Dabrafenib, Trametinib, and IMRT in Treating Patients With BRAF Mutated Anaplastic Thyroid Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT03975231
Phase
PHASE1
Status
Recruiting

Conditions

  • BRAF NP_004324.2:p.V600E
  • BRAF V600K Mutation Present
  • Thyroid Gland Anaplastic Carcinoma

Eligibility Criteria

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

Interventions

  • Dabrafenib — DRUG
    Given PO
  • Intensity-Modulated Radiation Therapy — RADIATION
    Undergo IMRT
  • Trametinib — DRUG
    Given PO

Study Details

This trial studies how well dabrafenib, trametinib, and intensity modulated radiation therapy (IMRT) work together in treating patients with BRAF mutated anaplastic thyroid cancer. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving dabrafenib, trametinib, and IMRT together may kill more tumor cells.

Key Dates

Start date
Sep 14, 2020
Status verified
Apr 2026
Primary completion
Oct 5, 2027
Completion
Oct 5, 2027

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (dabrafenib, trametinib, IMRT)
    See Detailed Description

Primary Outcome Measure

Maximum tolerated dose of combination therapy of dabrafenib and trametinib administered concurrently with intensity-modulated radiation therapy (IMRT) [ Time Frame: 1 year ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Sasan M. Fazeli, MD
626-218-2332
Sasan Fazeli, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Manisha H. Shah, MD
614-366-6994
Manisha H. Shah, MD (PRINCIPAL_INVESTIGATOR)
Univ of Texas-M.D. Anderson Cancer CenterHoustonTexas77030
Naifa Busaudy, MD
713-792-2841

Find similar trials in Duarte, CA