Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02508532 · OUTCOME

Part 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Avapritinib

(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
NUMBER
Unit
patients with event(s) of dose-limiting
Interval / dispersion
Not reported
Time frame
Cycle 1 (28 days) of treatment

What was measured

Patients with event(s) of dose-limiting toxicity

Analysis population: Patients that completed Part 1 or had a DLT

Groups in this outcome

Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD

Part 1: Patients received a starting dose of 30 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.

Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD

Part 1: Patients received a starting dose of 60 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.

Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD

Part 1: Patients received a starting dose of 90 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.

Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD

Part 1: Patients received a starting dose of 135 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.

Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD

Part 1: Patients received a starting dose of 200 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation. .

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

Part 1: Patients received a starting dose of 300 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation. Patients that received at least one dose of avapritinib were included in the Part 2 analysis.

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

Part 1: Patients received a starting dose of 400 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation. Patients that received at least one dose of avapritinib were included in the Part 2 analysis.

Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD

Part 1: Patients received a starting dose of 600 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. 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
Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD6
Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD6
Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD6
Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD6
Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD6
Experimental: Part 1 Avapritinib (Formerly BLU-285) 300 mg QD6
Experimental: Part 1 Avapritinib (Formerly BLU-285) 400 mg QD6
Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD2

Reported measurements

Source class 1
Values in patients with event(s) of dose-limiting · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD0Not reportedNot reportedNot reportedNot reported
Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD0Not reportedNot reportedNot reportedNot reported
Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD0Not reportedNot reportedNot reportedNot reported
Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD0Not reportedNot reportedNot reportedNot reported
Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD0Not reportedNot reportedNot reportedNot reported
Experimental: Part 1 Avapritinib (Formerly BLU-285) 300 mg QD0Not reportedNot reportedNot reportedNot reported
Experimental: Part 1 Avapritinib (Formerly BLU-285) 400 mg QD0Not reportedNot reportedNot reportedNot reported
Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      6
    8. group Id
      OG007
      value
      2
    units
    Participants
description
Patients with event(s) of dose-limiting toxicity
groups
  1. description
    Part 1: Patients received a starting dose of 30 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
    id
    OG000
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD
  2. description
    Part 1: Patients received a starting dose of 60 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
    id
    OG001
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD
  3. description
    Part 1: Patients received a starting dose of 90 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
    id
    OG002
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD
  4. description
    Part 1: Patients received a starting dose of 135 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
    id
    OG003
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD
  5. description
    Part 1: Patients received a starting dose of 200 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation. .
    id
    OG004
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD
  6. description
    Part 1: Patients received a starting dose of 300 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation. Patients that received at least one dose of avapritinib were included in the Part 2 analysis.
    id
    OG005
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 300 mg QD
  7. description
    Part 1: Patients received a starting dose of 400 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation. Patients that received at least one dose of avapritinib were included in the Part 2 analysis.
    id
    OG006
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 400 mg QD
  8. description
    Part 1: Patients received a starting dose of 600 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
    id
    OG007
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD
param Type
NUMBER
population Description
Patients that completed Part 1 or had a DLT
reporting Status
POSTED
time Frame
Cycle 1 (28 days) of treatment
title
Part 1: Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Avapritinib
type
PRIMARY
unit Of Measure
patients with event(s) of dose-limiting

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

Preserved source evidence · Not medical advice