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NCT01283516 · OUTCOME

Number of Participants With Dose Limiting Toxicities (DLTs)

A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase · Source last updated 2019-03-15

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
33 months

What was measured

The maximum tolerated dose (MTD) was defined as the highest dose for a given schedule that was expected to cause DLTs in no more than 33% of patients during the first cycle of treatment. A patient with multiple occurrences of a DLT under one treatment is counted only once in the AE category for that treatment. MTD was determined at 750mg.

Analysis population: Dose-determining Set (DDS) consists of all patients (NSCLC and non-NSCLC) from the safety set who either meet the minimum exposure criterion and have sufficient safety evaluations or have experienced a dose limiting toxicity (DLT) during Cycle 1 (including the PK run-in period). This constitutes all evaluable patients for the determination of MTD.

Groups in this outcome

LDK378 50 mg

Participants receiving 50 mg of LDK378

LDK378 100 mg

Participants receiving 100 mg of LDK378

LDK378 200 mg

Participants receiving 200 mg of LDK378

LDK378 300 mg

Participants receiving 300 mg of LDK378

LDK378 400 mg

Participants receiving 400 mg of LDK378

LDK378 500 mg

Participants receiving 500 mg of LDK378

LDK378 600 mg

Participants receiving 600 mg of LDK378

LDK378 700 mg

Participants receiving 700 mg of LDK378

LDK378 750 mg

Participants receiving 750 mg of LDK378.

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

Analysis denominator · Participants

GroupSource count
LDK378 50 mg2
LDK378 100 mg1
LDK378 200 mg3
LDK378 300 mg3
LDK378 400 mg14
LDK378 500 mg8
LDK378 600 mg10
LDK378 700 mg5
LDK378 750 mg8

Reported measurements

Diarrhea
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LDK378 50 mg0Not reportedNot reportedNot reportedNot reported
LDK378 100 mg0Not reportedNot reportedNot reportedNot reported
LDK378 200 mg0Not reportedNot reportedNot reportedNot reported
LDK378 300 mg0Not reportedNot reportedNot reportedNot reported
LDK378 400 mg0Not reportedNot reportedNot reportedNot reported
LDK378 500 mg0Not reportedNot reportedNot reportedNot reported
LDK378 600 mg1Not reportedNot reportedNot reportedNot reported
LDK378 700 mg0Not reportedNot reportedNot reportedNot reported
LDK378 750 mg2Not reportedNot reportedNot reportedNot reported
Vomiting
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LDK378 50 mg0Not reportedNot reportedNot reportedNot reported
LDK378 100 mg0Not reportedNot reportedNot reportedNot reported
LDK378 200 mg0Not reportedNot reportedNot reportedNot reported
LDK378 300 mg0Not reportedNot reportedNot reportedNot reported
LDK378 400 mg0Not reportedNot reportedNot reportedNot reported
LDK378 500 mg0Not reportedNot reportedNot reportedNot reported
LDK378 600 mg0Not reportedNot reportedNot reportedNot reported
LDK378 700 mg0Not reportedNot reportedNot reportedNot reported
LDK378 750 mg1Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase Increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LDK378 50 mg0Not reportedNot reportedNot reportedNot reported
LDK378 100 mg0Not reportedNot reportedNot reportedNot reported
LDK378 200 mg0Not reportedNot reportedNot reportedNot reported
LDK378 300 mg0Not reportedNot reportedNot reportedNot reported
LDK378 400 mg1Not reportedNot reportedNot reportedNot reported
LDK378 500 mg0Not reportedNot reportedNot reportedNot reported
LDK378 600 mg0Not reportedNot reportedNot reportedNot reported
LDK378 700 mg0Not reportedNot reportedNot reportedNot reported
LDK378 750 mg0Not reportedNot reportedNot reportedNot reported
Transaminases Increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LDK378 50 mg0Not reportedNot reportedNot reportedNot reported
LDK378 100 mg0Not reportedNot reportedNot reportedNot reported
LDK378 200 mg0Not reportedNot reportedNot reportedNot reported
LDK378 300 mg0Not reportedNot reportedNot reportedNot reported
LDK378 400 mg1Not reportedNot reportedNot reportedNot reported
LDK378 500 mg0Not reportedNot reportedNot reportedNot reported
LDK378 600 mg0Not reportedNot reportedNot reportedNot reported
LDK378 700 mg0Not reportedNot reportedNot reportedNot reported
LDK378 750 mg0Not reportedNot reportedNot reportedNot reported
Dehydration
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LDK378 50 mg0Not reportedNot reportedNot reportedNot reported
LDK378 100 mg0Not reportedNot reportedNot reportedNot reported
LDK378 200 mg0Not reportedNot reportedNot reportedNot reported
LDK378 300 mg0Not reportedNot reportedNot reportedNot reported
LDK378 400 mg0Not reportedNot reportedNot reportedNot reported
LDK378 500 mg0Not reportedNot reportedNot reportedNot reported
LDK378 600 mg1Not reportedNot reportedNot reportedNot reported
LDK378 700 mg0Not reportedNot reportedNot reportedNot reported
LDK378 750 mg0Not reportedNot reportedNot reportedNot reported
Hypophosphataemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LDK378 50 mg0Not reportedNot reportedNot reportedNot reported
LDK378 100 mg0Not reportedNot reportedNot reportedNot reported
LDK378 200 mg0Not reportedNot reportedNot reportedNot reported
LDK378 300 mg0Not reportedNot reportedNot reportedNot reported
LDK378 400 mg1Not reportedNot reportedNot reportedNot reported
LDK378 500 mg0Not reportedNot reportedNot reportedNot reported
LDK378 600 mg0Not reportedNot reportedNot reportedNot reported
LDK378 700 mg0Not reportedNot reportedNot reportedNot reported
LDK378 750 mg0Not reportedNot reportedNot reportedNot reported
Complete source fields
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
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        2
    title
    Diarrhea
  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
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        1
    title
    Vomiting
  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
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
    title
    Alanine Aminotransferase Increased
  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
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
    title
    Transaminases Increased
  5. 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
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
    title
    Dehydration
  6. 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
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
    title
    Hypophosphataemia
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      14
    6. group Id
      OG005
      value
      8
    7. group Id
      OG006
      value
      10
    8. group Id
      OG007
      value
      5
    9. group Id
      OG008
      value
      8
    units
    Participants
description
The maximum tolerated dose (MTD) was defined as the highest dose for a given schedule that was expected to cause DLTs in no more than 33% of patients during the first cycle of treatment. A patient with multiple occurrences of a DLT under one treatment is counted only once in the AE category for that treatment. MTD was determined at 750mg.
groups
  1. description
    Participants receiving 50 mg of LDK378
    id
    OG000
    title
    LDK378 50 mg
  2. description
    Participants receiving 100 mg of LDK378
    id
    OG001
    title
    LDK378 100 mg
  3. description
    Participants receiving 200 mg of LDK378
    id
    OG002
    title
    LDK378 200 mg
  4. description
    Participants receiving 300 mg of LDK378
    id
    OG003
    title
    LDK378 300 mg
  5. description
    Participants receiving 400 mg of LDK378
    id
    OG004
    title
    LDK378 400 mg
  6. description
    Participants receiving 500 mg of LDK378
    id
    OG005
    title
    LDK378 500 mg
  7. description
    Participants receiving 600 mg of LDK378
    id
    OG006
    title
    LDK378 600 mg
  8. description
    Participants receiving 700 mg of LDK378
    id
    OG007
    title
    LDK378 700 mg
  9. description
    Participants receiving 750 mg of LDK378.
    id
    OG008
    title
    LDK378 750 mg
param Type
NUMBER
population Description
Dose-determining Set (DDS) consists of all patients (NSCLC and non-NSCLC) from the safety set who either meet the minimum exposure criterion and have sufficient safety evaluations or have experienced a dose limiting toxicity (DLT) during Cycle 1 (including the PK run-in period). This constitutes all evaluable patients for the determination of MTD.
reporting Status
POSTED
time Frame
33 months
title
Number of Participants With Dose Limiting Toxicities (DLTs)
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice