NCT02508532 · OUTCOME

Maximum Plasma Drug Concentration (Cmax)

(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: MEDIAN
Unit: ng/mL
Interval / dispersion: Standard Deviation
Time frame: Cycle 1 Day 1

What was measured

Maximum plasma drug concentration (Cmax) 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 samples for PK

Groups in this outcome

Part 1 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 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 Avapritinib (Formerly BLU-285) 300 mg QD	113
Part 1 Avapritinib (Formerly BLU-285) 400 mg QD	50

Reported measurements

Source class 1

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 1 Avapritinib (Formerly BLU-285) 300 mg QD	305	153	Not reported	Not reported	Not reported
Part 1 Avapritinib (Formerly BLU-285) 400 mg QD	343	181	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
153
value
305
group Id
OG001
spread
181
value
343

denoms

counts
group Id
OG000
value
113
group Id
OG001
value
50
units
Participants

description

Maximum plasma drug concentration (Cmax) following a single dose of avapritinib

dispersion Type

Standard Deviation

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 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 Avapritinib (Formerly BLU-285) 400 mg QD

param Type

MEDIAN

population Description

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

reporting Status

POSTED

time Frame

Cycle 1 Day 1

title

Maximum Plasma Drug Concentration (Cmax)

type

SECONDARY

unit Of Measure

ng/mL

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

Preserved source evidence · Not medical advice