Chiauranib for Advanced or Unresectable Soft Tissue Sarcoma(STS)

NCT05497843 | Completed Phase 2

• 1 other identifier: CAR204
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2, single-arm, open-label study in patients with advanced or unresectable soft tissue sarcoma.

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival of 12 weeks(PFS12w)

  Proportion of subjects who did not have disease progression or recurrence (according to RECIST1.1) or death from any cause at week 12 after receiving medical treatment

  12 weeks after the first dose

Secondary Outcomes (6)

• Overall response rate (ORR)

  Up to 2 years

• Progression-free survival (PFS)

  Up to 2 years

• Duration of response (DOR)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

Study Arms (1)

Chiauranib capsule

EXPERIMENTAL

Patients take chiauranib capsules 50mg, orally once daily, 21 days as a cycle until objective disease progression

Drug: Chiauranib

Interventions

Chiauranib DRUG

50mg, orally once daily

Also known as: CS2164

Chiauranib capsule

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age ≥ 18 years and ≤75 years.
• Histologically confirmed advanced or unresectable soft tissue sarcoma with failure of standard therapy or no standard therapy.
• At least one measurable target lesion as defined by RECIST1.1, i.e., a lesion that has radiologic evidence of disease progression, after treatment with radiotherapy or local-regional therapy
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Laboratory criteria are as follows:
• Hematology: absolute neutrophil count (ANC) ≥1.5×109/L, platelet ≥75×109/L, hemoglobin ≥80 g/L.
• Biochemistry: serum creatinine \<1.5×upper limit of normal (ULN), total bilirubin ≤1.5×ULN, both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN for patients with hepatic metastasis).
• Coagulation panel: international normalized ratio (INR) \<1.5.
• Life expectancy of at least 3 months.
• Willingness to sign a written informed consent document.

You may not qualify if:

• Active central nervous system (CNS) symptoms during the screening period and/or CNS metastases requiring hormone therapy within 28 days before the first dose, or lesions involving the brain stem or pia mater.
• Imaging during the screening period showed that the tumor had invaded the periphery of the important blood vessels or the investigator judged that the tumor was likely to invade the important blood vessels and cause massive bleeding during the trial.
• Pleural fluid, ascites or pericardial effusion with significant symptoms or required treatment of puncture or drainage during the screening period.
• Current or previous history of other malignancies (other than adequately treated basal or squamous cell carcinoma of the skin or cervical carcinoma in situ) unless curative treatment has been performed and there is no evidence of recurrence or metastasis in the last 5 years
• Prior treatment with vascular endothelial growth factor(VEGF)/vascular endothelial growth factor receptor(VEGFR) inhibitor, like Apatinib, Anlotinib, Fruquintinib, Bevacizumab, etc., or Aurora kinase inhibitors (For patients eligible for anlotinib, only those who could not receive anlotinib for various reasons were allowed to be enrolled in this study. Patients who had previously received anlotinib were excluded from the study).
• Anti-tumor treatments such as radiotherapy, chemotherapy, immunotherapy and targeted therapy were used within 28 days before the first treatment.
• Allergic or contraindicated to any component or vehicle of the test drug.
• Treatment with an investigational agent/instrument within 28 days prior to first dose.
• Prior major surgery or trauma within 28 days prior to first dose and/or presence of any non-healing wound, fracture, or ulcer during the screening period.
• Any ongoing toxicity from prior anti-cancer therapy that is \>Grade 1(except alopecia) during the screening period.
• Uncontrolled or significant cardiovascular disease, including:
• New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina pectoris, myocardial infarction occurred within 6 months before the first dose, or an arrhythmia requiring treatment during the screening period with a left ventricular ejection fraction (LVEF) of \<50%.
• Primary cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy).
• Clinically significant history of QTc interval prolongation, or screening QTc interval \>470ms for women and \>450ms for men.
• Symptomatic coronary heart disease requiring medical treatment during the screening period.

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Sarcoma

Interventions

chiauranib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Xing Zhang, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 11, 2022
• Study Start: August 25, 2022
• Primary Completion: January 3, 2025
• Study Completion: January 3, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)