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NCT03389802 · OUTCOME

Progression-free Survival for Stratum 1 (Recurrent/Refractory) Patients

Phase I Study of APX005M in Pediatric Central Nervous System Tumors · Source last updated 2026-08-13

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

Measure
NUMBER
Unit
Percent probability
Interval / dispersion
95% Confidence Interval
Time frame
1 year

What was measured

Progression-free survival (PFS) was defined as the time interval from treatment initiation to date of first event (relapsed or progressive disease based on imaging or clinical progression or death from any cause) or to the date of last follow-up for patients without events. PFS was estimated using the method of Kaplan and Meier. The 1-year estimate of PFS is reported with a 95% confidence interval. PFS estimates were reported separately by dose level. Stratum 1 patients were those with recurrent or refractory primary malignant CNS tumors.

Analysis population: Ineligible stratum 1 patients were excluded from this analysis.

Groups in this outcome

Stratum 1, Dose Level 1

Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.1 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.

Stratum 1, Dose Level 2

Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.

Stratum 1, Dose Level 3

Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.

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

Analysis denominator · Participants

GroupSource count
Stratum 1, Dose Level 13
Stratum 1, Dose Level 23
Stratum 1, Dose Level 314

Reported measurements

Source class 1
Values in Percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Stratum 1, Dose Level 10.00Not reported00Not reported
Stratum 1, Dose Level 20Not reported00Not reported
Stratum 1, Dose Level 310.7Not reported0.059.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0.00
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        0
        value
        0
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        59.9
        value
        10.7
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      14
    units
    Participants
description
Progression-free survival (PFS) was defined as the time interval from treatment initiation to date of first event (relapsed or progressive disease based on imaging or clinical progression or death from any cause) or to the date of last follow-up for patients without events. PFS was estimated using the method of Kaplan and Meier. The 1-year estimate of PFS is reported with a 95% confidence interval. PFS estimates were reported separately by dose level. Stratum 1 patients were those with recurrent or refractory primary malignant CNS tumors.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.1 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
    id
    OG000
    title
    Stratum 1, Dose Level 1
  2. description
    Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
    id
    OG001
    title
    Stratum 1, Dose Level 2
  3. description
    Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.
    id
    OG002
    title
    Stratum 1, Dose Level 3
param Type
NUMBER
population Description
Ineligible stratum 1 patients were excluded from this analysis.
reporting Status
POSTED
time Frame
1 year
title
Progression-free Survival for Stratum 1 (Recurrent/Refractory) Patients
type
SECONDARY
unit Of Measure
Percent probability

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

Preserved source evidence · Not medical advice