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NCT02465528 · OUTCOME

Disease Control Rate (DCR) Based on Investigator Assessments for Participants With at Least 16 Weeks of Treatment

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Baseline up to approximately 16 weeks

What was measured

The DCR is defined as the percentage of patients with complete response (CR), partial response (PR) or stable disease (SD) at 16 weeks from the start of ceritinib treatment. The assessment criteria are: Solid Tumors (RECIST 1.1., Response Evaluation Criteria in Solid Tumors); GBM (RECIST 1.1 and RANO, Response Evaluation in Neuro-Oncology); Hematologic tumors (Cheson).

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)1
Inflammatory Myofibroblastic Tumor (IMT)4
Glioblastoma (GBM)12
Any Other ALK-positive Tumor5

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Anaplastic Large Cell Lymphoma (ALCL)100.00Not reported2.5100.0Not reported
Inflammatory Myofibroblastic Tumor (IMT)75.00Not reported19.499.4Not reported
Glioblastoma (GBM)0.0Not reported0.026.5Not reported
Any Other ALK-positive Tumor40.0Not reported5.385.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.5
        upper Limit
        100.0
        value
        100.00
      2. group Id
        OG001
        lower Limit
        19.4
        upper Limit
        99.4
        value
        75.00
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        26.5
        value
        0.0
      4. group Id
        OG003
        lower Limit
        5.3
        upper Limit
        85.3
        value
        40.0
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      12
    4. group Id
      OG003
      value
      5
    units
    Participants
description
The DCR is defined as the percentage of patients with complete response (CR), partial response (PR) or stable disease (SD) at 16 weeks from the start of ceritinib treatment. The assessment criteria are: Solid Tumors (RECIST 1.1., Response Evaluation Criteria in Solid Tumors); GBM (RECIST 1.1 and RANO, Response Evaluation in Neuro-Oncology); Hematologic tumors (Cheson).
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
NUMBER
reporting Status
POSTED
time Frame
Baseline up to approximately 16 weeks
title
Disease Control Rate (DCR) Based on Investigator Assessments for Participants With at Least 16 Weeks of Treatment
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice