A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01584648
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This was a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib and trametinib combination therapy to dabrafenib administered with a placebo (dabrafenib monotherapy). Subjects with histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV, and BRAF V600E/K mutation positive were screened for eligibility. Subjects who had prior systemic anti-cancer treatment in the advanced or metastatic setting were not eligible although prior systemic treatment in the adjuvant setting was allowed. Subjects were stratified according to the baseline lactate dehydrogenase level and BRAF genotype.

Key Dates

Start date
May 4, 2012
Status verified
Feb 2021
Primary completion
Aug 26, 2013
Completion
Feb 28, 2019

Study Design

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

Arms

  • Experimental: Dabrafenib + Trametinib
    Dabrafenib and Trametinib combination
  • Active Comparator: Dabrafenib + Placebo
    Dabrafenib and Trametinib placebo

Primary Outcome Measure

Progression-Free Survival (PFS) as Assessed by the Investigator [ Time Frame: From randomization until the earliest date of disease progression (PD) or death due to any cause (up to approximately 6 years) ]

Locations (19)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteScottsdaleArizona85258-
Novartis Investigative SiteTucsonArizona85719-
Novartis Investigative SiteLos AngelesCalifornia90024-
Novartis Investigative SiteFort MyersFlorida33916-
Novartis Investigative SiteSt. PetersburgFlorida33705-
Novartis Investigative SiteTampaFlorida33612-
Novartis Investigative SiteWest Palm BeachFlorida33401-
Novartis Investigative SitePeoriaIllinois61615-7822-
Novartis Investigative SiteIndianapolisIndiana46202-
Novartis Investigative SiteBostonMassachusetts02114-
Novartis Investigative SiteBostonMassachusetts02215-
Novartis Investigative SiteNew YorkNew York10065-
Novartis Investigative SiteCincinnatiOhio45242-
Novartis Investigative SitePhiladelphiaPennsylvania19104-
Novartis Investigative SiteColumbiaSouth Carolina29210-
Novartis Investigative SiteChattanoogaTennessee37404-
Novartis Investigative SiteNashvilleTennessee37203-
Novartis Investigative SiteFort WorthTexas76104-
Novartis Investigative SiteRichmondVirginia23230-

Find similar trials in Scottsdale, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Novartis Investigative Site· Scottsdale, AZNovartis Investigative Site· Tucson, AZNovartis Investigative Site· Los Angeles, CANovartis Investigative Site· Fort Myers, FLNovartis Investigative Site· St. Petersburg, FLNovartis Investigative Site· Tampa, FL

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