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NCT01072175 · OUTCOME

Part C (Randomized): Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response as Assessed by the Investigator

Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212 · Source last updated 2019-07-05

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
From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 7 years)

What was measured

Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters \[mm\] in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]). Participants with unknown or missing responses were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by an investigator as per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

Analysis population: Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered

Groups in this outcome

Part C: Dabrafenib 150 mg

Participants received dabrafenib 150 mg gelatin capsules BID.

Part C: Dabrafenib 150 mg + Trametinib 1 mg

Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.

Part C: Dabrafenib 150 mg + Trametinib 2 mg

Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.

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

Analysis denominator · Participants

GroupSource count
Part C: Dabrafenib 150 mg54
Part C: Dabrafenib 150 mg + Trametinib 1 mg54
Part C: Dabrafenib 150 mg + Trametinib 2 mg54

Reported measurements

CR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg2Not reportedNot reportedNot reportedNot reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg6Not reportedNot reportedNot reportedNot reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg10Not reportedNot reportedNot reportedNot reported
PR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part C: Dabrafenib 150 mg27Not reportedNot reportedNot reportedNot reported
Part C: Dabrafenib 150 mg + Trametinib 1 mg21Not reportedNot reportedNot reportedNot reported
Part C: Dabrafenib 150 mg + Trametinib 2 mg31Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -23.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    15.9
    group Description
    Difference in response rate Arm2 - Arm1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Unconditional exact method
    param Value
    -4
  2. ci Lower Limit
    2.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    40.7
    group Description
    Difference in response rate Arm3 - Arm1
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Unconditional exact method
    param Value
    22
Complete source fields
analyses
  1. ci Lower Limit
    -23.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    15.9
    group Description
    Difference in response rate Arm2 - Arm1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Unconditional exact method
    param Value
    -4
  2. ci Lower Limit
    2.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    40.7
    group Description
    Difference in response rate Arm3 - Arm1
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Unconditional exact method
    param Value
    22
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        10
    title
    CR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        21
      3. group Id
        OG002
        value
        31
    title
    PR
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    2. group Id
      OG001
      value
      54
    3. group Id
      OG002
      value
      54
    units
    Participants
description
Best overall response is defined as complete response (CR: the disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters \[mm\] in the short axis.) or partial reponse (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]). Participants with unknown or missing responses were considered as non-responders. To be assigned a status of PR or CR, a confirmatory disease assessment should have been performed no less than 28 days after the criteria for response were first met. Response was evaluated by an investigator as per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
groups
  1. description
    Participants received dabrafenib 150 mg gelatin capsules BID.
    id
    OG000
    title
    Part C: Dabrafenib 150 mg
  2. description
    Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
    id
    OG001
    title
    Part C: Dabrafenib 150 mg + Trametinib 1 mg
  3. description
    Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
    id
    OG002
    title
    Part C: Dabrafenib 150 mg + Trametinib 2 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered
reporting Status
POSTED
time Frame
From the first dose of study medication to the first documented evidence of a confirmed complete response or partial response (up to approximately 7 years)
title
Part C (Randomized): Number of Participants With BRAF Mutant Metastatic Melanoma With Best Overall Response as Assessed by the Investigator
type
PRIMARY
unit Of Measure
Participants

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

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