Rivoceranib in Patients With Metastatic Thymic Epithelial Tumor

NCT06200233 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2023-09-121
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Thymic Epithelial Tumor

Outcome Measures

Primary Outcomes (1)

• Objective response rate(ORR) Objective response rate(ORR)

  6 month after completion of enrollment

Secondary Outcomes (3)

• Progression-free survival(PFS)

  up to 30 months

• Disease control rate(DCR)

  up to 30 months

• Duration of response(DOR)

  up to 30 months

Other Outcomes (2)

• Exploratory biomarker analysis

  up to 30 months

• Exploratory biomarker analysis

  up to 30 months

Study Arms (1)

single arm

EXPERIMENTAL

Rivoceranib 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.

Drug: Rivoceranib

Interventions

Rivoceranib DRUG

700mg once daily

single arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[Bone marrow function\]
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

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

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Thymic epithelial tumor

Interventions

apatinib

Central Study Contacts

Myung-Ju Ahn

CONTACT

821034103438; silkahn@skku.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Professor

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 10, 2024
• Study Start: May 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

KR (1)