Phase 4 Clinical Trial of Anlotinib for MTC Is Starting Soon

An upcoming study will evaluate the effects of anlotinib hydrochloride as a treatment option for patients with medullary thyroid cancer (MTC).

Researchers have already initiated the recruiting process for this interventional study. This open label, nonrandomized, phase 4 clinical trial will include an approximate of 360 participants previously diagnosed with MTC.

Read more about MTC therapies

The experimental arm will receive a treatment scheme with anlotinib in capsules, in a dosage of 12 mg daily for 2 consecutive weeks, followed by 1 discontinuance week, completing a 21-day cycle. The noninterventional arm consists of prospectively and retrospectively collected data from patients with MTC who did not receive this drug.

This real world research aims to identify and report the efficacy of anlotinib while also observing the safety profile and summarizing the therapeutic experience in a larger sample size. This drug is a multitarget tyrosine kinase inhibitor that leads to impaired angiogenesis while also interfering with tumor cell proliferation in a simultaneous manner.

The overall response rate in up to 3 years, defined as the proportion of participants who exhibit optimal complete or partial response, constitutes 1 of the primary outcomes. The second is progression-free survival, referred to as the period of time between the first dose and either the disease progression or death, whichever happens first.

The investigators will also assess 4 secondary outcomes. The first will be the disease-control rate, comparing the proportion of complete and partial response, as well as a stable disease among the interventional and control groups. The second outcome is the duration of response from the complete or partial response to the disease progression or death. The other outcomes are the overall survival and the adverse event rate.

Individuals of 18 to 75 years of age, of both sexes, with a confirmed diagnosis of inoperable MTC, with a score of 0 to 2 in the Eastern Cooperative Oncology Group Performance Status, and expected survival of 3 months or more, can become part of the sample.

The trial will start in May 2023 and is expected to be completed by December 2028.

Reference

Study of anlotinib in patients with advanced medullary thyroid carcinoma. ClinicalsTrials.gov. Updated April 26, 2023. Accessed May 2, 2023.