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NCT00585195 · OUTCOME

Probability of Participant Survival at Month 12

A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer · Source last updated 2023-02-08

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

Measure
NUMBER
Unit
probability of participants survival
Interval / dispersion
95% Confidence Interval
Time frame
Month 12

What was measured

Probability of survival was defined as the probability of being alive at Month 12.

Analysis population: SA set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data was planned to be analyzed for reported arms only.

Groups in this outcome

RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg

Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 105 cycles (each cycle 28 days).

RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg

Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 55 cycles (each cycle 28 days).

RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg

Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 days).

RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg

Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).

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

Analysis denominator · Participants

GroupSource count
RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg53
RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg85
RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg41
RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg119

Reported measurements

Source class 1
Values in probability of participants survival · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg78.8Not reported65.087.7Not reported
RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg66.0Not reported54.075.5Not reported
RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg37.1Not reported22.451.8Not reported
RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg80.5Not reported70.987.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        65.0
        upper Limit
        87.7
        value
        78.8
      2. group Id
        OG001
        lower Limit
        54.0
        upper Limit
        75.5
        value
        66.0
      3. group Id
        OG002
        lower Limit
        22.4
        upper Limit
        51.8
        value
        37.1
      4. group Id
        OG003
        lower Limit
        70.9
        upper Limit
        87.2
        value
        80.5
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    2. group Id
      OG001
      value
      85
    3. group Id
      OG002
      value
      41
    4. group Id
      OG003
      value
      119
    units
    Participants
description
Probability of survival was defined as the probability of being alive at Month 12.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 105 cycles (each cycle 28 days).
    id
    OG000
    title
    RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg
  2. description
    Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 55 cycles (each cycle 28 days).
    id
    OG001
    title
    RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg
  3. description
    Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet orally twice daily (BID) with or without food for up to 101 cycles (each cycle 28 days).
    id
    OG002
    title
    RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg
  4. description
    Participants received Crizotinib 250 mg (2 capsules/tablet of 100 mg each + 1 capsule/tablet of 50 mg) capsule/tablet twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).
    id
    OG003
    title
    RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg
param Type
NUMBER
population Description
SA set included all enrolled participants who received at least one dose of Crizotinib on Cycle 1 Day 1. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data was planned to be analyzed for reported arms only.
reporting Status
POSTED
time Frame
Month 12
title
Probability of Participant Survival at Month 12
type
PRIMARY
unit Of Measure
probability of participants survival

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

Preserved source evidence · Not medical advice