Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00585195 · OUTCOME

Recommended Phase 2 Dose (RP2D) Cohort: Duration of Response (DOR)

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
Weeks
Interval / dispersion
Full Range
Time frame
From first documentation of response to date of PD or death due to any cause (up to 172 months)

What was measured

Duration of response (DoR) was the time from first documentation of PR or CR to date of first documentation of progressive disease (PD) or death due to any cause. 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. PD: \>=20% increase in the sum of the longest diameter of target lesions taking as references the smallest sum longest diameter recorded since the treatment started, unequivocal progression of existing non-target lesions, or the appearance of 1 or more new lesions.

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 who were objective responders. 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 mg38
RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg33
RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg12
RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg71

Reported measurements

Source class 1
Values in Weeks · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg14.5Not reported2.845.4Not reported
RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg6.8Not reported2.813.4Not reported
RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg5.2Not reported3.812.2Not reported
RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg26.2Not reported8.172.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.8
        upper Limit
        45.4
        value
        14.5
      2. group Id
        OG001
        lower Limit
        2.8
        upper Limit
        13.4
        value
        6.8
      3. group Id
        OG002
        lower Limit
        3.8
        upper Limit
        12.2
        value
        5.2
      4. group Id
        OG003
        lower Limit
        8.1
        upper Limit
        72.9
        value
        26.2
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    2. group Id
      OG001
      value
      33
    3. group Id
      OG002
      value
      12
    4. group Id
      OG003
      value
      71
    units
    Participants
description
Duration of response (DoR) was the time from first documentation of PR or CR to date of first documentation of progressive disease (PD) or death due to any cause. 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. PD: \>=20% increase in the sum of the longest diameter of target lesions taking as references the smallest sum longest diameter recorded since the treatment started, unequivocal progression of existing non-target lesions, or the appearance of 1 or more new lesions.
dispersion Type
Full Range
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
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 who were objective responders. Data was planned to be analyzed for reported arms only.
reporting Status
POSTED
time Frame
From first documentation of response to date of PD or death due to any cause (up to 172 months)
title
Recommended Phase 2 Dose (RP2D) Cohort: Duration of Response (DOR)
type
PRIMARY
unit Of Measure
Weeks

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

Preserved source evidence · Not medical advice