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NCT02393248 · OUTCOME

Part 3: Tmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 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
MEDIAN
Unit
hr
Interval / dispersion
Full Range
Time frame
predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14

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 3: Pem/Intermittent Pemigatinib 9 mg

Participants received pembrolizumab (Pem) intravenously at 200 mg once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 9 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. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.

Part 3: Pem/Intermittent Pemigatinib 13.5 mg

Participants received pembrolizumab intravenously at 200 mg once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. 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. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.

Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg

Participants received gemcitabine intravenously starting at 1000 mg/m\^2 on Days 1 and 8 of each 21-day cycle. Cisplatin was administered intravenously starting at 70 mg/m\^2 once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. 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. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin.

Part 3: Doc/Intermittent Pemigatinib 13.5 mg

Participants received docetaxel (Doc) intravenously starting at 75 mg/m\^2 once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. 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. It was permissible to continue pemigatinib administration during the toxicity break of docetaxel.

Part 3: Tras/Intermittent Pemigatinib 13.5 mg

Trastuzumab (Tras) was administered as an open-label, commercial product at an initial intravenous dose of 8 mg/kilograms (kg), followed by 6 mg/kg intravenously once every 3 weeks. The dose could have been adjusted for toxicity management, per commercial labeling. The investigator could have interrupted, modified, or discontinued trastuzumab with medical monitor approval. 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. It was permissible to continue pemigatinib administration during the toxicity break of trastuzumab.

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 3: Pem/Intermittent Pemigatinib 9 mg3
Part 3: Pem/Intermittent Pemigatinib 13.5 mg14
Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg4
Part 3: Doc/Intermittent Pemigatinib 13.5 mg5
Part 3: Tras/Intermittent Pemigatinib 13.5 mg5

Reported measurements

Source class 1
Values in hr · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 3: Pem/Intermittent Pemigatinib 9 mg5.78Not reported1.256.08Not reported
Part 3: Pem/Intermittent Pemigatinib 13.5 mg1.08Not reported0.5007.98Not reported
Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg1.50Not reported0.9504.00Not reported
Part 3: Doc/Intermittent Pemigatinib 13.5 mg1.90Not reported0.5002.08Not reported
Part 3: Tras/Intermittent Pemigatinib 13.5 mg0.583Not reported0.5001.07Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.25
        upper Limit
        6.08
        value
        5.78
      2. group Id
        OG001
        lower Limit
        0.500
        upper Limit
        7.98
        value
        1.08
      3. group Id
        OG002
        lower Limit
        0.950
        upper Limit
        4.00
        value
        1.50
      4. group Id
        OG003
        lower Limit
        0.500
        upper Limit
        2.08
        value
        1.90
      5. group Id
        OG004
        lower Limit
        0.500
        upper Limit
        1.07
        value
        0.583
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      14
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      5
    5. group Id
      OG004
      value
      5
    units
    Participants
description
tmax was defined as the time to the maximum observed plasma concentration.
dispersion Type
Full Range
groups
  1. description
    Participants received pembrolizumab (Pem) intravenously at 200 mg once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 9 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. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.
    id
    OG000
    title
    Part 3: Pem/Intermittent Pemigatinib 9 mg
  2. description
    Participants received pembrolizumab intravenously at 200 mg once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. 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. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.
    id
    OG001
    title
    Part 3: Pem/Intermittent Pemigatinib 13.5 mg
  3. description
    Participants received gemcitabine intravenously starting at 1000 mg/m\^2 on Days 1 and 8 of each 21-day cycle. Cisplatin was administered intravenously starting at 70 mg/m\^2 once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. 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. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin.
    id
    OG002
    title
    Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg
  4. description
    Participants received docetaxel (Doc) intravenously starting at 75 mg/m\^2 once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. 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. It was permissible to continue pemigatinib administration during the toxicity break of docetaxel.
    id
    OG003
    title
    Part 3: Doc/Intermittent Pemigatinib 13.5 mg
  5. description
    Trastuzumab (Tras) was administered as an open-label, commercial product at an initial intravenous dose of 8 mg/kilograms (kg), followed by 6 mg/kg intravenously once every 3 weeks. The dose could have been adjusted for toxicity management, per commercial labeling. The investigator could have interrupted, modified, or discontinued trastuzumab with medical monitor approval. 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. It was permissible to continue pemigatinib administration during the toxicity break of trastuzumab.
    id
    OG004
    title
    Part 3: Tras/Intermittent Pemigatinib 13.5 mg
param Type
MEDIAN
population Description
PK/PD Population. Only participants with available data were analyzed.
reporting Status
POSTED
time Frame
predose and 0.5, 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 14
title
Part 3: Tmax of Pemigatinib as Part of Combination Therapy on Cycle 1 Day 14 (Steady State)
type
SECONDARY
unit Of Measure
hr

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