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NCT00585195 · OUTCOME

Recommended Phase 2 Dose (RP2D) Cohort: Overall Survival (OS)

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization date to the date of death (up to 172 Months)

What was measured

OS was defined as the time from randomization to death due to any cause.

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 Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg51.4Not reported29.3NAUpper limit of 95% CI could not be estimable due to low number of participants with events.
RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg20.0Not reported13.225.7Not reported
RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg10.1Not reported7.112.9Not reported
RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mgNANot reportedNANAMedian and 95% CI could not be estimable due to low number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper limit of 95% CI could not be estimable due to low number of participants with events.
        group Id
        OG000
        lower Limit
        29.3
        upper Limit
        NA
        value
        51.4
      2. group Id
        OG001
        lower Limit
        13.2
        upper Limit
        25.7
        value
        20.0
      3. group Id
        OG002
        lower Limit
        7.1
        upper Limit
        12.9
        value
        10.1
      4. comment
        Median and 95% CI could not be estimable due to low number of participants with events.
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
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
OS was defined as the time from randomization to death due to any cause.
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
MEDIAN
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
From randomization date to the date of death (up to 172 Months)
title
Recommended Phase 2 Dose (RP2D) Cohort: Overall Survival (OS)
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice