Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02034110
Phase
PHASE2
Status
Completed

Conditions

  • Cancer

Eligibility Criteria

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

Interventions

  • Dabrafenib — DRUG
    A 150 mg twice daily capsule administered orally on a continuous basis.
  • Trametinib — DRUG
    A 2 mg once daily tablet administered orally on a continuous basis.

Study Details

This was a Phase II, open-label, non-randomized, multi-center study of oral dabrafenib in combination with oral trametinib in subjects with rare cancers harboring the BRAF V600E mutation including anaplastic thyroid cancer (ATC), biliary tract cancer (BTC), gastrointestinal stromal tumor (GIST), low grade (WHO G1/G2) glioma (LGG), high grade (WHO G3/G4) glioma (HGG), non-seminomatous germ cell tumors (NSGCT) / non-germinomatous germ cell tumors (NGGCT), adenocarcinoma of the small intestine (ASI), hairy cell leukemia (HCL) and multiple myeloma (MM).

Key Dates

Start date
Mar 12, 2014
Status verified
Jul 2023
Primary completion
Dec 10, 2021
Completion
Dec 10, 2021

Study Design

Enrollment
206 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dabrafenib + Trametinib
    Subjects received Dabrafenib 150 mg twice daily orally plus Trametinib 2 mg once daily orally on a continuous basis. Dabrafenib was administered under fasted conditions, either 1 hour (hr) before or 2 hours (hrs) after a meal with approximately 200 mL of water with an interval of 12 hours. Trametinib was administered under fasted conditions, either 1 hr before or 2 hrs after a meal with approximately 200 mL of water. Subjects took their dose of Trametinib concurrently with the morning dose of Dabrafenib. A treatment cycle was 28 days in duration. Subjects continued treatment until an unacceptable toxicity, disease progression, or death occurs.

Primary Outcome Measure

Overall Response Rate (ORR) in the Anaplastic Thyroid Cancer (ATC) Cohort [ Time Frame: From study treatment start date until first documented complete response or partial response, assessed up to 78 months (cut-off date for FDA Submission = 14-Sep-20) and up to 92 months (cut-off date for end of study = 10-Dec-21) ]

Locations (8)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteLittle RockArkansas72205-
Novartis Investigative SiteSanta MonicaCalifornia90404-
Novartis Investigative SiteBethesdaMaryland20892-
Novartis Investigative SiteBostonMassachusetts02114-
Novartis Investigative SiteBostonMassachusetts02215-
Novartis Investigative SiteNew YorkNew York10016-
Novartis Investigative SiteNashvilleTennessee37203-
Novartis Investigative SiteHoustonTexas77030-

Find similar trials in Little Rock, AR

By research site
Novartis Investigative Site· Little Rock, ARNovartis Investigative Site· Santa Monica, CANovartis Investigative Site· Bethesda, MDNovartis Investigative Site· Boston, MANovartis Investigative Site· New York, NYNovartis Investigative Site· Nashville, TN

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