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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Ovarian Cancer, Relapsed or Refractory, Chiauranib, Paclitaxel

In brief

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.

Key facts

Study ID: NCT04921527
Run by: Chipscreen Biosciences, Ltd.
People needed: 454
Starts: 2021-12-20
Expected to finish: 2025-07-31
Last updated by the study team: 2024-10-18

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Willingness to sign a written informed consent document .
Female, age ≥18 yrs and ≤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) ≥90g/L ; absolute neutrophil count (ANC) ≥1.5×109/L ; platelets ≥90×109/L;
Biochemistry test: serum creatinine(cr) <1.5×ULN; total bilirubin<1.5×ULN; alanine aminotransferase(ALT) ,aspartate aminotransferase(AST)≤2.5×ULN; (ALT,AST≦5×ULN if liver involved) ;
Coagulation test: International Normalized Ratio (INR) < 1.5, activeated partial thromboplasting time (APTT) <1.5×ULN
Life expectancy of at least 3 months.

You may not qualify if…

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.

Where it is running

Fudan University Shanghai Cancer Center — Shanghai, China, China (enrolling)

Full record on ClinicalTrials.gov

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