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NCT01336634 · OUTCOME

Oral Volume of Distribution (V/F) of Trametinib

Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination With Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer. · Source last updated 2022-04-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
Liter (L)
Interval / dispersion
95% Confidence Interval
Time frame
Week 3, Week 6, Week 12 and Week 18

What was measured

Blood samples from participants were collected for population pharmacokinetic analysis including the oral volume of distribution (V/F) following oral dosing of trametinib. Concentrations of trametinib was determined in plasma samples using the currently approved analytical methodology.

Analysis population: All subjects who received at least one dose of trametinib in the doublets combination (Dabrafenib + Trametinib) Cohort B and C and provided an evaluable PK profile.

Groups in this outcome

Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID

Participants with or without prior systemic anti-cancer therapy received Dabrafenib 150 mg BID until disease progression, death, or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.

Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD

Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received Dabrafenib 150 mg BID and Trametinib 2 mg once daily (OD). Treatment continued until disease progression, death, or unacceptable AEs or investigator discretion to discontinue.

Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD

Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given Dabrafenib 150 mg BID and Trametinib 2 mg OD. Treatment continued until disease progression, death, or unacceptable AEs or at investigator discretion to discontinue.

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

Analysis denominator · Participants

GroupSource count
Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID0
Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD54
Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD30

Reported measurements

Source class 1
Values in Liter (L) · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD91.98Not reported78.58107.66Not reported
Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD103.48Not reported84.58126.59Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        78.58
        upper Limit
        107.66
        value
        91.98
      2. group Id
        OG002
        lower Limit
        84.58
        upper Limit
        126.59
        value
        103.48
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      54
    3. group Id
      OG002
      value
      30
    units
    Participants
description
Blood samples from participants were collected for population pharmacokinetic analysis including the oral volume of distribution (V/F) following oral dosing of trametinib. Concentrations of trametinib was determined in plasma samples using the currently approved analytical methodology.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with or without prior systemic anti-cancer therapy received Dabrafenib 150 mg BID until disease progression, death, or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
    id
    OG000
    title
    Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID
  2. description
    Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received Dabrafenib 150 mg BID and Trametinib 2 mg once daily (OD). Treatment continued until disease progression, death, or unacceptable AEs or investigator discretion to discontinue.
    id
    OG001
    title
    Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD
  3. description
    Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given Dabrafenib 150 mg BID and Trametinib 2 mg OD. Treatment continued until disease progression, death, or unacceptable AEs or at investigator discretion to discontinue.
    id
    OG002
    title
    Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD
param Type
GEOMETRIC_MEAN
population Description
All subjects who received at least one dose of trametinib in the doublets combination (Dabrafenib + Trametinib) Cohort B and C and provided an evaluable PK profile.
reporting Status
POSTED
time Frame
Week 3, Week 6, Week 12 and Week 18
title
Oral Volume of Distribution (V/F) of Trametinib
type
SECONDARY
unit Of Measure
Liter (L)

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

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