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NCT01742286 · OUTCOME

Incidence Rate of Dose Limiting Toxicities (DLTs) Occurring During First Cycle of Treatment

Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK) · Source last updated 2020-06-09

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
up to day 21 after the patient's first dose; cycle = within the first 21 days of patient's first dose

What was measured

A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant therapies that occurs within the first 21 days of treatment with LDK378 and meets a specified defined criteria. A participant with multiple occurrences of DLTs under one treatment is counted only once in the Adverse Event category for that treatment. A participant with multiple DLTs within a primary system organ class is counted only once in the total row.

Analysis population: The dose determining analysis set (DDS) consisted of all patients from the Safety set who either met the minimum exposure criterion and had sufficient safety evaluations or discontinued earlier due to DLT in the escalation phase.

Groups in this outcome

Fasted: Ceritinib 300 mg/m2

Participants in the fasted group who took 300 mg of ceritinib

Fasted: Ceritinib 450 mg/m2

Participants in the fasted group who took 450 mg of ceritinib

Fasted: Ceritinib 510 mg/m2

Participants in the fasted group who took 510 mg of ceritinib

Fasted: Ceritinib 560 mg/m2

Participants in the fasted group who took 560 mg of ceritinib

Fed: Ceritinib 320 mg/m2

Participants in the fed group who took 320 mg of ceritinib

Fed: Ceritinib 400 mg/m2

Participants in the fed group who took 400 mg of ceritinib

Fed: Ceritinib 500 mg/m2

Participants in the fed group who took 500 mg of ceritinib

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

Analysis denominator · Participants

GroupSource count
Fasted: Ceritinib 300 mg/m24
Fasted: Ceritinib 450 mg/m212
Fasted: Ceritinib 510 mg/m26
Fasted: Ceritinib 560 mg/m22
Fed: Ceritinib 320 mg/m24
Fed: Ceritinib 400 mg/m24
Fed: Ceritinib 500 mg/m25

Reported measurements

Investigations: Alanine aminotransferase incr.
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fasted: Ceritinib 300 mg/m20Not reportedNot reportedNot reportedNot reported
Fasted: Ceritinib 450 mg/m20Not reportedNot reportedNot reportedNot reported
Fasted: Ceritinib 510 mg/m20Not reportedNot reportedNot reportedNot reported
Fasted: Ceritinib 560 mg/m21Not reportedNot reportedNot reportedNot reported
Fed: Ceritinib 320 mg/m20Not reportedNot reportedNot reportedNot reported
Fed: Ceritinib 400 mg/m21Not reportedNot reportedNot reportedNot reported
Fed: Ceritinib 500 mg/m20Not reportedNot reportedNot reportedNot reported
Gastrointestinal disorders: abdominal pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fasted: Ceritinib 300 mg/m20Not reportedNot reportedNot reportedNot reported
Fasted: Ceritinib 450 mg/m20Not reportedNot reportedNot reportedNot reported
Fasted: Ceritinib 510 mg/m20Not reportedNot reportedNot reportedNot reported
Fasted: Ceritinib 560 mg/m21Not reportedNot reportedNot reportedNot reported
Fed: Ceritinib 320 mg/m20Not reportedNot reportedNot reportedNot reported
Fed: Ceritinib 400 mg/m20Not reportedNot reportedNot reportedNot reported
Fed: Ceritinib 500 mg/m20Not reportedNot reportedNot reportedNot reported
Gastrointestinal disorders: Influenza
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fasted: Ceritinib 300 mg/m20Not reportedNot reportedNot reportedNot reported
Fasted: Ceritinib 450 mg/m20Not reportedNot reportedNot reportedNot reported
Fasted: Ceritinib 510 mg/m20Not reportedNot reportedNot reportedNot reported
Fasted: Ceritinib 560 mg/m20Not reportedNot reportedNot reportedNot reported
Fed: Ceritinib 320 mg/m20Not reportedNot reportedNot reportedNot reported
Fed: Ceritinib 400 mg/m20Not reportedNot reportedNot reportedNot reported
Fed: Ceritinib 500 mg/m21Not reportedNot reportedNot reportedNot reported
Total DLTs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fasted: Ceritinib 300 mg/m20Not reportedNot reportedNot reportedNot reported
Fasted: Ceritinib 450 mg/m20Not reportedNot reportedNot reportedNot reported
Fasted: Ceritinib 510 mg/m20Not reportedNot reportedNot reportedNot reported
Fasted: Ceritinib 560 mg/m22Not reportedNot reportedNot reportedNot reported
Fed: Ceritinib 320 mg/m20Not reportedNot reportedNot reportedNot reported
Fed: Ceritinib 400 mg/m21Not reportedNot reportedNot reportedNot reported
Fed: Ceritinib 500 mg/m21Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    non Inferiority Type
    OTHER
    param Type
    MTD/RDE
    param Value
    510
  2. group Ids
    1. OG004
    2. OG005
    3. OG006
    non Inferiority Type
    OTHER
    param Type
    MTD/RDE
    param Value
    500
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    non Inferiority Type
    OTHER
    param Type
    MTD/RDE
    param Value
    510
  2. group Ids
    1. OG004
    2. OG005
    3. OG006
    non Inferiority Type
    OTHER
    param Type
    MTD/RDE
    param Value
    500
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
    title
    Investigations: Alanine aminotransferase incr.
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
    title
    Gastrointestinal disorders: abdominal pain
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        1
    title
    Gastrointestinal disorders: Influenza
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        1
    title
    Total DLTs
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      4
    7. group Id
      OG006
      value
      5
    units
    Participants
description
A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant therapies that occurs within the first 21 days of treatment with LDK378 and meets a specified defined criteria. A participant with multiple occurrences of DLTs under one treatment is counted only once in the Adverse Event category for that treatment. A participant with multiple DLTs within a primary system organ class is counted only once in the total row.
groups
  1. description
    Participants in the fasted group who took 300 mg of ceritinib
    id
    OG000
    title
    Fasted: Ceritinib 300 mg/m2
  2. description
    Participants in the fasted group who took 450 mg of ceritinib
    id
    OG001
    title
    Fasted: Ceritinib 450 mg/m2
  3. description
    Participants in the fasted group who took 510 mg of ceritinib
    id
    OG002
    title
    Fasted: Ceritinib 510 mg/m2
  4. description
    Participants in the fasted group who took 560 mg of ceritinib
    id
    OG003
    title
    Fasted: Ceritinib 560 mg/m2
  5. description
    Participants in the fed group who took 320 mg of ceritinib
    id
    OG004
    title
    Fed: Ceritinib 320 mg/m2
  6. description
    Participants in the fed group who took 400 mg of ceritinib
    id
    OG005
    title
    Fed: Ceritinib 400 mg/m2
  7. description
    Participants in the fed group who took 500 mg of ceritinib
    id
    OG006
    title
    Fed: Ceritinib 500 mg/m2
param Type
NUMBER
population Description
The dose determining analysis set (DDS) consisted of all patients from the Safety set who either met the minimum exposure criterion and had sufficient safety evaluations or discontinued earlier due to DLT in the escalation phase.
reporting Status
POSTED
time Frame
up to day 21 after the patient's first dose; cycle = within the first 21 days of patient's first dose
title
Incidence Rate of Dose Limiting Toxicities (DLTs) Occurring During First Cycle of Treatment
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice