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NCT02034110 · OUTCOME

Progression Free Survival (PFS) 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 study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)

What was measured

Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.

Analysis population: ITT/Evaluable population - Primary analysis cohort.

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)3

Reported measurements

Investigator assessment
Values in Weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Adenocarcinoma of the Small Intestine (ASI)41.3Not 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)40.1Not reported4.1NANot 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
        41.3
    title
    Investigator assessment
  2. categories
    1. measurements
      1. comment
        Not estimable due to insufficient events observed
        group Id
        OG000
        lower Limit
        4.1
        upper Limit
        NA
        value
        40.1
    title
    Independent radiology review
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    units
    Participants
description
Progression Free Survival (PFS) was defined as the interval between the first dose of study treatment and earlier date of first radiologically documented progression or death due to any cause. If the subject did not have a documented date of progression or death, PFS was censored at the date of the last adequate assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
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.
reporting Status
POSTED
time Frame
From study treatment start date until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 92 months (cut-off date for end of study = 10-Dec-21)
title
Progression Free Survival (PFS) 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