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NCT02508532 · OUTCOME

Progression-free Survival Per mRECIST Version 1.1

(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
months
Interval / dispersion
95% Confidence Interval
Time frame
Tumor assessments were performed at screening, Cycle 3 Day 1, then every 2 cycles through Cycle 13, then every 3 cycles thereafter up to approximately 4 years. Each cycle is 28 days.

What was measured

Progression-free survival is defined as the time in months from the start of treatment to the date of first documented progression or death due to any cause. Progression-free survival determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST), version 1.1 in patients with advanced GIST. A progressively growing tumor must meet the following criteria: a) the target lesions must be greater or equal to 2cm in size and be a new GIST active lesion or b) the target lesions must be expanding on at least 2 sequential imaging studies.

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

Groups in this outcome

Patients With a PDGFRA D842V Mutation

Patients with a PDGFRA D842V mutation, any line of treatment

2L Patients Without a PDGFRA D842V Mutation

Patients that do not have a PDGFRA D842V mutation and have received 1 prior line of therapy

3L Patients Without a PDGFRA D842V Mutation

Patients that do not have a PDGFRA D842V mutation and have had 2 or more prior lines of therapy

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Patients With a PDGFRA D842V Mutation38
2L Patients Without a PDGFRA D842V Mutation50
3L Patients Without a PDGFRA D842V Mutation128

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Patients With a PDGFRA D842V Mutation27.6Not reported19.5NAThe upper bounds of the confidence interval could not be calculated
2L Patients Without a PDGFRA D842V Mutation5.5Not reported2.09.4Not reported
3L Patients Without a PDGFRA D842V Mutation3.7Not reported3.65.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper bounds of the confidence interval could not be calculated
        group Id
        OG000
        lower Limit
        19.5
        upper Limit
        NA
        value
        27.6
      2. group Id
        OG001
        lower Limit
        2.0
        upper Limit
        9.4
        value
        5.5
      3. group Id
        OG002
        lower Limit
        3.6
        upper Limit
        5.6
        value
        3.7
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    2. group Id
      OG001
      value
      50
    3. group Id
      OG002
      value
      128
    units
    Participants
description
Progression-free survival is defined as the time in months from the start of treatment to the date of first documented progression or death due to any cause. Progression-free survival determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST), version 1.1 in patients with advanced GIST. A progressively growing tumor must meet the following criteria: a) the target lesions must be greater or equal to 2cm in size and be a new GIST active lesion or b) the target lesions must be expanding on at least 2 sequential imaging studies.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with a PDGFRA D842V mutation, any line of treatment
    id
    OG000
    title
    Patients With a PDGFRA D842V Mutation
  2. description
    Patients that do not have a PDGFRA D842V mutation and have received 1 prior line of therapy
    id
    OG001
    title
    2L Patients Without a PDGFRA D842V Mutation
  3. description
    Patients that do not have a PDGFRA D842V mutation and have had 2 or more prior lines of therapy
    id
    OG002
    title
    3L Patients Without a PDGFRA D842V Mutation
param Type
MEDIAN
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
Tumor assessments were performed at screening, Cycle 3 Day 1, then every 2 cycles through Cycle 13, then every 3 cycles thereafter up to approximately 4 years. Each cycle is 28 days.
title
Progression-free Survival Per mRECIST Version 1.1
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice