NCT02393248 · OUTCOME

Parts 1 and 2: Cmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)

Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101) · Source last updated 2023-01-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: ng/mL
Interval / dispersion: Standard Deviation
Time frame: Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

What was measured

Cmax was defined as the maximum observed plasma concentration.

Analysis population: PK/PD Population. Only participants with available data were analyzed.

Groups in this outcome

Part 1: Intermittent Pemigatinib 1 mg QD

Participants self-administered oral pemigatinib 1 milligram (mg) once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Part 1: Intermittent Pemigatinib 2 mg QD

Participants self-administered oral pemigatinib 2 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Part 1: Intermittent Pemigatinib 4 mg QD

Participants self-administered oral pemigatinib 4 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Part 1: Intermittent Pemigatinib 6 mg QD

Participants self-administered oral pemigatinib 6 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.

Parts 1 and 2: Intermittent/Continuous Pemigatinib 9 mg QD

Participants self-administered intermittent or continuous oral pemigatinib 9 mg QD in either Part 1 or Part 2. Intermittent dosing: participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in either Part 1 or Part 2. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Continuous dosing: participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.

Parts 1 and 2: Intermittent/Continuous Pemigatinib 13.5 mg QD

Participants self-administered intermittent or continuous oral pemigatinib 13.5 mg QD in either Part 1 or Part 2. Intermittent dosing: participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in either Part 1 or Part 2. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Continuous dosing: participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.

Parts 1 and 2: Intermittent/Continuous Pemigatinib 20 mg QD

Participants self-administered intermittent or continuous oral pemigatinib 20 mg QD in either Part 1 or Part 2. Intermittent dosing: participants self-administered oral pemigatinib 20 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Continuous dosing: participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.

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
Part 1: Intermittent Pemigatinib 1 mg QD	1
Part 1: Intermittent Pemigatinib 2 mg QD	1
Part 1: Intermittent Pemigatinib 4 mg QD	1
Part 1: Intermittent Pemigatinib 6 mg QD	4
Parts 1 and 2: Intermittent/Continuous Pemigatinib 9 mg QD	18
Parts 1 and 2: Intermittent/Continuous Pemigatinib 13.5 mg QD	57
Parts 1 and 2: Intermittent/Continuous Pemigatinib 20 mg QD	13

Reported measurements

Source class 1

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 1: Intermittent Pemigatinib 1 mg QD	26.2	NA	Not reported	Not reported	A standard deviation was not calculated for a single participant.
Part 1: Intermittent Pemigatinib 2 mg QD	22.9	NA	Not reported	Not reported	A standard deviation was not calculated for a single participant.
Part 1: Intermittent Pemigatinib 4 mg QD	103	NA	Not reported	Not reported	A standard deviation was not calculated for a single participant.
Part 1: Intermittent Pemigatinib 6 mg QD	86.1	38.0	Not reported	Not reported	Not reported
Parts 1 and 2: Intermittent/Continuous Pemigatinib 9 mg QD	196	123	Not reported	Not reported	Not reported
Parts 1 and 2: Intermittent/Continuous Pemigatinib 13.5 mg QD	271	151	Not reported	Not reported	Not reported
Parts 1 and 2: Intermittent/Continuous Pemigatinib 20 mg QD	449	172	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

group Ids
OG003
OG004
non Inferiority Type
SUPERIORITY
p Value
0.2841
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
statistical Method
ANOVA
group Ids
OG003
OG005
non Inferiority Type
SUPERIORITY
p Value
0.3042
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
statistical Method
ANOVA
group Ids
OG003
OG006
non Inferiority Type
SUPERIORITY
p Value
0.1259
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
statistical Method
ANOVA
group Ids
OG004
OG005
non Inferiority Type
SUPERIORITY
p Value
0.8214
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
statistical Method
ANOVA
group Ids
OG004
OG006
non Inferiority Type
SUPERIORITY
p Value
0.4315
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
statistical Method
ANOVA
group Ids
OG005
OG006
non Inferiority Type
SUPERIORITY
p Value
0.2595
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
statistical Method
ANOVA

Complete source fields

analyses

group Ids
OG003
OG004
non Inferiority Type
SUPERIORITY
p Value
0.2841
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
statistical Method
ANOVA
group Ids
OG003
OG005
non Inferiority Type
SUPERIORITY
p Value
0.3042
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
statistical Method
ANOVA
group Ids
OG003
OG006
non Inferiority Type
SUPERIORITY
p Value
0.1259
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
statistical Method
ANOVA
group Ids
OG004
OG005
non Inferiority Type
SUPERIORITY
p Value
0.8214
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
statistical Method
ANOVA
group Ids
OG004
OG006
non Inferiority Type
SUPERIORITY
p Value
0.4315
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
statistical Method
ANOVA
group Ids
OG005
OG006
non Inferiority Type
SUPERIORITY
p Value
0.2595
statistical Comment
1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
statistical Method
ANOVA

classes

categories
measurements
comment
A standard deviation was not calculated for a single participant.
group Id
OG000
spread
NA
value
26.2
comment
A standard deviation was not calculated for a single participant.
group Id
OG001
spread
NA
value
22.9
comment
A standard deviation was not calculated for a single participant.
group Id
OG002
spread
NA
value
103
group Id
OG003
spread
38.0
value
86.1
group Id
OG004
spread
123
value
196
group Id
OG005
spread
151
value
271
group Id
OG006
spread
172
value
449

denoms

counts
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
4
group Id
OG004
value
18
group Id
OG005
value
57
group Id
OG006
value
13
units
Participants

description

Cmax was defined as the maximum observed plasma concentration.

dispersion Type

Standard Deviation

groups

description
Participants self-administered oral pemigatinib 1 milligram (mg) once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
id
OG000
title
Part 1: Intermittent Pemigatinib 1 mg QD
description
Participants self-administered oral pemigatinib 2 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
id
OG001
title
Part 1: Intermittent Pemigatinib 2 mg QD
description
Participants self-administered oral pemigatinib 4 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
id
OG002
title
Part 1: Intermittent Pemigatinib 4 mg QD
description
Participants self-administered oral pemigatinib 6 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
id
OG003
title
Part 1: Intermittent Pemigatinib 6 mg QD
description
Participants self-administered intermittent or continuous oral pemigatinib 9 mg QD in either Part 1 or Part 2. Intermittent dosing: participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in either Part 1 or Part 2. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Continuous dosing: participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.
id
OG004
title
Parts 1 and 2: Intermittent/Continuous Pemigatinib 9 mg QD
description
Participants self-administered intermittent or continuous oral pemigatinib 13.5 mg QD in either Part 1 or Part 2. Intermittent dosing: participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in either Part 1 or Part 2. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Continuous dosing: participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.
id
OG005
title
Parts 1 and 2: Intermittent/Continuous Pemigatinib 13.5 mg QD
description
Participants self-administered intermittent or continuous oral pemigatinib 20 mg QD in either Part 1 or Part 2. Intermittent dosing: participants self-administered oral pemigatinib 20 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. Continuous dosing: participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.
id
OG006
title
Parts 1 and 2: Intermittent/Continuous Pemigatinib 20 mg QD

param Type

MEAN

population Description

PK/PD Population. Only participants with available data were analyzed.

reporting Status

POSTED

time Frame

Part 1: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14. Part 2: predose on Cycle 1 Days 8 and 14; 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

title

Parts 1 and 2: Cmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)

type

SECONDARY

unit Of Measure

ng/mL

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Preserved source evidence · Not medical advice