Open Label Randomized Clinical Study of Plasmid Encoding p62/SQSTM1 (ELenagen) in in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Phase II, two arm prospective study of efficacy and safety of ELENAGEN in combination with gemcitabine in comparison with gemcitabine alone in patients with platinum-resistant ovarian cancer.
详细描述
The purpose of this clinical study is to evaluate safety and efficacy of ELENAGEN, a novel anticancer therapeutics (plasmid DNA encoding p62/SQSTM1) protein, as an adjuvant to chemotherapy with Gemcitabin (GEM) in patients with advanced platinum-resistant ovarian cancer.
This is a prospective randomized multi-center study with two arms. Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks) is administered in both arms: In the Chemo arm (n = 20) Gemcitabine is the only treatment, and in the ELENAGEN arm (n = 20) GEM was supplemented with ELENAGEN (2.5 mg i.m. weekly). The primary endpoint is progression-free survival (PFS), and the secondary endpoint is safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient is 18-70 years old.
- •Written informed consent of the patient to participate in clinical trials.
- •Presence of histologically confirmed ovarian cancer.
- •The return of the disease occurred less than 6 months after the last administration of platinum.
- •Presence of measurable tumor lesions according to RECIST 1.1 criteria.
- •Functional status according to ECOG scale is 0-
- •Life expectancy of at least 6 months.
- •Adequate function of the organs as determined by the following criteria:
- •Absolute number of neutrophils (ANN) ≥1500/mm3 (≥1.5 × 109/l);
- •Platelet count ≥100,000/mm3 (IU: ≥100 × 109/l).
- •Hemoglobin level ≥ 9.0 g/dL determined by analysis performed at least 2 weeks after the last hemotransfusion;
- •The level of AST and ALT in blood serum not exceeding more than 3 times the upper limit of the norm.
- •The level of serum bilirubin not exceeding more than 1.5 times the upper limit of normal.
- •Serum Creatinine ≤ 1.5 mg/dL.
- •The ability of the patient to follow the directions of the research physician and follow the study regimen.
排除标准
- •Criteria by which patients are not included in the study
- •Platinum-sensitive relapse of ovarian cancer (disease recurrence occurred more than 6 months after the last administration of platinum drugs).
- •Presence of serious diseases or health conditions:
- •Other malignancies, with the exception of malignancies treated more than 5 years ago without signs of return of the disease.
- •Brain metastases or leptomeningeal metastases.
- •Active infection (e.g. fever ≥38 °C), including active or unresolved pneumonia/pneumonitis.
- •Uncontrolled diabetes mellitus.
- •Myocardial Infarction in the last 12 months, severe/unstable angina, clinically manifested heart failure class III-IV according to the classification of the New York Cardiology Association (NYCA).
- •Gastrointestinal bleeding within the last 2 weeks.
- •Human immunodeficiency virus (HIV), chronic or acute hepatitis B or hepatitis C.
- •Patients with autoimmune disorders or organ transplantation who require immunosuppressive therapy.
- •I. Mental illness that may increase the risk associated with participation in the study or taking the study drug or that may affect the interpretation of the results of the study.
- •K. Polyallergy, bronchial asthma (including aspirin) in history.
- •Major surgery during the previous 4 weeks (complete wound healing).
- •Previous chemotherapeutic treatment of the patient according to the scheme GEMCITABINE
- •Radiotherapy with extended field radiation within the previous 4 weeks or radiotherapy with a limited field radiation within the previous 2 weeks.
研究组 & 干预措施
Gemcitabin
Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks
干预措施: Gemcitabine (Drug)
Gemcitabine+Elenagen
GEM was supplemented with ELENAGEN (2.5 mg i.m. weekly)
干预措施: Gemcitabine (Drug)
Gemcitabine+Elenagen
GEM was supplemented with ELENAGEN (2.5 mg i.m. weekly)
干预措施: ELENAGEN (Biological)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 2 years since the start of treatment
Median duration of time from start of treatment to time of progression by RESIST 1.1 criterion or death
Progression-free Survival (PFS)
时间窗: 2 years since the start of treatment
Median duration of time from start of treatment to time of progression by RESIST 1.1 criterion or death. Progression is defined using RECIST v 1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Safety of Elenagen in combination with Gemcitabine(1 year after the start of treatment)
- Safety of Elenagen in Combination With Gemcitabine(1 year after the start of treatment)