NCT02508532 · OUTCOME

Change From Baseline in Levels of KIT and PDGFRα Mutant Allele Fractions in Peripheral Blood

(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: fraction of total
Interval / dispersion: Standard Deviation
Time frame: Baseline and End of treatment

What was measured

Change of mutant allele fraction (MAF) summarizes the largest fold change. Change from baseline only displayed for patients with pre and post treatment MAF measurements. A positive number represents an increase in MAF. Data is only provided for patients that had both a baseline measurement and an end of treatment measurement.

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

Groups in this outcome

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

Part 1 and Part 2: Patients enrolled in Part 1 and Part 2 at a starting dose of 300 or 400 mg QD were included in the Part1/Part 2 safety and efficacy analysis. 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
Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 mg or 400 mg QD	1

Reported measurements

Change in PDGFRA MAF

Values in fraction of total · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 mg or 400 mg QD	8.702	NA	Not reported	Not reported	Only one patient had data for this outcome measure so the standard deviation cannot be calculated

Change in KIT MAF

Values in fraction of total · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 mg or 400 mg QD	14.398	NA	Not reported	Not reported	Only one patient had data for this outcome measure so the standard deviation cannot be calculated

Complete source fields

classes

categories
measurements
comment
Only one patient had data for this outcome measure so the standard deviation cannot be calculated
group Id
OG000
spread
NA
value
8.702
title
Change in PDGFRA MAF
categories
measurements
comment
Only one patient had data for this outcome measure so the standard deviation cannot be calculated
group Id
OG000
spread
NA
value
14.398
title
Change in KIT MAF

denoms

counts
group Id
OG000
value
1
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Part 1 and Part 2: Patients enrolled in Part 1 and Part 2 at a starting dose of 300 or 400 mg QD were included in the Part1/Part 2 safety and efficacy analysis. Patients received avapritinib in continuous 28 day cycles until discontinuation.
id
OG000
title
Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 mg or 400 mg QD

param Type

MEAN

population Description

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

reporting Status

POSTED

time Frame

Baseline and End of treatment

title

Change From Baseline in Levels of KIT and PDGFRα Mutant Allele Fractions in Peripheral Blood

type

SECONDARY

unit Of Measure

fraction of total

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

Preserved source evidence · Not medical advice