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NCT02393248 · OUTCOME

Parts 1 and 2: Cmin Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States

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
Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14

What was measured

Cmin was defined as the minimum observed plasma concentration over the dose interval.

Analysis population: PK/PD Population. Only participants who participated in the food-effect study in Part 2 were analyzed.

Groups in this outcome

Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fasted

Participants self-administered intermittent or continuous pemigatinib 13.5 mg QD in the fasted state in 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. 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.

Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fed

Participants self-administered intermittent or continuous pemigatinib 13.5 mg QD in the fed state in 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. 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.

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 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fasted12
Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fed12

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fasted61.133.5Not reportedNot reportedNot reported
Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fed65.734.7Not reportedNot reportedNot reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.128
    statistical Comment
    crossover ANOVA of log-transformed data
    statistical Method
    ANOVA
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.128
    statistical Comment
    crossover ANOVA of log-transformed data
    statistical Method
    ANOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        33.5
        value
        61.1
      2. group Id
        OG001
        spread
        34.7
        value
        65.7
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      12
    units
    Participants
description
Cmin was defined as the minimum observed plasma concentration over the dose interval.
dispersion Type
Standard Deviation
groups
  1. description
    Participants self-administered intermittent or continuous pemigatinib 13.5 mg QD in the fasted state in 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. 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.
    id
    OG000
    title
    Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fasted
  2. description
    Participants self-administered intermittent or continuous pemigatinib 13.5 mg QD in the fed state in 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. 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.
    id
    OG001
    title
    Part 2: Intermittent/Continuous Pemigatinib 13.5 mg QD, Fed
param Type
MEAN
population Description
PK/PD Population. Only participants who participated in the food-effect study in Part 2 were analyzed.
reporting Status
POSTED
time Frame
Cycles 1 and 2: predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Day 14
title
Parts 1 and 2: Cmin Steady State Following Administration of Pemigatinib in the Fasted (Cycle 1 Day 14) and Fed (Cycle 2 Day 14) States
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice