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NCT02508532 · OUTCOME

Parts 1 and 2: Number of Patients With Adverse Events (AE) and Serious Adverse Events (SAE)

(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
participants
Interval / dispersion
Not reported
Time frame
AEs were collected from the start of study drug until 30 days after the last dose, SAEs were collected from the date of the informed consent signature until 30 days after the last dose of study drug, up to 5 years

What was measured

The overall safety profile of the drug was assessed by reviewing the number of patients with AEs, SAEs and other events. There was no formal statistical analysis. Safety assessments continued for the duration of treatment.

Analysis population: Safety Population - all patients that received at least one dose of avapritinib

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) 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.

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. 13 patients in this group were enrolled in Part 1 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) 600 mg QD3
Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 mg or 400 mg QD217

Reported measurements

Participants with an Adverse Event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD6Not reportedNot reportedNot reportedNot reported
Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD6Not reportedNot reportedNot reportedNot reported
Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD6Not reportedNot reportedNot reportedNot reported
Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD6Not reportedNot reportedNot reportedNot reported
Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD6Not reportedNot reportedNot reportedNot reported
Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD3Not reportedNot reportedNot reportedNot reported
Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 mg or 400 mg QD216Not reportedNot reportedNot reportedNot reported
Participants with a Serious Adverse Event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD3Not reportedNot reportedNot reportedNot reported
Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD4Not reportedNot reportedNot reportedNot reported
Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD5Not reportedNot reportedNot reportedNot reported
Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD5Not reportedNot reportedNot reportedNot reported
Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD5Not reportedNot reportedNot reportedNot reported
Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD3Not reportedNot reportedNot reportedNot reported
Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 mg or 400 mg QD140Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      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
        3
      7. group Id
        OG006
        value
        216
    title
    Participants with an Adverse Event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        140
    title
    Participants with a Serious Adverse Event
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
      3
    7. group Id
      OG006
      value
      217
    units
    Participants
description
The overall safety profile of the drug was assessed by reviewing the number of patients with AEs, SAEs and other events. There was no formal statistical analysis. Safety assessments continued for the duration of treatment.
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 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
    OG005
    title
    Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD
  7. 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. 13 patients in this group were enrolled in Part 1 Patients received avapritinib in continuous 28 day cycles until discontinuation.
    id
    OG006
    title
    Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 mg or 400 mg QD
param Type
NUMBER
population Description
Safety Population - all patients that received at least one dose of avapritinib
reporting Status
POSTED
time Frame
AEs were collected from the start of study drug until 30 days after the last dose, SAEs were collected from the date of the informed consent signature until 30 days after the last dose of study drug, up to 5 years
title
Parts 1 and 2: Number of Patients With Adverse Events (AE) and Serious Adverse Events (SAE)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice