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NCT00585195 · OUTCOME

Recommended Phase 2 Dose (RP2D) Cohort: Percentage of Participants With Objective Response (OR)

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
Baseline up to 172 months

What was measured

ORR was defined as participants with a best overall response of complete response (CR) or partial response (PR) divided by the total number of evaluable participants per RECIST version 1.0 (RECIST1.1 for ALK-negative NSCLC cohort 1 and ALK-negative NSCLC cohort 2). CR: Disappearance of all target and non-target lesions, normalization of tumor marker levels, and no appearance of new lesions indicated complete response. 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.

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: 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-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).

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: Enriched Other: 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 54 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 mg65
RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg38
RP2D Cohort: ALK-Negative Cohort 2, NSCLC: Crizotinib 250 mg18
RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg116
RP2D Cohort: Enriched Other: Crizotinib 250 mg66

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg71.7Not reported57.783.2Not reported
RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg32.3Not reported21.245.1Not reported
RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg31.6Not reported17.548.7Not reported
RP2D Cohort: ALK-Negative Cohort 2, NSCLC: Crizotinib 250 mg19.0Not reported5.441.9Not reported
RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg61.2Not reported51.770.1Not reported
RP2D Cohort: Enriched Other: Crizotinib 250 mg8.3Not reported0.238.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        57.7
        upper Limit
        83.2
        value
        71.7
      2. group Id
        OG001
        lower Limit
        21.2
        upper Limit
        45.1
        value
        32.3
      3. group Id
        OG002
        lower Limit
        17.5
        upper Limit
        48.7
        value
        31.6
      4. group Id
        OG003
        lower Limit
        5.4
        upper Limit
        41.9
        value
        19.0
      5. group Id
        OG004
        lower Limit
        51.7
        upper Limit
        70.1
        value
        61.2
      6. group Id
        OG005
        lower Limit
        0.2
        upper Limit
        38.5
        value
        8.3
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    2. group Id
      OG001
      value
      65
    3. group Id
      OG002
      value
      38
    4. group Id
      OG003
      value
      18
    5. group Id
      OG004
      value
      116
    6. group Id
      OG005
      value
      66
    units
    Participants
description
ORR was defined as participants with a best overall response of complete response (CR) or partial response (PR) divided by the total number of evaluable participants per RECIST version 1.0 (RECIST1.1 for ALK-negative NSCLC cohort 1 and ALK-negative NSCLC cohort 2). CR: Disappearance of all target and non-target lesions, normalization of tumor marker levels, and no appearance of new lesions indicated complete response. 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.
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 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
  5. 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
    OG004
    title
    RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg
  6. 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 54 cycles (each cycle 28 days).
    id
    OG005
    title
    RP2D Cohort: Enriched Other: 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
Baseline up to 172 months
title
Recommended Phase 2 Dose (RP2D) Cohort: Percentage of Participants With Objective Response (OR)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice