EUCTR2007-001506-25-DE进行中（未招募）不适用
An open–label Phase 2 Trial of Pegylated Liposomal Doxorubicin and rIL-21 in Ovarian Cancer Patients with Persistent or Progressive Disease after, or Relapse within One Year of, Completion of Standard First Line Therapy
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
- •2.Advanced epithelial OC (stage IIB-IV), histologically confirmed according to AJCC (3)
- •3.Persistent or progressive disease after or relapse within 1 year of completion of first line platinum-containing chemotherapy
- •4.At least 1 measurable lesion = 5 cm in the largest diameter according to RECIST criteria or assessable disease defined as: a one-dimensional measurable lesion, mass with margins not clearly defined, lesions with both diameters 0.5 cm or less on radiographic imaging, palpable lesions under 2 cm or malignant ascites respectively combined with a 2 x UNL (in the absence of cirrhosis) of CA-125 measured within 2 weeks prior to inclusion in the trial.
- •5.18 years of age or above
- •6.ECOG performance status = 2
- •7.Haematopoietic and renal:
- •a.White blood cell (WBC) = 2.5 x 10^9/L
- •b.Absolute neutrophil count (ANC) = 1.5 x 10^9/L
- •c.Platelet count = 100 x 10^9/L
- •d.Haemoglobin = 6.2 mmol/L
- •e.Lymphocytes = 0.8 x 10^9/L
- •f.No signs of haemolytic anaemia
- •g.Serum-creatinine = 177 µmol/L
- •a.Bilirubin = 1.2 x UNL
- •b.ALAT and ASAT/SGOT = 2.5 x UNL (if liver metastasis then = 4 x UNL)
- •c.LDH = 2 x UNL
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.More than one prior chemotherapy regimen
- •2.First-line chemotherapy within 1 month prior to enrolment
- •3.Radiotherapy less than 4 weeks prior to start of treatment for bone metastasis and less than 8 weeks for visceral metastasis
- •4.Previous mediastinal or left thoracic irradiation
- •5.Bulky disease defined as 1 or more lesions > 5 cm in the largest diameter according to RECIST criteria
- •6.Documented positive serologic testing for hepatitis B or C within a year prior to start of treatment
- •7.History of or active presence of auto-immune diseases (except vitiligo and treated pernicious anaemia)
- •8.History of any other active malignancy (except basal cell carcinoma of the skin and cervical cancer in situ) within 5 years prior to enrolment
- •9.Left ventricular ejection fraction < 0.50, determined by Multigated Acquisition (MUGA) or echocardiography
- •10.Cardiac disease within the last 12 months defined as:
- •a.Decompensate heart failure (New York Heart Association (NYHA) class III or IV
- •b.Unstable angina pectoris
- •c.Myocardial infarction
- •11.Signs of CNS metastasis: either known brain metastasis or symptoms of brain metastasis
- •12.Known chronic infectious disease including human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related illness
- •13.Any significant systemic disease which according to the investigator could compromise the safety of the subject or interfere with the trial objectives
- •14.Concurrent treatment with systemic corticosteroids (topical or inhaled corticosteroid treatment is permitted)
- •15.Known or suspected allergy to trial product or related products
- •16.Previous participation (treatment) in this trial
- •17.Concurrent participation in any other trial with experimental therapy
- •18.Pregnant or the intention of becoming pregnant or not using adequate contraceptive measures (Adequate contraception includes: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner)
研究者
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