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NCT02508532 · OUTCOME

Clinical Benefit Rate 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

Percent of patients with a complete response, partial response or stable disease lasting more than 16 weeks. 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. Stable disease is defined as a tumor that does not meet the criteria for progression or for response. 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 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

Clinical Benefit

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients With a PDGFRA D842V Mutation37Not reportedNot reportedNot reportedNot reported
2L Patients Without a PDGFRA D842V Mutation26Not reportedNot reportedNot reportedNot reported
3L Patients Without a PDGFRA D842V Mutation51Not reportedNot reportedNot reportedNot reported

No Clinical Benefit

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients With a PDGFRA D842V Mutation1Not reportedNot reportedNot reportedNot reported
2L Patients Without a PDGFRA D842V Mutation24Not reportedNot reportedNot reportedNot reported
3L Patients Without a PDGFRA D842V Mutation77Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        26
      3. group Id
        OG002
        value
        51
      title
      Clinical Benefit
    2. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        24
      3. group Id
        OG002
        value
        77
      title
      No Clinical Benefit
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    2. group Id
      OG001
      value
      50
    3. group Id
      OG002
      value
      128
    units
    Participants
description
Percent of patients with a complete response, partial response or stable disease lasting more than 16 weeks. 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. Stable disease is defined as a tumor that does not meet the criteria for progression or for response. 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.
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 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
Clinical Benefit Rate Determined by Central Radiology Assessment Per mRECIST, Version 1.1
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice