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Trial Title:
Chiauranib for Advanced or Unresectable Soft Tissue Sarcoma(STS)
NCT ID:
NCT05497843
Condition:
Soft Tissue Sarcoma
Conditions: Official terms:
Sarcoma
Chiauranib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chiauranib
Description:
50mg, orally once daily
Arm group label:
Chiauranib capsule
Other name:
CS2164
Summary:
This is a Phase 2, single-arm, open-label study in patients with advanced or unresectable
soft tissue sarcoma.
Detailed description:
This single-arm, open-label, multiple-center clinical trial aims to study the efficacy
and safety of chiauranib in the treatment of patients with advanced or unresectable soft
tissue sarcoma, and to explore potential biomarkers associated with chiauranib, as well
as their correlation and clinical benefits.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female, age ≥ 18 years and ≤75 years.
2. Histologically confirmed advanced or unresectable soft tissue sarcoma with failure
of standard therapy or no standard therapy.
3. 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
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
5. Laboratory criteria are as follows:
1. Hematology: absolute neutrophil count (ANC) ≥1.5×109/L, platelet ≥75×109/L,
hemoglobin ≥80 g/L.
2. 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).
3. Coagulation panel: international normalized ratio (INR) <1.5.
6. Life expectancy of at least 3 months.
7. Willingness to sign a written informed consent document.
Exclusion Criteria:
1. 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.
2. 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.
3. Pleural fluid, ascites or pericardial effusion with significant symptoms or required
treatment of puncture or drainage during the screening period.
4. 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
5. 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).
6. Anti-tumor treatments such as radiotherapy, chemotherapy, immunotherapy and targeted
therapy were used within 28 days before the first treatment.
7. Allergic or contraindicated to any component or vehicle of the test drug.
8. Treatment with an investigational agent/instrument within 28 days prior to first
dose.
9. 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.
10. Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1(except
alopecia) during the screening period.
11. Uncontrolled or significant cardiovascular disease, including:
1. 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%.
2. Primary cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyocyte,
arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy).
3. Clinically significant history of QTc interval prolongation, or screening QTc
interval >470ms for women and >450ms for men.
4. Symptomatic coronary heart disease requiring medical treatment during the
screening period.
5. Records of concomitant use of ≥3 antihypertensive drug components within 14
days prior to the first dose, or systolic blood pressure ≥140 mmHg and/or
diastolic blood pressure ≥90 mmHg during the screening period (at rest,
approximately 5 minutes apart, three consecutive measurements, averaged).
6. Previous hypertensive crisis or hypertensive encephalopathy.
7. Other condition investigator considered inappropriate.
12. Chest imaging during the screening period revealed interstitial lung disease or
pulmonary fibrosis or pulmonary inflammation requiring treatment, or a history of
pneumonia treated with oral or intravenous steroids within 6 months before the first
dose.
13. Significant gastrointestinal abnormalities during the screening period that were
judged by the investigator to be likely to interfere with drug intake, transport, or
absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction,
post-small bowel resection, etc.), or total gastrectomy, or a history of
gastrointestinal perforation and/or fistula within 6 months prior to the first dose.
14. 24-hour urine protein quantitative examination must be performed when urine protein
≥2+ in routine urine examination during the screening period. Patients cannot be
enrolled if quantitative urine protein ≥ 1g/24 h.
15. Active bleeding within 2 months before the first dose, or taking anticoagulants
during the screening period (e.g., warfarin, phenprocoumon, and allow prophylactic
use of low-dose aspirin and low-molecular weight heparin), Or investigator judged
that there was a high risk of bleeding during the screening period (such as
esophageal and gastric fundus varices with bleeding risk, locally active ulcer
lesions, positive fecal occult blood could not exclude gastrointestinal bleeding,
intermittent hemoptysis, etc.).
16. A history of deep vein thrombosis or pulmonary embolism or a thrombotic event such
as a cerebrovascular accident within 6 months before the first dose (implantable
venous port or catheter-derived thrombosis, investigator evaluation for enrollment).
17. Active infections that required systemic treatment during the screening period
(oral, intravenous infusion).
18. HIV antibody positive during the screening period.
19. hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive
with virus replication, hepatitis C antibody (HCV-Ab) positive with virus
replication during the screening period.
20. Any mental or cognitive impairment that may limit the understanding, execution, and
adherence to the study.
21. Drug use and long-term alcohol abuse affected the evaluation of test results.
22. Pregnant or lactating women; Be unwilling or unable to during the treatment of this
test and test the last 12 weeks after the treatment using effective methods of
contraception among women of reproductive age [women of childbearing age include:
did not receive any had menstruation and successful artificial sterilization
(hysterectomy and bilateral tubal ligation or bilateral oophorectomy) or
menstruating]; If the partner is a woman of childbearing age, the subject is a
fertile man who is not using effective contraception.
23. Other conditions considered by the investigator to be inappropriate for trial
participation, such as concomitant disease, concomitant therapy, or any laboratory
abnormality, may interfere with the evaluation of efficacy and safety results.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Start date:
August 2, 2022
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Chipscreen Biosciences, Ltd.
Agency class:
Industry
Source:
Chipscreen Biosciences, Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05497843