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NCT01072175 · OUTCOME

Part B: Duration of Response as Assessed by the Investigator in Participants With BRAFi-naïve Mutant Metastatic Melanoma

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
First documented evidence of PR or CR until the earlier of date of disease progression or date of death due to any cause (up to approximately 8 years)

What was measured

Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis.) or 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 \[e.g., percent change from Baseline\]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least 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 (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. BRAFi-naïve participants were those with BRAF-mutation-positive melanoma who had not received prior therapy with a BRAF inhibitor.

Analysis population: All Treated Population. Only those participants who had a CR or PR were analyzed.

Groups in this outcome

Part B: Dabrafenib 75 mg + Trametinib 1 mg

Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.

Part B: Dabrafenib 150 mg + Trametinib 1 mg

Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.

Part B: Dabrafenib 150 mg + Trametinib 1.5 mg

Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.

Part B: Dabrafenib 150 mg + Trametinib 2 mg

Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.

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 B: Dabrafenib 75 mg + Trametinib 1 mg6
Part B: Dabrafenib 150 mg + Trametinib 1 mg22
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg25
Part B: Dabrafenib 150 mg + Trametinib 2 mg24

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part B: Dabrafenib 75 mg + Trametinib 1 mg12.4Not reported3.7NANA: Not estimable due to insufficient number of participants with events
Part B: Dabrafenib 150 mg + Trametinib 1 mg8.4Not reported3.927.4Not reported
Part B: Dabrafenib 150 mg + Trametinib 1.5 mg12.6Not reported5.1NANA: Not estimable due to insufficient number of participants with events
Part B: Dabrafenib 150 mg + Trametinib 2 mg16.9Not reported7.4NANA: Not estimable due to insufficient number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA: Not estimable due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        3.7
        upper Limit
        NA
        value
        12.4
      2. group Id
        OG001
        lower Limit
        3.9
        upper Limit
        27.4
        value
        8.4
      3. comment
        NA: Not estimable due to insufficient number of participants with events
        group Id
        OG002
        lower Limit
        5.1
        upper Limit
        NA
        value
        12.6
      4. comment
        NA: Not estimable due to insufficient number of participants with events
        group Id
        OG003
        lower Limit
        7.4
        upper Limit
        NA
        value
        16.9
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      22
    3. group Id
      OG002
      value
      25
    4. group Id
      OG003
      value
      24
    units
    Participants
description
Duration of response for participants with either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis.) or 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 \[e.g., percent change from Baseline\]) is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression (PD) or death due to any cause. PD is defined as at least 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 (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. BRAFi-naïve participants were those with BRAF-mutation-positive melanoma who had not received prior therapy with a BRAF inhibitor.
dispersion Type
95% Confidence Interval
groups
  1. description
    Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
    id
    OG000
    title
    Part B: Dabrafenib 75 mg + Trametinib 1 mg
  2. description
    Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
    id
    OG001
    title
    Part B: Dabrafenib 150 mg + Trametinib 1 mg
  3. description
    Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
    id
    OG002
    title
    Part B: Dabrafenib 150 mg + Trametinib 1.5 mg
  4. description
    Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
    id
    OG003
    title
    Part B: Dabrafenib 150 mg + Trametinib 2 mg
param Type
MEDIAN
population Description
All Treated Population. Only those participants who had a CR or PR were analyzed.
reporting Status
POSTED
time Frame
First documented evidence of PR or CR until the earlier of date of disease progression or date of death due to any cause (up to approximately 8 years)
title
Part B: Duration of Response as Assessed by the Investigator in Participants With BRAFi-naïve Mutant Metastatic Melanoma
type
SECONDARY
unit Of Measure
Months

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

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