Rivoceranib in Patients With Metastatic Thymic Epithelial Tumor (NCT06200233) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Rivoceranib in Patients With Metastatic Thymic Epithelial Tumor
South Korea40 participantsStarted 2024-05-01
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. 19 years of age or older at the time of signing informed consent
✓. Subjects with histologically confirmed metastatic thymic epithelial tumor
✓. Have at least one measurable target lesion for evaluation according to RECIST v1.1 criteria
✓. Patients who are not candidates for surgery and require consolidation chemotherapy
✓. Radiologic progression of disease after first-line standard therapy
✓. ECOG performance status of 0 or 1
✓. Life expectancy greater than 3 months
✓. Patients with adequate bone marrow and organ function \[Bone marrow function\]
Exclusion criteria
✕. Patients with more than 22 concurrent tumors and/or other active malignancies requiring systemic treatment within the last 22 years at the time of the first dose of investigational drug (however, patients may participate in the study if the principal investigator determines that the previous malignancy has been treated and no further treatment is required).
✕. Patients treated with a previous anti-angiogenic agent (ex. Sunitinib, bevacizumab etc)
✕. Patients with difficult to control central nervous system metastases
✕. Those with spinal cord compression, leptomeningeal carcinomatosis
✕. Patients with uncontrolled systemic disease, including uncontrolled hypertension, active bleeding, or active infection.
✕. Unresolved toxicities from prior therapy greater than or equal to grade 1 based on CTCAE version 5.0.
✕. Received extensive radiotherapy within the last 2 weeks, or received localized radiotherapy or gamma knife surgery with a limited scope of radiotherapy for palliative purposes within the last 1 week.
✕. Unable to swallow investigational medication due to intractable nausea and vomiting or chronic gastrointestinal disease.