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NCT02393248 · OUTCOME

Parts 1 and 2: AUC0-24 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
hr*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

AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.

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

GroupSource count
Part 1: Intermittent Pemigatinib 1 mg QD1
Part 1: Intermittent Pemigatinib 2 mg QD1
Part 1: Intermittent Pemigatinib 4 mg QD1
Part 1: Intermittent Pemigatinib 6 mg QD4
Parts 1 and 2: Intermittent/Continuous Pemigatinib 9 mg QD18
Parts 1 and 2: Intermittent/Continuous Pemigatinib 13.5 mg QD57
Parts 1 and 2: Intermittent/Continuous Pemigatinib 20 mg QD13

Reported measurements

Source class 1
Values in hr*ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Intermittent Pemigatinib 1 mg QD208NANot reportedNot reportedA standard deviation was not calculated for a single participant.
Part 1: Intermittent Pemigatinib 2 mg QD322NANot reportedNot reportedA standard deviation was not calculated for a single participant.
Part 1: Intermittent Pemigatinib 4 mg QD1380NANot reportedNot reportedA standard deviation was not calculated for a single participant.
Part 1: Intermittent Pemigatinib 6 mg QD1080301Not reportedNot reportedNot reported
Parts 1 and 2: Intermittent/Continuous Pemigatinib 9 mg QD21801630Not reportedNot reportedNot reported
Parts 1 and 2: Intermittent/Continuous Pemigatinib 13.5 mg QD30101890Not reportedNot reportedNot reported
Parts 1 and 2: Intermittent/Continuous Pemigatinib 20 mg QD43501480Not reportedNot reportedNot reported

Source statistical analyses

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

  1. group Ids
    1. OG003
    2. OG004
    non Inferiority Type
    SUPERIORITY
    p Value
    0.8577
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
    statistical Method
    ANOVA
  2. group Ids
    1. OG003
    2. OG005
    non Inferiority Type
    SUPERIORITY
    p Value
    0.7238
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
    statistical Method
    ANOVA
  3. group Ids
    1. OG003
    2. OG006
    non Inferiority Type
    SUPERIORITY
    p Value
    0.5923
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
    statistical Method
    ANOVA
  4. group Ids
    1. OG004
    2. OG005
    non Inferiority Type
    SUPERIORITY
    p Value
    0.7634
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
    statistical Method
    ANOVA
  5. group Ids
    1. OG004
    2. OG006
    non Inferiority Type
    SUPERIORITY
    p Value
    0.5749
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
    statistical Method
    ANOVA
  6. group Ids
    1. OG005
    2. OG006
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6877
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
    statistical Method
    ANOVA
Complete source fields
analyses
  1. group Ids
    1. OG003
    2. OG004
    non Inferiority Type
    SUPERIORITY
    p Value
    0.8577
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
    statistical Method
    ANOVA
  2. group Ids
    1. OG003
    2. OG005
    non Inferiority Type
    SUPERIORITY
    p Value
    0.7238
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
    statistical Method
    ANOVA
  3. group Ids
    1. OG003
    2. OG006
    non Inferiority Type
    SUPERIORITY
    p Value
    0.5923
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
    statistical Method
    ANOVA
  4. group Ids
    1. OG004
    2. OG005
    non Inferiority Type
    SUPERIORITY
    p Value
    0.7634
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
    statistical Method
    ANOVA
  5. group Ids
    1. OG004
    2. OG006
    non Inferiority Type
    SUPERIORITY
    p Value
    0.5749
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
    statistical Method
    ANOVA
  6. group Ids
    1. OG005
    2. OG006
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6877
    statistical Comment
    1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)
    statistical Method
    ANOVA
classes
  1. categories
    1. measurements
      1. comment
        A standard deviation was not calculated for a single participant.
        group Id
        OG000
        spread
        NA
        value
        208
      2. comment
        A standard deviation was not calculated for a single participant.
        group Id
        OG001
        spread
        NA
        value
        322
      3. comment
        A standard deviation was not calculated for a single participant.
        group Id
        OG002
        spread
        NA
        value
        1380
      4. group Id
        OG003
        spread
        301
        value
        1080
      5. group Id
        OG004
        spread
        1630
        value
        2180
      6. group Id
        OG005
        spread
        1890
        value
        3010
      7. group Id
        OG006
        spread
        1480
        value
        4350
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      18
    6. group Id
      OG005
      value
      57
    7. group Id
      OG006
      value
      13
    units
    Participants
description
AUC0-24 was defined as the area under the plasma or serum concentration-time curve from time 0 to 24 hours post-dose.
dispersion Type
Standard Deviation
groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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: AUC0-24 After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Days 8 and 14 (Steady State)
type
SECONDARY
unit Of Measure
hr*ng/mL

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Preserved source evidence · Not medical advice