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NCT01072175 · OUTCOME

Part D: Number of Participants With the Best Overall Response as Assessed by the Investigator in Participants

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 date of 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 milimeter \[mm\] 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 \[e.g., percent change from Baseline\]). To be assigned a status of PR or CR, a confirmatory disease assessment should be performed no less than 28 days after the criteria for response are first met. Response was evaluated by an investigator as per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

Analysis population: ITT Population

Groups in this outcome

Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg

Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.

Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg

Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.

Part D: Dabrafenib 75 mg + Trametinib 2 mg

Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.

Part D: Dabrafenib 150 mg + Trametinib 2 mg

Participants received dabrefinib 150 mg HPMC 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 D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg12
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg16
Part D: Dabrafenib 75 mg + Trametinib 2 mg43
Part D: Dabrafenib 150 mg + Trametinib 2 mg39

Reported measurements

CR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg0Not reportedNot reportedNot reportedNot reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg2Not reportedNot reportedNot reportedNot reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg5Not reportedNot reportedNot reportedNot reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg7Not reportedNot reportedNot reportedNot reported
PR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg8Not reportedNot reportedNot reportedNot reported
Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg10Not reportedNot reportedNot reportedNot reported
Part D: Dabrafenib 75 mg + Trametinib 2 mg28Not reportedNot reportedNot reportedNot reported
Part D: Dabrafenib 150 mg + Trametinib 2 mg21Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        7
    title
    CR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        28
      4. group Id
        OG003
        value
        21
    title
    PR
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      43
    4. group Id
      OG003
      value
      39
    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 milimeter \[mm\] 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 \[e.g., percent change from Baseline\]). To be assigned a status of PR or CR, a confirmatory disease assessment should be performed no less than 28 days after the criteria for response are 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 dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
    id
    OG000
    title
    Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg
  2. description
    Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
    id
    OG001
    title
    Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg
  3. description
    Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
    id
    OG002
    title
    Part D: Dabrafenib 75 mg + Trametinib 2 mg
  4. description
    Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
    id
    OG003
    title
    Part D: Dabrafenib 150 mg + Trametinib 2 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
ITT Population
reporting Status
POSTED
time Frame
From the date of 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 D: Number of Participants With the Best Overall Response as Assessed by the Investigator in Participants
type
SECONDARY
unit Of Measure
Participants

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

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