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Thymic Epithelial TumorPhase 2NCT06200233

Rivoceranib in Patients With Metastatic Thymic Epithelial Tumor

A Phase 2 study testing Rivoceranib in people with Thymic Epithelial Tumor, run by Samsung Medical Center at 1 site in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Thymic Epithelial Tumor
What is being tested?
Rivoceranib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSouth Korea
Study dates
1 May 2024to 1 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • Life expectancy greater than 3 months
  • Patients with adequate bone marrow and organ function [Bone marrow function]
  • Neutrophils (ANC) > 1,500/mm3
  • Platelets > 100,000/mm3
  • Hemoglobin > 9 g/dL [Liver function]
  • Total bilirubin ≤ 1.5 x upper limit of normal (if liver metastases are present, up to 3 x upper limit of normal is allowed)
  • AST, ALT ≤ 3 x upper limit of normal (if liver metastases are present, up to 5 x upper limit of normal is allowed) [Renal function]
  • Creatinine clearance > 50 mL/min (Cockcroft-Gault equation)
  • Subjects who have voluntarily decided to participate in this study and have given written informed consent and are able to participate in all periods of the study.

Who cannot join

  • 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.
  • However, individuals with the following hepatitis B/C infections may be enrolled
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  • Hepatitis B surface antigen (HBsAg) positive, with an ALT in the normal range and HBV DNA <2,000 IU/ml, and taking antiviral therapy to prevent hepatitis reactivation may be enrolled.
  • HBs Ag negative, hepatitis B core antibody (IgG anti-HBc) positive, and HBV DNA below the lower limit of quantification may be enrolled.
  • Anti-HCV Ab positive individuals can be enrolled if HCV RNA is the lower limit of quantification.
  • 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.
  • Participation in another interventional clinical trial within 30 days of screening
  • Pregnant or lactating women
  • Unwilling to agree to use a medically acceptable method of contraception from the first dose of investigational drug until 1 month after the last dose.
  • Female patients of childbearing potential who are sexually active and their partners must agree to use adequate medically acceptable contraception for the duration of the study and for 1 month after the last dose.
  • Male patients who have not undergone a vasectomy must agree to use adequate contraception and are prohibited from providing sperm until 1 month after the last dose of study medication.
  • Adequate contraception includes: hormonal contraceptives (subcutaneous fat, injections, oral contraceptives, etc.), intrauterine devices (IUD, intrauterine device or IUS, intrauterine system), sterilization of you or your partner (vasectomy, tubal ligation, etc.).
  • Failure to provide 20 unstained slides (if additional biopsies are not available from the patient, participation in the study may be possible after discussion with the study coordinator).
  • Those who are inappropriate to participate in the study for other reasons (e.g., ethically or because it may affect the outcome of the study) as judged by the principal investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Myung-Ju Ahn contact

821034103438

silkahn@skku.edu

South Korea1 site

  • Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

    Seoul, 135-710

Other trials in South Korea

About this study

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

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.

Read the 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 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.

Being tested
Rivoceranib
Medical subject headings
Thymic epithelial tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RivoceranibDrug

    700mg once daily

Study groups in NCT06200233
Study groupRoleWhat they receive
single armExperimentalRivoceranib 700 mg once daily by mouth. Rivoceranib should be given at the same time each day, with or without meals. Swallow the tablet whole. Do not chew, crush, or split the tablet. Receive study medication until there is evidence of disease progression, intolerable toxicity, withdrawal of consent by the patient, or in the judgment of the principal investigator that the study cannot continue due to inability to administer. Tumor response will be assessed according to RECIST v1.1 criteria based on imaging studies (CT or MRI) measured every 8 weeks (±1 week) from C1D1 through 12 months and every 12 weeks (±1 week) after 12 months.
Receives: Drug: Rivoceranib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate(ORR) Objective response rate(ORR)

    Measured: 6 month after completion of enrollment

Secondary outcomes (3)

  1. Progression-free survival(PFS)

    Measured: up to 30 months

  2. Disease control rate(DCR)

    Measured: up to 30 months

  3. Duration of response(DOR)

    Measured: up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2024
  2. Study start1 May 2024 (estimated)
  3. Primary completion1 Mar 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06200233
Sponsor's protocol ID
2023-09-121
Status last verified
Apr 2024
First submitted
28 Dec 2023
Last updated
9 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rivoceranib in people with Thymic Epithelial Tumor, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Myung-Ju Ahn (821034103438, silkahn@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate(ORR) Objective response rate(ORR) (time frame: 6 month after completion of enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06200233.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.

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