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NCT03213691 · OUTCOME

Response Rate

Selumetinib Sulfate in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial) · Source last updated 2025-02-05

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

Measure
NUMBER
Unit
Percentage of patients
Interval / dispersion
Not reported
Time frame
From enrollment to the end of treatment, up to 2 years

What was measured

A responder is defined as a patient who achieves a best response of partial response (PR) or complete response (CR) on the study. Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method. The revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to determine response and progression in this study, with specific criteria outlined for the different subtypes of tumors (e.g., 2-dimensional measurements for central nervous system (CNS) tumors.

Analysis population: One patient was deemed ineligible by the Study Chair and is excluded from this analysis.

Groups in this outcome

Treatment (Selumetinib)

Patients receive selumetinib sulfate PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Treatment (Selumetinib)20

Reported measurements

Source class 1
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Selumetinib)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
A responder is defined as a patient who achieves a best response of partial response (PR) or complete response (CR) on the study. Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method. The revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to determine response and progression in this study, with specific criteria outlined for the different subtypes of tumors (e.g., 2-dimensional measurements for central nervous system (CNS) tumors.
groups
  1. description
    Patients receive selumetinib sulfate PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Treatment (Selumetinib)
param Type
NUMBER
population Description
One patient was deemed ineligible by the Study Chair and is excluded from this analysis.
reporting Status
POSTED
time Frame
From enrollment to the end of treatment, up to 2 years
title
Response Rate
type
PRIMARY
unit Of Measure
Percentage of patients

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

Preserved source evidence · Not medical advice