A Prospective, Single-arm, Multicenter, Exploratory Phase II Study to Evaluate the Efficacy and Safety of Anlotinib Combined With Carboplatin/Paclitaxel as First-line Treatment in Patients With Advanced Ovarian Cancer

Wenjun Cheng6 sites in 1 country56 target enrollmentAugust 24, 2021

ConditionsOvarian Neoplasms Fallopian Tube Neoplasms Neoplasms by Site Genital Neoplasms, Female Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma, Ovarian Epithelial Ovarian Diseases Genital Diseases, Female Endocrine System Diseases Carcinoma Anlotinib Angiogenesis Antineoplastic Agents Tyrosine Kinase Inhibitor

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Ovarian Neoplasms
Sponsor: Wenjun Cheng
Enrollment: 56
Locations: 6
Primary Endpoint: Progression Free Survival (PFS)
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

It has been reported that antiangiogenic drugs combined with chemotherapy as first-line treatment, and subsequent antiangiogenic drugs as maintenance therapy for ovarian cancer can achieve better clinical benefits. Therefore, this study is expected to investigate the efficacy and safety of anlotinib combined with carboplatin/paclitaxel as first-line treatment in patients with advanced ovarian cancer.

Detailed Description

This study is a single-arm, multicenter, exploratory phase II study to observe the efficacy and safety of anlotinib combined with carboplatin/paclitaxel as first-line treatment in patients with advanced ovarian cancer. The primary end point are progression free survival; the secondary end points include objective response rate, disease control rate, overall survival and safety. The subjects in this study: patients with newly diagnosed advanced (FIGO stage III-IV) ovarian cancer, including histologically or pathologically confirmed high-grade serous ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma

Registry

clinicaltrials.gov

Start Date

August 24, 2021

End Date

December 31, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Wenjun Cheng

Responsible Party

Sponsor Investigator

Principal Investigator

Wenjun Cheng

Director, Head of Gynecology

The First Affiliated Hospital with Nanjing Medical University

Eligibility Criteria

Inclusion Criteria

•Subjects must be female ≥18 years old;
•Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1；
•Postoperative administration time: within 12 weeks after the maximum tumor reduction operation;
•Histologically or pathologically confirmed advanced (FIGO stage III - IV) ovarian cancer, fallopian tube cancer, or primary peritoneal cancer；
•Subjects have enough organ function: (1) Blood routine(without blood transfusion or hematopoietic stimulating factor within 7 days before screening ): a.Hemoglobin (HB)≥9.0g/L; b.Absolute value of neutrophil (ANC)≥1.5 \* 10\^9 / L; c.Platelet (PLT)≥80 \* 10\^9 / L; (2) Liver and Renal function(without blood or albumin transfusion within 7 days before screening ): a. Alanine aminotransferase (ALT) and AST≤2.5 times the upper limit of normal value and ALT (AST≤5 times the upper limit of normal value when liver/bone metastasis) b. total bilirubin ≤1.5 times the upper limit of normal value; c.serum creatinine ≤1.5 times the upper limit of normal value, creatinine clearance≥60 ml/min; (3)Blood coagulation function: a.Activated partial thromboplastin time, international standardized ratio adn prothrombin time ≤1.5 times the upper limit of normal value; b.Doppler echocardiographic evaluation: left ventricular ejection fraction(LVEF)≥ 50%
•Subjects agreed to join the study and signed informed consent;

Exclusion Criteria

•Previously received anti angiogenic drugs including but not limited to small molecules such as anlotinib and apatinib and large molecules such as bevacizumab.
•Patients allergic to the any test drug.
•Combined disease/ history:
•Clinical significant hemoptysis occurred within 3 months before admission (daily hemoptysis was greater than 50ml), or significant clinical bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood or above, or suffering from vasculitis, etc;
•Arteriovenous thrombosis events occurred within 6 months before grouping, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except venous thrombosis caused by venous catheterization due to early chemotherapy) and pulmonary embolism;
•Hypertension, which can not be well controlled by antihypertensive drugs (systolic blood pressure\>140 mmHg or diastolic blood pressure\>90 mmHg); Myocardial infarction, severe / unstable angina pectoris, cardiac insufficiency above New York Heart Association(NYHA) , supraventricular or ventricular arrhythmias with clinical significance, and symptomatic congestive heart failure occurred within 6 months before grouping;
•Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (e.g. diabetes, pulmonary fibrosis and acute pneumonia);
•Renal insufficiency: urine routine indicates urinary protein ≥ + +, or confirms 24-hour urinary protein ≥ 1.0g;
•History of live attenuated vaccine vaccination within 28 days before the first study medication or expected live attenuated vaccination during the study period;
•Human immunodeficiency virus infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis;

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

Time Frame: Through study completion, an average of 1-2 year

Progression Free Survival (PFS) is defined as the time from the initial treatment to disease progression (defined by RECIST 1.1) or death of any cause