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NCT01154140 · OUTCOME

Percentage of Participants For Each Anaplastic Lymphoma Kinase (ALK) Gene Fusion Variants

A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung · Source last updated 2017-11-06

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
Not reported
Time frame
28 days prior to day 1 of study treatment

What was measured

The Response Genetics, Inc. Echinoderm Microtubule Associated Protein Like 4 (EML4) ALK reverse transcriptase polymerase chain reaction (RT PCR) gene fusion test was used for the analysis of tissue samples for the ALK gene fusion variants (either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements \[V1, V2, V3a, V3b,V3a/b, V4, V5a, V6, V7\]). Percentage of participants who tested positive for ALK gene fusion variants were reported in this outcome measure.

Analysis population: The ALK variant evaluable population included participants from the FA population who had a result from ALK gene fusion variant testing of either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements (V1, V2, V3a, V3b, V3a/b, V4, V5a, V6, and V7).

Groups in this outcome

Crizotinib

Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.

Chemotherapy

Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.

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

Analysis denominator · Participants

GroupSource count
Crizotinib70
Chemotherapy78

Reported measurements

V1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib27.1Not reportedNot reportedNot reportedNot reported
Chemotherapy25.6Not reportedNot reportedNot reportedNot reported
V2
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib7.1Not reportedNot reportedNot reportedNot reported
Chemotherapy7.7Not reportedNot reportedNot reportedNot reported
V3a
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib1.4Not reportedNot reportedNot reportedNot reported
Chemotherapy1.3Not reportedNot reportedNot reportedNot reported
V3a/b
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib4.3Not reportedNot reportedNot reportedNot reported
Chemotherapy6.4Not reportedNot reportedNot reportedNot reported
No rearrangement
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib60.0Not reportedNot reportedNot reportedNot reported
Chemotherapy59.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        27.1
      2. group Id
        OG001
        value
        25.6
    title
    V1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        7.1
      2. group Id
        OG001
        value
        7.7
    title
    V2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1.4
      2. group Id
        OG001
        value
        1.3
    title
    V3a
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4.3
      2. group Id
        OG001
        value
        6.4
    title
    V3a/b
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        60.0
      2. group Id
        OG001
        value
        59.0
    title
    No rearrangement
denoms
  1. counts
    1. group Id
      OG000
      value
      70
    2. group Id
      OG001
      value
      78
    units
    Participants
description
The Response Genetics, Inc. Echinoderm Microtubule Associated Protein Like 4 (EML4) ALK reverse transcriptase polymerase chain reaction (RT PCR) gene fusion test was used for the analysis of tissue samples for the ALK gene fusion variants (either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements \[V1, V2, V3a, V3b,V3a/b, V4, V5a, V6, V7\]). Percentage of participants who tested positive for ALK gene fusion variants were reported in this outcome measure.
groups
  1. description
    Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
    id
    OG000
    title
    Crizotinib
  2. description
    Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.
    id
    OG001
    title
    Chemotherapy
param Type
NUMBER
population Description
The ALK variant evaluable population included participants from the FA population who had a result from ALK gene fusion variant testing of either no rearrangement, or 1 of 9 results reflecting 8 specific rearrangements (V1, V2, V3a, V3b, V3a/b, V4, V5a, V6, and V7).
reporting Status
POSTED
time Frame
28 days prior to day 1 of study treatment
title
Percentage of Participants For Each Anaplastic Lymphoma Kinase (ALK) Gene Fusion Variants
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice