Rivoceranib in Patients With Metastatic Thymic Epithelial Tumor

Thymic Epithelial Tumor Clinical Trial

Official title: A Phase II, Open-label, Single-arm, Multi-center Clinical Trial of Rivoceranib in Patients With Metastatic Thymic Epithelial Tumor

Status Not yet recruiting

Clinical Trial Summary

PURPOSE: To evaluate the efficacy and safety of Rivoceranib in patients with metastatic thymic epithelial tumors who developed resistance on first-line therapy.

Study Design: Patients with histologically confirmed metastatic thymic epithelial tumors who meet the inclusion/exclusion criteria will be enrolled in this study. In Stage 1, 18 subjects will be enrolled to receive study medication. If a tumor response is observed in at least 5 of these subjects, the study will proceed to Stage 2 to enroll the remaining subjects, or the study will be stopped early due to lack of clinical benefit of the investigational product. The trial will be considered clinically valid if a response is observed in 11 or more subjects out of a total of 33 subjects. Investigational product(Rivoceraniv 700 mg) will be administered until disease progression, development of intolerable adverse events, death, withdrawal of consent by the subject, or when, in the opinion of the principal investigator, it is inappropriate or impossible to continue the study. Imaging studies (CT or MRI) will be performed every 8 weeks (+,- 1 week) for C1D1 through 12 months and every 12 weeks (+,- 1 week) after 12 months, and the results will be used to assess tumor response according to RECIST v1.1 criteria. Safety will be assessed at C1D1, C1D7, and each scheduled visit thereafter.

Clinical Trial Description

Thymic epithelial tumors (TET) are tumors of the thymus gland, which plays a pivotal role in adaptive immunity, and are classified as thymoma, thymic carcinoma, and thymic neuroendocrine tumor. Although it is the most common neoplasm of the anterior mediastinum, it is a rare cancer with an incidence of 0.15 cases per 100,000 people per year in the United States and 1.7 cases per 1,000,000 people per year in Europe. For surgically inoperable thymic epithelial tumors, first-line treatment is based on cytotoxic anticancer drugs. In this case, combinations such as Paclitaxel/Carboplatin or Cyclophosphamide, Adriamycin, Cisplatin (CAP) are mainly used as first-line treatment, but their therapeutic effect is still limited to less than 40%, and they also have very high toxicity. In the event of resistance to first-line therapy, there are a number of treatment options available, including Sunitinib, Pemetrexed, Everolimus, Paclitaxel, Gemcitabine based regimens, Lenvatinib, and Pembrolizumab. Lenvatinib, a representative agent with a similar mechanism of action to rivoceranib, has also shown excellent clinical results in thymic epithelial tumors. Lenvatinib, which targets various kinases in addition to the Vascular Endothelial Growth Factor Receptor (VEGFR), was used in a total of 42 patients, resulting in a partial response in 38% of patients and stable disease in 57% of patients. Rivoceranib is a selective inhibitor of VEGFR-2 and is currently approved and marketed in China for the treatment of gastric and liver cancer. Rivoceranib has similar targets to Lenvatinib and Sunitinib, and this study is expected to show clinical benefits when used in thymic epithelial tumors (TET), providing additional treatment opportunities for patients in the absence of targeted therapies currently covered by domestic insurance in the second-line setting. ;

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Thymic Epithelial Tumor
• Thymus Neoplasms

• NCT number: NCT06200233
• Study type: Interventional
• Source: Samsung Medical Center
• Contact: Myung-Ju Ahn
• Phone: 821034103438
• Email: silkahn@skku.edu
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Completion date: December 1, 2026