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NCT01121588 · OUTCOME

Number of Participants With ALK Genetic Events

Studying An Investigational Drug Crizotinib (PF-02341066) In Non Non-Small Cell Lung Cancer Tumors That Are Positive For Anaplastic Lymphoma Kinase (ALK) · Source last updated 2025-01-23

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From Screening 28 Days Prior to Dosing Up to End of Treatment/Withdrawal (Maximum Up to Approximately 11 Years)

What was measured

Number of participants with ALK translocation/fusion, amplification, mutation and overexpression at baseline assessed by technologies including fluorescence in-situ hybridization (FISH), immunohistochemistry (IHC), quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), ALK Fusion partners assessed by FISH or PCR; ALK gene amplification assessed by FISH or array Comparative Genomic Hybridization (aCGH), ALK Mutation assessed by PCR or direct sequencing were reported.

Analysis population: The analysis planned to include all participant who had at least one dose of study treatment and at least one data of molecular profiling. Number Analyzed = participants who were enrolled and evaluable for this OM that had ALK genetic events at baseline.

Groups in this outcome

ALCL Arm

In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.

IMT Arm

In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.

Other Tumors

In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.

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

Analysis denominator · Participants

GroupSource count
ALCL Arm17
IMT Arm9
Other Tumors18

Reported measurements

ALK FISH
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ALCL Arm2Not reportedNot reportedNot reportedNot reported
IMT Arm9Not reportedNot reportedNot reportedNot reported
Other Tumors12Not reportedNot reportedNot reportedNot reported
ALK Fusion Partner
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ALCL Arm1Not reportedNot reportedNot reportedNot reported
IMT Arm1Not reportedNot reportedNot reportedNot reported
Other Tumors2Not reportedNot reportedNot reportedNot reported
ALK RT-PCR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ALCL Arm4Not reportedNot reportedNot reportedNot reported
IMT Arm0Not reportedNot reportedNot reportedNot reported
Other Tumors2Not reportedNot reportedNot reportedNot reported
ALK Gene Amplification
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ALCL Arm0Not reportedNot reportedNot reportedNot reported
IMT Arm0Not reportedNot reportedNot reportedNot reported
Other Tumors3Not reportedNot reportedNot reportedNot reported
ALK IHC
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ALCL Arm15Not reportedNot reportedNot reportedNot reported
IMT Arm1Not reportedNot reportedNot reportedNot reported
Other Tumors3Not reportedNot reportedNot reportedNot reported
ALK Mutation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ALCL Arm0Not reportedNot reportedNot reportedNot reported
IMT Arm0Not reportedNot reportedNot reportedNot reported
Other Tumors4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        12
    title
    ALK FISH
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
    title
    ALK Fusion Partner
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
    title
    ALK RT-PCR
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
    title
    ALK Gene Amplification
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
    title
    ALK IHC
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        4
    title
    ALK Mutation
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      18
    units
    Participants
description
Number of participants with ALK translocation/fusion, amplification, mutation and overexpression at baseline assessed by technologies including fluorescence in-situ hybridization (FISH), immunohistochemistry (IHC), quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), ALK Fusion partners assessed by FISH or PCR; ALK gene amplification assessed by FISH or array Comparative Genomic Hybridization (aCGH), ALK Mutation assessed by PCR or direct sequencing were reported.
groups
  1. description
    In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
    id
    OG000
    title
    ALCL Arm
  2. description
    In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
    id
    OG001
    title
    IMT Arm
  3. description
    In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
    id
    OG002
    title
    Other Tumors
param Type
COUNT_OF_PARTICIPANTS
population Description
The analysis planned to include all participant who had at least one dose of study treatment and at least one data of molecular profiling. Number Analyzed = participants who were enrolled and evaluable for this OM that had ALK genetic events at baseline.
reporting Status
POSTED
time Frame
From Screening 28 Days Prior to Dosing Up to End of Treatment/Withdrawal (Maximum Up to Approximately 11 Years)
title
Number of Participants With ALK Genetic Events
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice