NCT01121588 · OUTCOME

Percentage of Participants Surviving at 6 Months and 1 Year

Studying An Investigational Drug Crizotinib (PF-02341066) In Non Non-Small Cell Lung Cancer Tumors That Are Positive For Anaplastic Lymphoma Kinase (ALK) · Source last updated 2025-01-23

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: At 6 months and 1 year after first dose

What was measured

The probability of survival at 6 months and 1 year, respectively, after the date of the first dose based on the Kaplan-Meier estimate.

Analysis population: Enrolled participants who received at least 1 dose of study treatment.

Groups in this outcome

ALCL Arm

In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.

IMT Arm

In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.

Other Tumors

In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.

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
ALCL Arm	17
IMT Arm	9
Other Tumors	18

Reported measurements

6 Months

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	76.5	Not reported	48.8	90.4	Not reported
IMT Arm	100.0	Not reported	100.0	100.0	Not reported
Other Tumors	52.9	Not reported	27.6	73.0	Not reported

1 Year

Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
ALCL Arm	70.6	Not reported	43.1	86.6	Not reported
IMT Arm	100.0	Not reported	100.0	100.0	Not reported
Other Tumors	52.9	Not reported	27.6	73.0	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
48.8
upper Limit
90.4
value
76.5
group Id
OG001
lower Limit
100.0
upper Limit
100.0
value
100.0
group Id
OG002
lower Limit
27.6
upper Limit
73.0
value
52.9
title
6 Months
categories
measurements
group Id
OG000
lower Limit
43.1
upper Limit
86.6
value
70.6
group Id
OG001
lower Limit
100.0
upper Limit
100.0
value
100.0
group Id
OG002
lower Limit
27.6
upper Limit
73.0
value
52.9
title
1 Year

denoms

counts
group Id
OG000
value
17
group Id
OG001
value
9
group Id
OG002
value
18
units
Participants

description

The probability of survival at 6 months and 1 year, respectively, after the date of the first dose based on the Kaplan-Meier estimate.

dispersion Type

95% Confidence Interval

groups

description
In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
id
OG000
title
ALCL Arm
description
In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
id
OG001
title
IMT Arm
description
In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
id
OG002
title
Other Tumors

param Type

NUMBER

population Description

Enrolled participants who received at least 1 dose of study treatment.

reporting Status

POSTED

time Frame

At 6 months and 1 year after first dose

title

Percentage of Participants Surviving at 6 Months and 1 Year

type

SECONDARY

unit Of Measure

Percentage of participants

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Preserved source evidence · Not medical advice