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NCT02508532 · OUTCOME

Duration of Response Determined by Central Radiology Assessment 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

Duration from time to first documented CR/PR to date of first documented disease progression or death. A complete response per modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) is defined as complete disappearance of all target lesions. A partial response is defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. Overall Response (OR) = CR + PR

Analysis population: Patients in Part 1 and Part 2 with a starting dose of 300 or 400 mg QD. Only patients that achieved a CR or PR are included in this analysis

Groups in this outcome

Patients With 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 PDGFRA D842V Mutation36
2L Patients Without a PDGFRA D842V Mutation10
3L Patients Without a PDGFRA D842V Mutation20

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Patients With PDGFRA D842V Mutation22.1Not reported14.3NAThe upper bounds of the confidence interval could not be calculated
2L Patients Without a PDGFRA D842V Mutation19.2Not reported9.219.2Not reported
3L Patients Without a PDGFRA D842V Mutation10.2Not reported7.215.0Not 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
        14.3
        upper Limit
        NA
        value
        22.1
      2. group Id
        OG001
        lower Limit
        9.2
        upper Limit
        19.2
        value
        19.2
      3. group Id
        OG002
        lower Limit
        7.2
        upper Limit
        15.0
        value
        10.2
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      20
    units
    Participants
description
Duration from time to first documented CR/PR to date of first documented disease progression or death. A complete response per modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) is defined as complete disappearance of all target lesions. A partial response is defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters. Overall Response (OR) = CR + PR
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with a PDGFRA D842V mutation, any line of treatment
    id
    OG000
    title
    Patients With 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 in Part 1 and Part 2 with a starting dose of 300 or 400 mg QD. Only patients that achieved a CR or PR are included in this analysis
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
Duration of Response Determined by Central Radiology Assessment 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