NCT02393248 · OUTCOME

Highest Serum Phosphate Concentration Following Pemigatinib as Monotherapy in Parts 1 and 2

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: NUMBER
Unit: mg/dL
Interval / dispersion: Not reported
Time frame: predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles

What was measured

Serum phosphate concentration was assessed throughout Parts 1 and 2.

Analysis population: PK/PD Population. The average serum concentration of phosphate on Cycle 1 Days 8 and 15 was chosen as a dependent variable for E-R analysis, which was independent of the intermittent dosing and continuous dosing regimens. Therefore, the intermittent dosing and continuous dosing groups from Parts 1 and 2 were combined into a single analysis group for E-R analysis.

Groups in this outcome

Parts 1 and 2: Intermittent or Continuous Pemigatinib

Participant self-administered intermittent pemigatinib once daily (QD) or continuous pemigatinib QD or twice daily (BID). Intermittent dosing: participants self-administered oral pemigatinib 1/2/4 milligrams (mg), 6 mg, 9 mg, 13.5 mg, or 20 mg once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule in 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, 13.5 mg, or 20 mg QD on Days 1 through 21 of each 21-day cycle in Part 1 or Part 2. Participants self-administered oral pemigatinib 7.5 mg or 10 mg BID on Days 1 through 21 of each 21-day cycle in Part 1.

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
Parts 1 and 2: Intermittent or Continuous Pemigatinib	93

Reported measurements

Minimum value in range of highest values for all participants

Values in mg/dL · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Parts 1 and 2: Intermittent or Continuous Pemigatinib	3.5	Not reported	Not reported	Not reported	Not reported

Maximum value in range of highest values for all participants

Values in mg/dL · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Parts 1 and 2: Intermittent or Continuous Pemigatinib	11.2	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
3.5
title
Minimum value in range of highest values for all participants
categories
measurements
group Id
OG000
value
11.2
title
Maximum value in range of highest values for all participants

denoms

counts
group Id
OG000
value
93
units
Participants

description

Serum phosphate concentration was assessed throughout Parts 1 and 2.

groups

description
Participant self-administered intermittent pemigatinib once daily (QD) or continuous pemigatinib QD or twice daily (BID). Intermittent dosing: participants self-administered oral pemigatinib 1/2/4 milligrams (mg), 6 mg, 9 mg, 13.5 mg, or 20 mg once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule in 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, 13.5 mg, or 20 mg QD on Days 1 through 21 of each 21-day cycle in Part 1 or Part 2. Participants self-administered oral pemigatinib 7.5 mg or 10 mg BID on Days 1 through 21 of each 21-day cycle in Part 1.
id
OG000
title
Parts 1 and 2: Intermittent or Continuous Pemigatinib

param Type

NUMBER

population Description

PK/PD Population. The average serum concentration of phosphate on Cycle 1 Days 8 and 15 was chosen as a dependent variable for E-R analysis, which was independent of the intermittent dosing and continuous dosing regimens. Therefore, the intermittent dosing and continuous dosing groups from Parts 1 and 2 were combined into a single analysis group for E-R analysis.

reporting Status

POSTED

time Frame

predose on Days 1 and 14 of Cycle 1; anytime during visit on Day 1 of Cycle 2 and all subsequent cycles

title

Highest Serum Phosphate Concentration Following Pemigatinib as Monotherapy in Parts 1 and 2

type

PRIMARY

unit Of Measure

mg/dL

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Preserved source evidence · Not medical advice