Vemurafenib Neoadjuvant Trial in Locally Advanced Thyroid Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

November 7, 2012

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Thyroid Cancer
Interventions
DRUG

Vemurafenib (All Groups)

960 mg by mouth 2 times a day 56 days prior to surgery (patients not planned for surgical resection will have a core biopsy at day 56.

DRUG

Vemurafenib (Post Surgery) - Group A + C

"Group A: 960 mg by mouth twice a day 2 weeks post-surgery. Restaged 8 weeks after resuming drug. If patients demonstrate either stable or regressing disease, they will continue on vemurafenib with restaging occurring every 8 weeks until they are no longer benefitting from the drug.~Group C: Patients not scheduled for surgical resection undergo a CT scan and core biopsy at day 56. Vemurafenib 960 mg by mouth twice a day, continued unless there is evidence of progressive disease on day 56 CT scan. Patients restaged every 8 weeks and continue vemurafenib until no longer benefitting from the drug. Patients evaluated for resectability after each CT scan is performed. If patient is scheduled for resection, then patient will continue vemurafenib until surgery and will follow the same treatment schema as patients in Groups A and B."

OTHER

Post Surgery - Group B

Patients who have had a complete surgical resection, and who do not have evidence of metastatic disease will discontinue vemurafenib after surgery. Patients restaged with CT neck 8 weeks after surgery.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT01709292 - Vemurafenib Neoadjuvant Trial in Locally Advanced Thyroid Cancer | Biotech Hunter | Biotech Hunter