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NCT02393248 · OUTCOME

Parts 1 and 2: Tmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1

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
MEDIAN
Unit
hours (hr)
Interval / dispersion
Full Range
Time frame
Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1

What was measured

tmax was defined as the time to 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

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 QD21
Parts 1 and 2: Intermittent/Continuous Pemigatinib 13.5 mg QD69
Parts 1 and 2: Intermittent/Continuous Pemigatinib 20 mg QD69

Reported measurements

Source class 1
Values in hours (hr) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: Intermittent Pemigatinib 1 mg QD1Not reportedNANAA range was not available for a single participant.
Part 1: Intermittent Pemigatinib 2 mg QD5.92Not reportedNANAA range was not available for a single participant.
Part 1: Intermittent Pemigatinib 4 mg QD2.02Not reportedNANAA range was not available for a single participant.
Part 1: Intermittent Pemigatinib 6 mg QD1.14Not reported1.002.08Not reported
Parts 1 and 2: Intermittent/Continuous Pemigatinib 9 mg QD1.17Not reported0.5002.13Not reported
Parts 1 and 2: Intermittent/Continuous Pemigatinib 13.5 mg QD1.20Not reported0.40026.1Not reported
Parts 1 and 2: Intermittent/Continuous Pemigatinib 20 mg QD1.98Not reported0.50022.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        A range was not available for a single participant.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        1
      2. comment
        A range was not available for a single participant.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        5.92
      3. comment
        A range was not available for a single participant.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        2.02
      4. group Id
        OG003
        lower Limit
        1.00
        upper Limit
        2.08
        value
        1.14
      5. group Id
        OG004
        lower Limit
        0.500
        upper Limit
        2.13
        value
        1.17
      6. group Id
        OG005
        lower Limit
        0.400
        upper Limit
        26.1
        value
        1.20
      7. group Id
        OG006
        lower Limit
        0.500
        upper Limit
        22.9
        value
        1.98
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
      21
    6. group Id
      OG005
      value
      69
    7. group Id
      OG006
      value
      69
    units
    Participants
description
tmax was defined as the time to the maximum observed plasma concentration.
dispersion Type
Full Range
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
MEDIAN
population Description
PK/PD Population. Only participants with available data were analyzed.
reporting Status
POSTED
time Frame
Part 1: predose; 0.5, 1, 2, 4, 6, and 8 hours post-dose post-dose on Cycle 1 Day 1. Part 2: predose on Cycle 1 Day 1
title
Parts 1 and 2: Tmax After Once Daily Dosing of Pemigatinib as Monotherapy on Cycle 1 Day 1
type
SECONDARY
unit Of Measure
hours (hr)

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Preserved source evidence · Not medical advice