Status:
UNKNOWN
Efficacy and Safety of Apatinib As Third Line Therapy in Patients With Advanced Ovarian Cancer
Lead Sponsor:
Sichuan Cancer Hospital and Research Institute
Conditions:
Angiogenesis Inhibitors，Ovarian Neoplasms
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
The study is to investigate the efficacy and safety of apatinib in patients with advanced ovarian cancer,who has received second-line chemotherapy and failed.
Detailed Description
Ovarian cancer is the third most common gynecological malignancy，just less than endometrial cancer and cervical cancer. Because most patients with advanced ovarian cancer can not get the ideal tumor c...
Eligibility Criteria
Inclusion
- 18 years to 70 years;
- Had a histologically or cytologically confirmed diagnosis of epithelial ovarian cancer；
- unfit for radical surgery and had received second-line chemotherapy，the disease still progressed or can not tolerate the chemotherapy;
- Had a disease status that was measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version1.1);
- Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2;
- Had a life expectancy of at least 12 weeks;
- Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥90g/L, platelets ≥ 80×10\^9/L, neutrophils ≥ 1.5×10\^9/L, total bilirubin within 1.5×the upper limit of normal (ULN), and b) ALT and AST≤2.5×the ULN (If liver metastases, serum creatine ≤ 1.5 x ULN);
- Had not gastrointestinal diseases that lead to malabsorption or impact Drug absorption;
- had good compliance;
- Signed and dated informed consent.
Exclusion
- patients who had received anti-vascular therapy;
- Allergic to any ingredients of Apatinib;
- Participated in other drug clinical researchers within four weeks;
- Have a variety of factors that affect oral medication (such as can not swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.)
- Severe infection;
- Patients with serious cardiovascular diseases,such as unstable angina, grade 3-4 heart dysfunction (NYHA Standard), congestive heart failure, poor-controlled arterial hypertension despite standard medical management;
- Patients who received major surgical operations within 4 weeks before screening;
- Patients who manifested arterial/venous thrombus events, e.g.cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening;
- Past or concurrent with other malignancies, except for cured skin basal cell carcinoma and cervical in situ cancer;
- Have a history of psychiatric abuse and can not quit or have mental disorders.
Key Trial Info
Start Date :
August 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03262545
Start Date
August 27 2017
End Date
February 1 2021
Last Update
August 28 2017
Active Locations (1)
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1
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 600000