDC-0449 (Vismodegib) as Potentially Targeted Treatment in Cancers With Smoothened or Patched 1 Mutant Tumors (MATCH - Subprotocol T) · 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 vismodegib 150 mg orally (PO) daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Treatment (Vismodegib)
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
        6
      type
      Mutation Status Not Confirmed
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        15
      type
      Disease Progression
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Other Complicating Disease
    8. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        34
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        33
      type
      Started Protocol Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        25
      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
        34
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients with Patched-1 (PTCH1) and Smoothened (SMO) alterations (excluding basal cell carcinoma) were assigned to sub-protocol T. The mutation status was determined by an NCI-MATCH approved laboratory for 19 patients in this arm, these cases had to be confirmed to be used in primary analysis.
recruitment Details
Subprotocol T was activated on February 25, 2016. Thirty-four patients were enrolled on EAY131-T between June 20, 2016, and September 22, 2020. Fifteen patients were enrolled on the basis of the results from the NCI-MATCH assay and 19 on the basis of the outside assay results.
Complete source fields
groups
  1. description
    Patients receive vismodegib 150 mg orally (PO) daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Treatment (Vismodegib)
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
        6
      type
      Mutation Status Not Confirmed
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        15
      type
      Disease Progression
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Other Complicating Disease
    8. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        34
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        33
      type
      Started Protocol Therapy
    3. achievements
      1. group Id
        FG000
        num Subjects
        25
      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
        34
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Patients with Patched-1 (PTCH1) and Smoothened (SMO) alterations (excluding basal cell carcinoma) were assigned to sub-protocol T. The mutation status was determined by an NCI-MATCH approved laboratory for 19 patients in this arm, these cases had to be confirmed to be used in primary analysis.
recruitment Details
Subprotocol T was activated on February 25, 2016. Thirty-four patients were enrolled on EAY131-T between June 20, 2016, and September 22, 2020. Fifteen patients were enrolled on the basis of the results from the NCI-MATCH assay and 19 on the basis of the outside assay results.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice