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

NCT05336721 | Terminated Phase 2 DMC

• 1 other identifier: CAR202
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Triple-negative Breast Cancer

Keywords

Chiauranib；Capecitabine；triple-negative breast cancer

Outcome Measures

Primary Outcomes (1)

• ORR(Objective reponse rate)

  Overall response rate (ORR) is defined as the percentage of patients with complete or partial response evaluated by RECIST 1.1. Per RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  2years

Secondary Outcomes (5)

• CBR (Clinical Benefit Rate)

  2years

• PFS (Progression-free survival)

  2years

• DoR (Duration of response)

  2years

• OS(Overall survival)

  2years

• AEs

  2years

Study Arms (1)

Experimental: Chiauranib + capecitabine

EXPERIMENTAL

Patients receive the combined treatment of Chiauranib plus capecitabine, 21 days as a cycle until objective disease progression.

Drug: Chiauranib; Drug: capecitabine

Interventions

Chiauranib DRUG

25mg/35mg/50mg orally once daily

Experimental: Chiauranib + capecitabine

capecitabine DRUG

1000mg/m2 on Days 1-14 in a repeating 21-day cycle

Experimental: Chiauranib + capecitabine

Eligibility Criteria

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

You may qualify if:

• All patients must have given signed, informed consent prior to registration on study
• age ≥ 18 years
• female
• 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.
• Patients with locally advanced inoperable or recurrent/metastatic TNBC and had failed treatment with anthracyclines and taxanes.
• At least 1 lesion can be accurately measured, as defined by RECIST1.1
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Laboratory criteria are as follows:
• \) 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
• \. Life expectancy of at least 3 months

You may not qualify if:

• 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
• 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)
• Has known allegies to Chiauranib, capecitabine or any of the excipients
• 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
• Treatment with an investigational agent/instrument within 28 days prior to first dose of study drug
• Any ongoing toxicity from prior anti-cancer therapy that is \>Grade 1
• 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
• History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis
• Have uncontrolled or significant cardiovascular disease, including:
• \) 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
• \. 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
• \. 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
• \. Urinary protein ≥ 2+ and quantitative urinary protein ≥ 1g/24 h during the screening period
• \. History of active bleeding within the past 2 months, patients with bleeding potential during the screening period, or receiving anticoagulation therapy
• \. Pleural fluid, ascites or pericardial effusion with significant symptoms or required treatment of puncture or drainage during the screening period

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (4)

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 8 Fengtai East Street, Fengtai, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

chiauranib; Capecitabine

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

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

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: April 20, 2022
• Study Start: November 5, 2021
• Primary Completion: October 31, 2024
• Study Completion: November 5, 2024
• Last Updated: March 24, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)