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NCT02465528 · OUTCOME

Duration of Response (DOR) Per Investigator Assessment

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 end of treatment, whichever came first, assessed up to approximately 84 weeks

What was measured

DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause

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

Glioblastomia (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)1
Inflammatory Myofibroblastic Tumor (IMT)3
Glioblastomia (GBM)12
Any Other ALK-positive Tumor5

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Anaplastic Large Cell Lymphoma (ALCL)NANot reportedNANAMedian was not reached for DOR therefore Confidence Interval was not estimable
Inflammatory Myofibroblastic Tumor (IMT)NANot reported3.0NAMedian was not reached for DOR
Glioblastomia (GBM)NANot reportedNANANo participants experienced CR or PR for this cohort
Any Other ALK-positive TumorNANot reportedNANANo participants experienced CR or PR for this cohort
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median was not reached for DOR therefore Confidence Interval was not estimable
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Median was not reached for DOR
        group Id
        OG001
        lower Limit
        3.0
        upper Limit
        NA
        value
        NA
      3. comment
        No participants experienced CR or PR for this cohort
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. comment
        No participants experienced CR or PR for this cohort
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      12
    4. group Id
      OG003
      value
      5
    units
    Participants
description
DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to 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
    Glioblastomia (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
reporting Status
POSTED
time Frame
Baseline, every 8 weeks until disease progression or end of treatment, whichever came first, assessed up to approximately 84 weeks
title
Duration of Response (DOR) Per Investigator Assessment
type
SECONDARY
unit Of Measure
weeks

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

Preserved source evidence · Not medical advice