Anlotinib Combined With Carboplatin/Paclitaxel as First-line Treatment in Patients With Advanced Ovarian Cancer

NCT04807166 | Active Not Recruiting Phase 2

• 1 other identifier: JiangsuCHENG001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 6

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.

Conditions

Ovarian 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

Keywords

First-line treatment; Advanced Ovarian Cancer; Anlotinib; Carboplatin/Paclitaxel; Efficacy and Safety

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  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

  Through study completion, an average of 1-2 year

Secondary Outcomes (4)

• Overall Response Rate (ORR)

  Through study completion, an average of 1 year

• Disease Control Rate (DCR)

  Through study completion, an average of 1 year

• Overall survival (OS)

  Through study completion, an average of 1 year

• Adverse events (AE)

  Through study completion, an average of 1 year

Study Arms (1)

Anlotinib Combined With Carboplatin/Paclitaxel

EXPERIMENTAL

Anlotinib Combined With Carboplatin/Paclitaxel

Drug: Drug: Anlotinib; Drug: Drug: Carboplatin/Paclitaxel

Interventions

Drug: Anlotinib DRUG

Anlotinib will be administered orally,once a day (12 mg) on days 1-14 of a 21-day cycle

Also known as: FOCUS V

Anlotinib Combined With Carboplatin/Paclitaxel

Drug: Carboplatin/Paclitaxel DRUG

Paclitaxel 175 mg/m2 was given intravenously for 3 hours, D1 Carboplatin AUC 5 was given intravenously for 1 hour, D1

Also known as: bobei， Lipusu

Anlotinib Combined With Carboplatin/Paclitaxel

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• \. 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;
• There were severe infections within 4 weeks before the first administration, including, but not limited to, bacteremia and severe pneumonia requiring hospitalization; active infections requiring systemic antibiotics treatment of grade CTCAE ≥ 2 within 2 weeks before the first administration, or unexplained fever \> 38.5 °C during the screening period / before the first administration (the researchers judged that fever caused by tumors could be included in the group); there was evidence of active tuberculosis infection within 1 year before administration;
• Any other malignant tumor has been diagnosed within 3 years before enrollment, except for fully treated basal cell carcinoma or squamous cell skin cancer or cervical carcinoma in situ;
• Major surgery was performed within 28 days before enrollment (tissue biopsy required for diagnosis and central venous catheterization via peripheral venipuncture are allowed);
• Subjects who have previously received or are prepared to receive allogeneic bone marrow transplantation or solid organ transplantation;
• Patients with peripheral neuropathy ≥2 grade 2; patients with active brain metastasis, carcinomatous meningitis, spinal cord compression, or diseases found in brain or leptomeninges by imaging CT or MRI examination during screening (patients with brain metastasis who had completed treatment 14 days before admission and whose symptoms were stable can be enrolled in the group, but no symptoms of cerebral hemorrhage should be confirmed by cranial MRI, CT or venography)；

Sponsors & Collaborators

• Wenjun Cheng: lead

Study Sites (6)

Huai'an First People's Hospital

Huai'an, China

Location

Nanjing Drum Tower Hospital

Nanjing, China

Location

Zhongda Hospital Southeast University

Nanjing, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, China

Location

Affiliated Hospital of Jiangnan University

Wuxi, China

Location

Yancheng No.1 People's Hospital

Yancheng, China

Location

MeSH Terms

Conditions

Ovarian 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

Interventions

anlotinib; CP protocol

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms; Adnexal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urogenital Neoplasms; Genital Diseases; Gonadal Disorders; Fallopian Tube Diseases

Study Officials

• Wenjun Cheng, MD,PhD

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Head of Gynecology

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 19, 2021
• Study Start: August 24, 2021
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)