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NCT02639546 · OUTCOME

OS for Participants With High-Grade Glioma (HGG) (Phase I) and Low-Grade Glioma (LGG) (Phase I and II)

Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors · Source last updated 2022-09-16

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Baseline until death due to any cause (up to 5 years, 2 months)

What was measured

OS was defined as the time from initiation of study drug to death from any cause. While the data for LGG in the phase II cohort is presented separately in other parts of the record, it was also considered useful to combine the data for LGG from phase I and phase II, which was done here.

Analysis population: The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. For phase II, only one tumor type cohort was opened (LGG). As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type.

Groups in this outcome

High Grade Glioma

Participants with High Grade Glioma.

Low Grade Glioma

Participants with Low Grade Glioma.

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

Analysis denominator · Participants

GroupSource count
High Grade Glioma5
Low Grade Glioma32

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
High Grade Glioma1.4Not reported0.6NAThe upper limit cannot be calculated due to insufficient number of events.
Low Grade GliomaNANot reportedNANANo participants experienced an event and DOR was not reached.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper limit cannot be calculated due to insufficient number of events.
        group Id
        OG000
        lower Limit
        0.6
        upper Limit
        NA
        value
        1.4
      2. comment
        No participants experienced an event and DOR was not reached.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      32
    units
    Participants
description
OS was defined as the time from initiation of study drug to death from any cause. While the data for LGG in the phase II cohort is presented separately in other parts of the record, it was also considered useful to combine the data for LGG from phase I and phase II, which was done here.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with High Grade Glioma.
    id
    OG000
    title
    High Grade Glioma
  2. description
    Participants with Low Grade Glioma.
    id
    OG001
    title
    Low Grade Glioma
param Type
MEDIAN
population Description
The safety evaluable population was defined as all participants who received at least one dose of study drug. Participants enrolled into phase I (Dose-Escalation) cohorts independent of their tumor type. For phase II, only one tumor type cohort was opened (LGG). As the same criteria were not used to assess response in all tumor types, the efficacy analyses were broken down by tumor type.
reporting Status
POSTED
time Frame
Baseline until death due to any cause (up to 5 years, 2 months)
title
OS for Participants With High-Grade Glioma (HGG) (Phase I) and Low-Grade Glioma (LGG) (Phase I and II)
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice