Participant flow

A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma · Source last updated 2021-02-17

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

groups

1. description

   Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.

   id

   FG000

   title

   Dabrafenib + Trametinib

2. description

   Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Crossover to the combination therapy arm was allowed for subjects still receiving study treatment on the dabrafenib monotherapy arm after the positive result for the final OS analysis.

   id

   FG001

   title

   Dabrafenib + Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         136

      2. group Id

         FG001

         num Subjects

         146

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         9

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      type

      Investigator discretion

   4. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         4

      type

      Withdrew consent

   5. reasons

      1. group Id

         FG000

         num Subjects

         50

      2. group Id

         FG001

         num Subjects

         23

      type

      Study closed/terminated

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         28

      type

      Crossover to Dabrafenib + Trametinib

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         211

      2. group Id

         FG001

         num Subjects

         212

      comment

      All randomized patients included into Intent-to-Treat (ITT) population.

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         209

      2. group Id

         FG001

         num Subjects

         211

      comment

      All patients who received at least one dose of study treatment

      type

      Safety Set

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         28

      comment

      All monotherapy randomized patients who crossed over to combination therapy

      type

      Crossover Population

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         211

      2. group Id

         FG001

         num Subjects

         212

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Approximately, 340 subjects were planned to be randomized in a 1:1 ratio (170 subjects each in combination therapy and monotherapy). A total of 423 subjects with unresectable or metastatic, BRAF V600E or V600K mutation-positive melanoma were randomized to dabrafenib and trametinib (n=211) or dabrafenib and placebo (n=212).

recruitment Details

This study was conducted in 103 centers in 14 countries worldwide: Argentina (1), Australia (6), Canada (5), France (8), Germany (25), Greece (3), Italy (8), Netherlands (3), Russia (4), Spain (7), Sweden (4), Ukraine (7), United Kingdom (10), and USA (12).

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

Preserved source evidence · Not medical advice