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NCT02639546 · OUTCOME

Progression-Free Survival (PFS) as Determined by the Investigator Using mINRC for Participants With Neuroblastoma (Phase I)

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
From the time of cobimetinib study drug initiation to the first documented disease progression, or death due to any cause, whichever occurs first (up to 5 years, 2 months)

What was measured

Tumor assessment was performed using mINRC for Participants with Neuroblastoma.

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. 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

Neuroblastoma

Participants with Neuroblastoma.

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

Analysis denominator · Participants

GroupSource count
Neuroblastoma1

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Neuroblastoma1.3Not reportedNANAThe confidence interval could not be calculated from the data of one participant.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The confidence interval could not be calculated from the data of one participant.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        1.3
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
description
Tumor assessment was performed using mINRC for Participants with Neuroblastoma.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with Neuroblastoma.
    id
    OG000
    title
    Neuroblastoma
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. 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
From the time of cobimetinib study drug initiation to the first documented disease progression, or death due to any cause, whichever occurs first (up to 5 years, 2 months)
title
Progression-Free Survival (PFS) as Determined by the Investigator Using mINRC for Participants With Neuroblastoma (Phase I)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice