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NCT03389802 · OUTCOME

Duration of Response for Stratum 2 (DIPG) 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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to 2 years

What was measured

Complete or partial responses were considered responses. Response was evaluated by imaging or clinical progression. Duration of response was measured from the time measurement criteria are met for complete or partial response until the first date that recurrent or progressive disease was objectively documented.

Analysis population: Of the 11 Stratum 2 patients (6 dose level 2, 5 dose level 3), 2 (both in dose level 3) were considered not evaluable for response. As no participants had complete or partial responses, it was not possible to calculate duration of response.

Groups in this outcome

Stratum 2, Dose Level 2

Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) 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 2, Dose Level 3

Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) 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 2, Dose Level 20
Stratum 2, Dose Level 30

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Complete or partial responses were considered responses. Response was evaluated by imaging or clinical progression. Duration of response was measured from the time measurement criteria are met for complete or partial response until the first date that recurrent or progressive disease was objectively documented.
groups
  1. description
    Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) 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
    OG000
    title
    Stratum 2, Dose Level 2
  2. description
    Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) 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
    OG001
    title
    Stratum 2, Dose Level 3
population Description
Of the 11 Stratum 2 patients (6 dose level 2, 5 dose level 3), 2 (both in dose level 3) were considered not evaluable for response. As no participants had complete or partial responses, it was not possible to calculate duration of response.
reporting Status
POSTED
time Frame
Up to 2 years
title
Duration of Response for Stratum 2 (DIPG) Patients
type
SECONDARY

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

Preserved source evidence · Not medical advice