A phase II open-label, multicenter, study to evaluate the efficacy and safety of rivoceranib in subjects with recurrent or metastatic adenoid cystic carcinoma.

Abstract

TPS6597 Background: Adenoid cystic carcinoma (ACC) is a rare salivary gland malignancy, also found in other secretory gland sites (tracheobronchial tree, esophagus, breast, lungs, prostate, uterine cervix and vulva). Initial disease is typically treated with surgical resection and radiation, but recurrent or metastatic disease remain to be a significant challenge. There is no standard systemic therapy option for advanced ACC, although recent studies with tyrosine kinase inhibitors have shown moderate objective response and disease stabilization rates. Rivoceranib (also known as apatinib) is a potent selective inhibitor of VEGFR-2 and has been evaluated in a single arm phase II study of 59 recurrent or metastatic ACC patients in China and has demonstrated an (ORR) of 47.1% and disease control rate of 98.1. Methods: This is a phase II, open-label, multicenter[HGJ3], single arm clinical trial of oral rivoceranib (700 mg daily) in patients with recurrent or metastatic ACC of any anatomic site, not amenable to curative surgery or radiotherapy to confirm activity of rivoceranib. Subjects must have at least one evaluable lesion by RECIST v1.1 and have evidence of disease progression within the 6 months prior to study entry. Fifty-five subjects will be enrolled at 7 US sites and 4 South Korean sites. The primary endpoint is ORR assessed by investigators with a target ORR of 25% to detect a difference of 15% from the historical ORR of 10% at 1-year (this achieves 80% power with a 5% significance level). Secondary endpoints include overall survival, disease control rate, progression free survival at 6, 12 and 24 months and time to progression. Exploratory objectives include correlation between ORR and the presence of MYB/MYB-L1 fusion, pharmacokinetics evaluation, and patient-reported quality of life assessments by FACT-G. This study is open and enrolling at the time of submission.