Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06200233
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2023-12-28
Brief Title:
Rivoceranib in Patients With Metastatic Thymic Epithelial Tumor
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
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
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 inclusionexclusion 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 productRivoceraniv 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 v11 criteria Safety will be assessed at C1D1 C1D7 and each scheduled visit thereafter
Study Design Patients with histologically confirmed metastatic thymic epithelial tumors who meet the inclusionexclusion 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 productRivoceraniv 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 v11 criteria Safety will be assessed at C1D1 C1D7 and each scheduled visit thereafter
Detailed 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 015 cases per 100000 people per year in the United States and 17 cases per 1000000 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 PaclitaxelCarboplatin 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None