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NCT02465528 · OUTCOME

Progression Free Survival (PFS) Per Investigator Assessments

Ceritinib Rare Indications Study in ALK+ Tumors · Source last updated 2019-12-27

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

Measure
MEDIAN
Unit
weeks
Interval / dispersion
95% Confidence Interval
Time frame
Baseline, every 8 weeks until disease progression or death from any cause, assessed for up to approximately 84 weeks

What was measured

PFS is defined as the time from the date of first dose of ceritinib to the date of first documented disease progression or death from any cause

Analysis population: no participants met definition of PFS

Groups in this outcome

Anaplastic Large Cell Lymphoma (ALCL)

Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive

Inflammatory Myofibroblastic Tumor (IMT)

Patients diagnosed with IMT with a confirmed translocation involving the ALK gene

Glioblastoma (GBM)

Patients with GBM with a translocation involving the ALK gene

Any Other ALK-positive Tumor

Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).

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

Analysis denominator · Participants

GroupSource count
Anaplastic Large Cell Lymphoma (ALCL)0
Inflammatory Myofibroblastic Tumor (IMT)2
Glioblastoma (GBM)9
Any Other ALK-positive Tumor5

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Inflammatory Myofibroblastic Tumor (IMT)NANot reported3.7NAMedian and upper CI were not estimable
Glioblastoma (GBM)1.7Not reported1.12.7Not reported
Any Other ALK-positive Tumor1.7Not reported1.65.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and upper CI were not estimable
        group Id
        OG001
        lower Limit
        3.7
        upper Limit
        NA
        value
        NA
      2. group Id
        OG002
        lower Limit
        1.1
        upper Limit
        2.7
        value
        1.7
      3. group Id
        OG003
        lower Limit
        1.6
        upper Limit
        5.1
        value
        1.7
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      9
    4. group Id
      OG003
      value
      5
    units
    Participants
description
PFS is defined as the time from the date of first dose of ceritinib to the date of first documented disease progression or death from any cause
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with a diagnosis of ALCL histologically or cytologically confirmed to be ALK-positive
    id
    OG000
    title
    Anaplastic Large Cell Lymphoma (ALCL)
  2. description
    Patients diagnosed with IMT with a confirmed translocation involving the ALK gene
    id
    OG001
    title
    Inflammatory Myofibroblastic Tumor (IMT)
  3. description
    Patients with GBM with a translocation involving the ALK gene
    id
    OG002
    title
    Glioblastoma (GBM)
  4. description
    Patients with any other ALK-positive tumor. Patients in this arm included adenocarcinoma (n= 2), sarcoma (1) and other (2).
    id
    OG003
    title
    Any Other ALK-positive Tumor
param Type
MEDIAN
population Description
no participants met definition of PFS
reporting Status
POSTED
time Frame
Baseline, every 8 weeks until disease progression or death from any cause, assessed for up to approximately 84 weeks
title
Progression Free Survival (PFS) Per Investigator Assessments
type
SECONDARY
unit Of Measure
weeks

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

Preserved source evidence · Not medical advice