Overview

A Phase II Study of Chiauranib in Combine With Capecitabine in TNBC

Status:
Recruiting
Trial end date:
2024-08-09
Target enrollment:
0
Participant gender:
Female
Summary
This study is to evaluate the preliminary efficacy and safety of chiauranib in combine with capecitabine in advanced triple-negative breast cancer failed to prior anthracyclines and taxanes therapy
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chipscreen Biosciences, Ltd.
Treatments:
Capecitabine
Chiauranib
Criteria
Inclusion Criteria:

1. All patients must have given signed, informed consent prior to registration on study

2. age ≥ 18 years

3. female

4. Histological or cytological evidence of estrogen-receptor negative (ER-), progesterone
receptor negative (PgR-) and human epidermal growth factor-2 receptor negative (HER2-)
Breast Cancer by local laboratory testing.

5. Patients with locally advanced inoperable or recurrent/metastatic TNBC and had failed
treatment with anthracyclines and taxanes.

6. At least 1 lesion can be accurately measured, as defined by RECIST1.1

7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

8. Laboratory criteria are as follows:

1) Complete blood count: hemoglobin (Hb) ≥90g/L ; absolute neutrophil count (ANC)
≥1.5×109/L ; platelets ≥90×109/L; 2) Biochemistry test: serum creatinine(cr) <1.5×ULN;
total bilirubin<1.5×ULN; alanine aminotransferase(ALT)
,aspartateaminotransferase(AST)≤2.5×ULN; (ALT,AST#5×ULN if liver involved) 3) Coagulation
test: International Normalized Ratio (INR) < 1.5

9. Life expectancy of at least 3 months

Exclusion Criteria:

1. Patients have used any anti-cancer therapy, including adiotherapy, chemotherapy,
immunotherapy, target therapy, and other anti-tumor treatments within 28 days before
the first dose

2. Patients received vascular endothelial growth factor(VEGF)/vascular endothelial growth
factor receptor(VEGFR) inhibitor, like Apatinib, Anlotinib, Fruquintinib, Bevacizumab,
etc., or Aurora kinase inhibitors, etc; Patients had treatment of capecitabine (except
who received the treatment of capecitabine in Neoadjuvant/ Adjuvant therapy, and
Recurrence occurs after 12 months)

3. Has known allegies to Chiauranib, capecitabine or any of the excipients

4. prior major surgery or trauma within 28 days prior to first dose of study drug and/or
presence of any non-healing wound, fracture, or ulcer

5. Treatment with an investigational agent/instrument within 28 days prior to first dose
of study drug

6. Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1

7. Patients with prior invasive malignancies in the past five years with the exception of
curatively-treated basal cell or squamous cell carcinoma of the skin or cervical
carcinoma in situ

8. History or clinical evidence of central nervous system (CNS) metastases or
leptomeningeal carcinomatosis

9. Have uncontrolled or significant cardiovascular disease, including:

1) Congestive heart failure, unstable angina pectoris, myocardial infarction within 6
months prior to study entry; arrhythmia, or Left Ventricular Ejection Fraction (LVEF) < 50%
requiring treatment with agents during screening stage 2) primary cardiomyopathy(dilated
cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular
cardiomyopathy, restrictive cardiomyopathy, et,al) 3) History of significant QT interval
prolongation, or Corrected QT Interval (QTc) > 470 ms prior to study entry 4) Symptomatic
coronary heart disease requiring treatment with agents 5) History of hypertension treated
by≥2 agents, or the Blood pressure(Bp) ≥140/90 mmHg prior to study entry 6) Other condition
investigator considered inappropriate

10. CT or MRI of the chest during the screening period shows interstitial lung disease or
pulmonary fibrosis or lung inflammation that requires treatment, or within 6 months before
the first dose, history of pneumonia requiring oral or intravenous steroid treatment

11. Have clinical significant gastrointestinal abnormality that would impair the ingestion,
transportation or absorption of oral agents, history of gastrointestinal perforation or
abdominal fistula, peptic ulcer disease within 6 months prior to first dose of study drug

12. Urinary protein ≥ 2+ and quantitative urinary protein ≥ 1g/24 h during the screening
period

13. History of active bleeding within the past 2 months, patients with bleeding potential
during the screening period, or receiving anticoagulation therapy

14. Pleural fluid, ascites or pericardial effusion with significant symptoms or required
treatment of puncture or drainage during the screening period

15. History of deep venous thrombosis or Pulmonary embolism within the past 6 months

16. Active infection requiring oral or intravenous systemic antimicrobial therapy during
the screening period

17. Screening for HIV antibody positive

18. Screening test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody
(HBcAb) positive with virus replication, hepatitis C antibody (HCVAb) positive with virus
replication

19. Any mental or cognitive disorder, that would impair the ability to understand the
informed consent document, or the compliance of study

20. Candidates with drug and alcohol abuse

21. Participants of reproductive potential not willing to use adequate contraceptive
measures for the duration of the study.Pregnant or breastfeeding women

22. Any other condition which is inappropriate for the study in the opinion of the
investigators