Continuous vs Intermittent Dabrafenib Plus Trametinib in BRAFV600 Mutant Stage 3 Unresectable or Metastatic Melanoma

Sponsor
Cambridge University Hospitals NHS Foundation Trust
Study ID
NCT03352947
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dabrafenib — DRUG
    150mg Dabrafenib twice daily day 1-21 of 28 day cycle in intermittent arm Day 1-28 of 28 day cycle in continuous arm
  • Trametinib — DRUG
    Trametinib 2mg once daily Day 1-14 of a 28 day cycle in intermittent arm Day 1-28 of a 28 day cycle in the continuous arm

Study Details

This feasibility study aims to determine if intermittent dosing is deliverable, based on patient and professional willingness to take part in a randomised trial evaluating less rather than the standard durations of treatment. The trial will evaluate treatment compliance, Progression Free Survival and Quality of Life, to inform whether a subsequent definitive trial is justified and how it should be designed.

Key Dates

Start date
Nov 3, 2017
Status verified
Dec 2020
Primary completion
Mar 31, 2020
Completion
Nov 27, 2020

Study Design

Enrollment
79 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Continuous (Standard)
    Dabrafenib 150mg twice daily 12 hours apart, on days 1-28 of a 28 day cycle plus Trametinib 2mg once daily, on days 1-28 of a 28 day cycle
  • Experimental: Intermittent (experimental)
    Dabrafenib 150mg twice daily 12 hours apart, on days 1-21 of a 28 day cycle plus Trametinib 2mg once daily, on days 1-14 of a 28 day cycle

Primary Outcome Measure

Recruitment Rate [ Time Frame: To be assessed once the trial has been recruiting for 15 months, or when 15 sites have been open for 6 months whichever is sooner ]

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