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NCT00585195 · OUTCOME

Recommended Phase 2 Dose (RP2D) Cohort: Percentage of Participants With Disease Control at Week 16

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
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Week 16

What was measured

Disease control was defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) per RECIST version 1.0 (RECIST1.1 for ALK-negative NSCLC cohort 1 and ALK-negative NSCLC cohort 2). PR: At least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum), without progression of non-target lesions and no appearance of new lesions indicated partial response. CR: Disappearance of all target and non-target lesions, normalization of tumor marker levels, and no appearance of new lesions indicated complete response. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Analysis population: Response-evaluable population was defined as all participants in the SA set who had an adequate baseline disease assessment and had met 1 of the following 2 criteria: a) Had at least one post-baseline disease assessment b) withdrew from the trial or experienced progression/death at any time on study. 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: 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).

RP2D Cohort: ALK-Negative Cohort 2, 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 BID with or without food for up to 70 cycles (each cycle 21 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: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg116
RP2D Cohort: ALK-Negative Cohort 2, NSCLC: Crizotinib 250 mg18

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg79.2Not reported65.989.2Not reported
RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg51.8Not reported40.762.7Not reported
RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg67.2Not reported57.975.7Not reported
RP2D Cohort: ALK-Negative Cohort 2, NSCLC: Crizotinib 250 mg42.9Not reported21.866.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        65.9
        upper Limit
        89.2
        value
        79.2
      2. group Id
        OG001
        lower Limit
        40.7
        upper Limit
        62.7
        value
        51.8
      3. group Id
        OG002
        lower Limit
        57.9
        upper Limit
        75.7
        value
        67.2
      4. group Id
        OG003
        lower Limit
        21.8
        upper Limit
        66.0
        value
        42.9
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    2. group Id
      OG001
      value
      85
    3. group Id
      OG002
      value
      116
    4. group Id
      OG003
      value
      18
    units
    Participants
description
Disease control was defined as the percentage of participants with a confirmed CR, PR, or stable disease (SD) per RECIST version 1.0 (RECIST1.1 for ALK-negative NSCLC cohort 1 and ALK-negative NSCLC cohort 2). PR: At least a 30% decrease in the sum of the longest diameters of target lesions (taking as reference the baseline sum), without progression of non-target lesions and no appearance of new lesions indicated partial response. CR: Disappearance of all target and non-target lesions, normalization of tumor marker levels, and no appearance of new lesions indicated complete response. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
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 twice daily (BID) with or without food for up to 133 cycles (each cycle 28 days).
    id
    OG002
    title
    RP2D Cohort: ALK-Positive Cohort, 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 orally BID with or without food for up to 70 cycles (each cycle 21 days).
    id
    OG003
    title
    RP2D Cohort: ALK-Negative Cohort 2, NSCLC: Crizotinib 250 mg
param Type
NUMBER
population Description
Response-evaluable population was defined as all participants in the SA set who had an adequate baseline disease assessment and had met 1 of the following 2 criteria: a) Had at least one post-baseline disease assessment b) withdrew from the trial or experienced progression/death at any time on study. 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
Week 16
title
Recommended Phase 2 Dose (RP2D) Cohort: Percentage of Participants With Disease Control at Week 16
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice