Dabrafenib With or Without Trametinib in Treating Patients With Advanced Differentiated Thyroid Cancer

Part of paid clinical trials in San Diego, California.

Sponsor
Bhavana Konda
Study ID
NCT01723202
Phase
PHASE2
Status
Completed

Conditions

  • Follicular Thyroid Cancer
  • Insular Thyroid Cancer
  • Papillary Thyroid Cancer
  • Recurrent Thyroid Cancer

Eligibility Criteria

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

Interventions

  • dabrafenib — DRUG
    150 mg orally twice daily given orally
  • trametinib — DRUG
    150 mg orally twice daily and GSK1120212 (MEKi) 2 mg orally once daily given orally

Study Details

This randomized phase II trial studies how well dabrafenib works with or without trametinib in treating patients with recurrent thyroid cancer. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether dabrafenib is more effective when given with or without trametinib in treating thyroid cancer

Key Dates

Start date
Nov 7, 2012
Status verified
Aug 2025
Primary completion
Apr 15, 2022
Completion
Apr 15, 2022

Study Design

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

Arms

  • Experimental: Arm A: GSK2118436
    Patients receive dabrafenib orally 2 twice a day on days 1-28. Patients with disease progression may cross over to arm II.
  • Experimental: Arm B: GSK2118436 and GSK1120212
    Patients receive dabrafenib orally twice a day and trametinib orally once a day on days 1-28.

Primary Outcome Measure

Overall Objective Response Rate, Defined as the Proportion of Patients Who Have a Minor Response (MR), Partial Response (PR), or Complete Response(CR)Assessed According to RECIST. [ Time Frame: up to 24 weeks ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of California, San DiegoSan DiegoCalifornia92093-0698-
University of Chicago Medical CenterChicagoIllinois60637-
Massachusetts General Hospital, Harvard Medical SchoolBostonMassachusetts02114-
Ohio State University Medical CenterColumbusOhio43210-
The University of Texas-MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in San Diego, CA

By research site
University of California, San Diego· San Diego, CAUniversity of Chicago Medical Center· Chicago, ILMassachusetts General Hospital, Harvard Medical School· Boston, MAOhio State University Medical Center· Columbus, OHThe University of Texas-MD Anderson Cancer Center· Houston, TX

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