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NCT02034110 · OUTCOME

Overall Response Rate (ORR) in the Gastrointestinal Stromal Tumor (GIST) Cohort

Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers · Source last updated 2023-08-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)

What was measured

Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response \[CR\], partial response \[PR\]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Analysis population: ITT/Evaluable population - Primary and expansion cohort combined

Groups in this outcome

Gastrointestinal Stromal Tumor (GIST)

All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.

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

Analysis denominator · Participants

GroupSource count
Gastrointestinal Stromal Tumor (GIST)1

Reported measurements

Investigator assessment @ 78 months
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Gastrointestinal Stromal Tumor (GIST)0Not reportedNANA95% Confidence Interval not determined as there are an insufficient number of participants with events.
Investigator assessment @ 92 months
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Gastrointestinal Stromal Tumor (GIST)0Not reportedNANA95% Confidence Interval not determined as there are an insufficient number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        95% Confidence Interval not determined as there are an insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        0
    title
    Investigator assessment @ 78 months
  2. categories
    1. measurements
      1. comment
        95% Confidence Interval not determined as there are an insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        0
    title
    Investigator assessment @ 92 months
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
description
Overall Response Rate (ORR) was defined as the percentage of participants with a tumor response (complete response \[CR\], partial response \[PR\]) by investigator assessment as defined by RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
dispersion Type
95% Confidence Interval
groups
  1. description
    All subjects enrolled received oral dabrafenib 150 mg bid in combination with oral trametinib 2 mg once daily. Subjects continued treatment until an unacceptable toxicity, disease progression, or death.
    id
    OG000
    title
    Gastrointestinal Stromal Tumor (GIST)
param Type
NUMBER
population Description
ITT/Evaluable population - Primary and expansion cohort combined
reporting Status
POSTED
time Frame
From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21)
title
Overall Response Rate (ORR) in the Gastrointestinal Stromal Tumor (GIST) Cohort
type
PRIMARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Independent clinical review pending · Not medical advice