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New treatment option for Ovarian Cancer
Official title Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer
ClinicalTrials.gov ID: NCT04921527
What this study is testing
What is chiauranib?
chiauranib is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for ovarian cancer.
Also referred to as CS2164.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join 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;
You likely can't join if
- Patients received vascular endothelial growth factor(VEGF)/vascular endothelial growth factor receptor(VEGFR) inhibitor, like Apatinib, Anlotinib...
- 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.
See the full eligibility criteria
Who can join
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.