Actively Recruiting

Phase 3
Age: 18Years - 70Years
FEMALE
NCT04921527

Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer

Led by Chipscreen Biosciences, Ltd. · Updated on 2024-10-18

454

Participants Needed

1

Research Sites

188 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This randomized, double-blind, 2-arm study will evaluate the efficacy and safety of Chiauranib plus weekly paclitaxel versus placebo plus weekly paclitaxel in patients with Platinum-refractory or Platinum-resistant Recurrent ovarian cancer.

CONDITIONS

Official Title

Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Willingness to sign a written informed consent document .
  • Female, age 60;18 yrs and 60;70 yrs.
  • Histological or cytological confirmation of epithelial ovarian cancer, carcinoma tube, or primary peritoneal carcinoma.
  • Patients with platinum refractory or platinum resistant ovarian cancer:
  • Platinum refractory: progression during the first platinum-based treatment or within 4 weeks after the first platinum-based primary therapy;
  • Platinum resistant: progression during the platinum-based treatment except for platinum refractory, or within 6 months after the last receipt of platinum-based treatment (patients have received platinum containing chemotherapy at least 4 weeks);
  • Radiological progression during the last treatment administered;
  • no more than 1 prior treatment regimens for recurrent disease.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • At least 1 lesion can be accurately measured, as defined by RECIST1.1.
  • Laboratory criteria are as follows:
  • Complete blood count: hemoglobin (Hb) 60;90g/L ; absolute neutrophil count (ANC) 60;1.5�d7109/L ; platelets 60;90�d7109/L;
  • Biochemistry test: serum creatinine(cr) <1.5�d7ULN; total bilirubin<1.5�d7ULN; alanine aminotransferase(ALT) ,aspartate aminotransferase(AST)60;2.5�d7ULN; (ALT,AST605�d7ULN if liver involved) ;
  • Coagulation test: International Normalized Ratio (INR) < 1.5, activeated partial thromboplasting time (APTT) <1.5�d7ULN
  • Life expectancy of at least 3 months.
Not Eligible

You will not qualify if you...

  • Patients received vascular endothelial growth factor(VEGF)/vascular endothelial growth factor receptor(VEGFR) inhibitor, like Apatinib, Anlotinib, Fruquintinib, Bevacizumab, etc., or Aurora kinase inhibitors.
  • Patients received weekly paclitaxel therapy.
  • Has known allegies to Chiauranib, paclitaxel or any of the excipients.
  • Biological therapy, immunotherapy, hormonal therapy within 28 days prior to the first dose of study drug.
  • prior major surgery or trauma within 14 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.
  • clinically significant central/peripheral nervous system disease.
  • 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.
  • primary cardiomyopathy(dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al)
  • History of significant QT interval prolongation, or Corrected QT Interval (QTc) > 470 ms prior to study entry
  • Symptomatic coronary heart disease requiring treatment with agents
  • History of hypertension treated by≥2 agents, or the Blood pressure (Bp) ≥140/90 mmHg prior to study entry.
  • Other condition investigator considered inappropriate
  • Significant intravenous or arterial thrombosis, such as cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
  • History of active bleeding within the past 2 months, patients with bleeding potential during the screening period, or receiving anticoagulation therapy.
  • 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, history of immune-associated pneumonia after treatment of PD1/PDL1 inhibitor.
  • 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 or GI obstruction within the past 3 months.
  • Pleural fluid, ascites or pericardial effusion with significant symptoms or required treatment of puncture or drainage during the screening period, or history of drainage for therapy within 1 months prior to first dose of study drug.
  • Screening for HIV antibody positive.
  • Screening test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with virus replication, hepatitis C antibody (HCV-Ab) positive with virus replication.
  • Active infection requiring oral or intravenous systemic antimicrobial therapy during the screening period.
  • Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or the compliance of study.
  • History of organ transplantation or allo-HSCT.
  • Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or the compliance of study.
  • Candidates with drug and alcohol abuse.
  • Participants of reproductive potential not willing to use adequate contraceptive measures for the duration of the study.Pregnant or breastfeeding women.
  • Any other condition which is inappropriate for the study in the opinion of the investigators.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, China, China, 200032

Actively Recruiting

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Research Team

Y

Yu Chen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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