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 range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.