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NCT02034110 · OUTCOME

Overall Response Rate (ORR) in the Biliary Tract Cancer (BTC) 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

Biliary Tract Cancer (BTC)

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
Biliary Tract Cancer (BTC)43

Reported measurements

Investigator assessment @ up to 78 months
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Biliary Tract Cancer (BTC)53Not reported37.768.8Not reported
Investigator assessment @ up to 92 months
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Biliary Tract Cancer (BTC)53Not reported37.768.8Not reported
Independent radiology review @ up to 78 months
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Biliary Tract Cancer (BTC)47Not reported31.262.3Not reported
Independent radiology review @ up to 92 months
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Biliary Tract Cancer (BTC)47Not reported31.262.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        37.7
        upper Limit
        68.8
        value
        53
    title
    Investigator assessment @ up to 78 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        37.7
        upper Limit
        68.8
        value
        53
    title
    Investigator assessment @ up to 92 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        31.2
        upper Limit
        62.3
        value
        47
    title
    Independent radiology review @ up to 78 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        31.2
        upper Limit
        62.3
        value
        47
    title
    Independent radiology review @ up to 92 months
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    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
    Biliary Tract Cancer (BTC)
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 Biliary Tract Cancer (BTC) 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