Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02508532 · OUTCOME

Time to Maximum Plasma Drug Concentration (Tmax)

(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
hours
Interval / dispersion
Full Range
Time frame
Cycle 1 Day 1

What was measured

Cycle 1 Day 1 PK time to maximum plasma drug concentration (Tmax)

Analysis population: Patients enrolled in Part 1 and Part 2 with available samples for PK

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

GroupSource count
Part 1 and Part 2: Avapritinib (Formerly BLU-285) 300 mg QD113
Part 1 and Part 2: Avapritinib (Formerly BLU-285) 400 mg QD50

Reported measurements

Source class 1
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Avapritinib (Formerly BLU-285) 300 mg QD4.0Not reported0.9823.5Not reported
Part 1 and Part 2: Avapritinib (Formerly BLU-285) 400 mg QD4.02Not reported1.9724.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.98
        upper Limit
        23.5
        value
        4.0
      2. group Id
        OG001
        lower Limit
        1.97
        upper Limit
        24.0
        value
        4.02
denoms
  1. counts
    1. group Id
      OG000
      value
      113
    2. group Id
      OG001
      value
      50
    units
    Participants
description
Cycle 1 Day 1 PK time to maximum plasma drug concentration (Tmax)
dispersion Type
Full Range
groups
  1. 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
  2. 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
MEDIAN
population Description
Patients enrolled in Part 1 and Part 2 with available samples for PK
reporting Status
POSTED
time Frame
Cycle 1 Day 1
title
Time to Maximum Plasma Drug Concentration (Tmax)
type
SECONDARY
unit Of Measure
hours

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

Preserved source evidence · Not medical advice