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NCT02508532 · OUTCOME

Time of Maximal Concentration (Tmax) at Steady State

(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
h
Interval / dispersion
Full Range
Time frame
Cycle 1 Day 15

What was measured

Time of maximal concentration (Tmax) at steady state following 15 days of QD dosing

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 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 QD110
Part 1 and Part 2: Avapritinib (Formerly BLU-285) 400 mg QD38

Reported measurements

Source class 1
Values in h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Avapritinib (Formerly BLU-285) 300 mg QD4.0Not reported0.08.17Not reported
Part 1 and Part 2: Avapritinib (Formerly BLU-285) 400 mg QD3.99Not reported0.58.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        8.17
        value
        4.0
      2. group Id
        OG001
        lower Limit
        0.5
        upper Limit
        8.0
        value
        3.99
denoms
  1. counts
    1. group Id
      OG000
      value
      110
    2. group Id
      OG001
      value
      38
    units
    Participants
description
Time of maximal concentration (Tmax) at steady state following 15 days of QD dosing
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 a starting dose of 300 or 400 mg QD and available samples for PK
reporting Status
POSTED
time Frame
Cycle 1 Day 15
title
Time of Maximal Concentration (Tmax) at Steady State
type
SECONDARY
unit Of Measure
h

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

Preserved source evidence · Not medical advice