Design of the ANAPLAST-NEO Study for Anaplastic Thyroid Cancer

Yuliya Mikheeva, MD, PhD, discusses the design of the phase 2 ANAPLAST-NEO study

Yuliya Mikheeva, MD, PhD, of Saint-Petersburg State University, discusses the design of the phase 2 ANAPLAST-NEO study (NCT04739566).

The open-label, single-arm, non-randomized study looks to test the efficacy of the combination of dabrafenib (Tafinlar), a BRAF inhibitor, and a MEK inhibitor as a neoadjuvant strategy in BRAF-positive anaplastic thyroid cancer (ATC). Currently, the study has an estimated enrollment of 18 participants, and an estimated primary completion date of January, 2024.

Eligibility in the trial was open to patients with histologically confirmed disease BRAF-positive ATC with the absence of metastases in the brain, as well as normal organ and bone marrow function.

Primary end points of the trial include overall response rate and the number of R0 resections after 3 months of neoadjuvant combination therapy with anti-BRAF and MEK inhibitors. The secondary end points being studied consist of safety, complete response rate, health-related quality of life, progression-free survival, and overall survival.

Transcription:

0:08 | It's a phase 2 single-center, open-label, single-arm, non-randomized study. Our primary end points are objective response rate, and number of 0 resections after 3 months of neoadjuvant combination therapy with anti-BRAF and MEK inhibitors. Secondary end points are safety profile, health-related quality of life, progression- free survival, and overall survival.

0:56 | The inclusion criteria is any male or female that are over 18 years or years old, and in good performance status. Patients must have histologically confirmed disease, BRAF-positive anaplastic thyroid cancer, determined by immunohistochemistry of the presence of BRAF with a V600E mutation in tumor tissue, they must have the ability of swallow tablets and capsules or gastrectomy, the absence of metastases in the brain and normal organ and bone marrow function.