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NCT02034110 · OUTCOME

Duration of Response (DoR) in the Adenocarcinoma of the Small Intestine (ASI) 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
MEDIAN
Unit
Weeks
Interval / dispersion
95% Confidence Interval
Time frame
From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)

What was measured

For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.

Analysis population: ITT/Evaluable population - Primary analysis cohort. Only responders were included in the analysis.

Groups in this outcome

Adenocarcinoma of the Small Intestine (ASI)

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
Adenocarcinoma of the Small Intestine (ASI)2

Reported measurements

Investigator assessment
Values in Weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Adenocarcinoma of the Small Intestine (ASI)33.4Not reportedNANANot estimable due to insufficient events observed.
Independent radiology review
Values in Weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Adenocarcinoma of the Small Intestine (ASI)32.8Not reported32.1NANot estimable due to insufficient events observed.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not estimable due to insufficient events observed.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        33.4
    title
    Investigator assessment
  2. categories
    1. measurements
      1. comment
        Not estimable due to insufficient events observed.
        group Id
        OG000
        lower Limit
        32.1
        upper Limit
        NA
        value
        32.8
    title
    Independent radiology review
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
For the subset of subjects who showed a confirmed response as defined for each cohort, Duration of Response (DoR) was defined as the time (in weeks) from first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever was first. If the subject did not have a documented date of progression or death, DoR was censored at the date of the last adequate assessment.
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
    Adenocarcinoma of the Small Intestine (ASI)
param Type
MEDIAN
population Description
ITT/Evaluable population - Primary analysis cohort. Only responders were included in the analysis.
reporting Status
POSTED
time Frame
From first documented evidence of response (the first response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
title
Duration of Response (DoR) in the Adenocarcinoma of the Small Intestine (ASI) Cohort
type
SECONDARY
unit Of Measure
Weeks

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

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