NCT00585195 · OUTCOME

Recommended Phase 2 Dose (RP2D) Cohort: Time to Response (TTR)

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 dose until first documented response of PR or CR (up to 172 months)

What was measured

TTR: time between first dose until first documented response of PR or CR. 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.

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

Group	Source count
RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg	38
RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg	33
RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg	12
RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg	71

Reported measurements

Source class 1

Values in Weeks · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
RP2D Cohort: ROS1-Positive NSCLC: Crizotinib 250 mg	7.9	Not reported	4.3	103.6	Not reported
RP2D Cohort: MET Exon 14 Alterations NSCLC: Crizotinib 250 mg	7.6	Not reported	3.7	47.3	Not reported
RP2D Cohort: MET Amplification NSCLC: Crizotinib 250 mg	8.0	Not reported	7.1	23.6	Not reported
RP2D Cohort: ALK-Positive Cohort, NSCLC: Crizotinib 250 mg	7.7	Not reported	4.3	39.6	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
4.3
upper Limit
103.6
value
7.9
group Id
OG001
lower Limit
3.7
upper Limit
47.3
value
7.6
group Id
OG002
lower Limit
7.1
upper Limit
23.6
value
8.0
group Id
OG003
lower Limit
4.3
upper Limit
39.6
value
7.7

denoms

counts
group Id
OG000
value
38
group Id
OG001
value
33
group Id
OG002
value
12
group Id
OG003
value
71
units
Participants

description

dispersion Type

Full Range

groups

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
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
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
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 dose until first documented response of PR or CR (up to 172 months)

title

Recommended Phase 2 Dose (RP2D) Cohort: Time to Response (TTR)

type

PRIMARY

unit Of Measure

Weeks

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Preserved source evidence · Not medical advice