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NCT02508532 · OUTCOME

Median PFS on Last Prior Anti-cancer Therapy

(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
Historical data collected at enrollment, all available data on prior therapy was collected

What was measured

Progression Free Survival (PFS) is defined as the time in months from the start of treatment to the date of first documented disease progression or death due to any cause, which ever occurs first. PFS on last prior anti-cancer therapy is defined as the time in months from the start of last prior anti-cancer therapy to progression on that therapy.

Analysis population: Patients enrolled on any dose (Part 1 and Part 2) with data on progression-free survival for the most recent prior therapy

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 Mutation45
2L Patients Without a PDGFRA D842V Mutation51
3L Patients Without a PDGFRA D842V Mutation142

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Patients With a PDGFRA D842V Mutation5.9Not reported4.28.3Not reported
2L Patients Without a PDGFRA D842V Mutation31.0Not reported26.448.0Not reported
3L Patients Without a PDGFRA D842V Mutation6.4Not reported4.38.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.2
        upper Limit
        8.3
        value
        5.9
      2. group Id
        OG001
        lower Limit
        26.4
        upper Limit
        48.0
        value
        31.0
      3. group Id
        OG002
        lower Limit
        4.3
        upper Limit
        8.3
        value
        6.4
denoms
  1. counts
    1. group Id
      OG000
      value
      45
    2. group Id
      OG001
      value
      51
    3. group Id
      OG002
      value
      142
    units
    Participants
description
Progression Free Survival (PFS) is defined as the time in months from the start of treatment to the date of first documented disease progression or death due to any cause, which ever occurs first. PFS on last prior anti-cancer therapy is defined as the time in months from the start of last prior anti-cancer therapy to progression on that therapy.
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 on any dose (Part 1 and Part 2) with data on progression-free survival for the most recent prior therapy
reporting Status
POSTED
time Frame
Historical data collected at enrollment, all available data on prior therapy was collected
title
Median PFS on Last Prior Anti-cancer Therapy
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice