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NCT02508532 · OUTCOME

Part 2: Objective Response Rate (ORR) 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
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

To evaluate objective response rate (ORR) determined by central radiology assessment per mRECIST, version 1.1 in patients with advanced GIST treated with avapritinib. 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 enrolled in Part 1 or Part 2 with a starting dose of 300 or 400 mg, including 13 patients enrolled in Part 1

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

Responder

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients With a PDGFRA D842V Mutation36Not reportedNot reportedNot reportedNot reported
2L Patients Without a PDGFRA D842V Mutation10Not reportedNot reportedNot reportedNot reported
3L Patients Without a PDGFRA D842V Mutation20Not reportedNot reportedNot reportedNot reported

Non-Responder

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients With a PDGFRA D842V Mutation2Not reportedNot reportedNot reportedNot reported
2L Patients Without a PDGFRA D842V Mutation40Not reportedNot reportedNot reportedNot reported
3L Patients Without a PDGFRA D842V Mutation108Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        20
      title
      Responder
    2. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        40
      3. group Id
        OG002
        value
        108
      title
      Non-Responder
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    2. group Id
      OG001
      value
      50
    3. group Id
      OG002
      value
      128
    units
    Participants
description
To evaluate objective response rate (ORR) determined by central radiology assessment per mRECIST, version 1.1 in patients with advanced GIST treated with avapritinib. 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
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
COUNT_OF_PARTICIPANTS
population Description
patients enrolled in Part 1 or Part 2 with a starting dose of 300 or 400 mg, including 13 patients enrolled in Part 1
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
Part 2: Objective Response Rate (ORR) Determined by Central Radiology Assessment Per mRECIST, Version 1.1
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice