NCT02508532 · OUTCOME

Apparent Volume of Distribution, Unadjusted for Bioavailability (Vz/F)

(NAVIGATOR) Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors · Source last updated 2022-06-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: L
Interval / dispersion: Standard Error
Time frame: Cycle 1 Day 1

What was measured

Apparent volume of distribution, unadjusted for bioavailability (Vz/F) following a single dose of avapritinib

Analysis population: Patients enrolled in Part 1 and Part 2 with a starting dose of 300 or 400 mg QD and available PK samples

Groups in this outcome

Part 1 and Part 2: Avapritinib (Formerly BLU-285) 300 mg QD

Part 1 and Part 2: Patients received a starting dose of 300 mg QD. Patients received avapritinib in continuous 28 day cycles until discontinuation.

Part 1 and Part 2: Avapritinib (Formerly BLU-285) 400 mg QD

Part 1 and Part 2: Patients received a starting dose of 400 mg QD. Patients received avapritinib in continuous 28 day cycles until discontinuation.

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
Part 1 and Part 2: Avapritinib (Formerly BLU-285) 300 mg QD	23
Part 1 and Part 2: Avapritinib (Formerly BLU-285) 400 mg QD	8

Reported measurements

Source class 1

Values in L · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Part 1 and Part 2: Avapritinib (Formerly BLU-285) 300 mg QD	1310	676	Not reported	Not reported	Not reported
Part 1 and Part 2: Avapritinib (Formerly BLU-285) 400 mg QD	1340	597	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
676
value
1310
group Id
OG001
spread
597
value
1340

denoms

counts
group Id
OG000
value
23
group Id
OG001
value
8
units
Participants

description

Apparent volume of distribution, unadjusted for bioavailability (Vz/F) following a single dose of avapritinib

dispersion Type

Standard Error

groups

description
Part 1 and Part 2: Patients received a starting dose of 300 mg QD. Patients received avapritinib in continuous 28 day cycles until discontinuation.
id
OG000
title
Part 1 and Part 2: Avapritinib (Formerly BLU-285) 300 mg QD
description
Part 1 and Part 2: Patients received a starting dose of 400 mg QD. Patients received avapritinib in continuous 28 day cycles until discontinuation.
id
OG001
title
Part 1 and Part 2: Avapritinib (Formerly BLU-285) 400 mg QD

param Type

MEAN

population Description

Patients enrolled in Part 1 and Part 2 with a starting dose of 300 or 400 mg QD and available PK samples

reporting Status

POSTED

time Frame

Cycle 1 Day 1

title

Apparent Volume of Distribution, Unadjusted for Bioavailability (Vz/F)

type

SECONDARY

unit Of Measure

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice