EUCTR2015-003492-29-HU进行中（未招募）1 期
A Phase 1/2a, Open-Label, Parallel, Two-Arm, Dose-EscalationStudy to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of BAX69 in Subjects with Refractory Ovarian Cancer with Malignant Ascites - Phase 1/2a Two-Arm, Dose-Escalation of BAX69 in subjects with Malignant Ascites of Ovarian Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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. Provision of a signed informed consent
- •2. Female subjects of non-childbearing potential, 18 years of age and older at the
- •time of screening
- •3. Anticipated life expectancy >3 months at the time of screening
- •4. Metastatic ovarian epithelial cancer that is platinum resistant, and has no better
- •option available in the investigator’s opinion
- •5. Recurrent symptomatic malignant ascites having required 2 paracentesis within a 30-day interval prior to screening
- •6. ECOG PS of 0 to 2
- •7. Adequate hematological function, defined as:
- •Platelet count =100,000/µL
- •Prothrombin time (PT) and activated partial thromboplastin time (aPTT)
- •<1.5 times the upper limit of normal (ULN)
- •Absolute neutrophil count =1,000/µL
- •Hemoglobin =9 g/dL, without the need for transfusion in the 2 weeks prior to
- •8. Adequate renal function, defined as serum creatinine =2.0 times ULN and
- •creatinine clearance >50 mL/min or eGFR >50 mL/min/1.73 m2
- •9. Adequate liver function, defined as:
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
- •=2.5 times ULN for subjects without liver metastases, or =5 times ULN in the
- •presence of liver metastases
- •Bilirubin =2.0 times ULN, unless subject has known Gilbert’s syndrome
- •10. Adequate venous access
- •11. Subject is willing and able to comply with the requirements of the protocol
- •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 21
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 39
排除标准
- •1. Known central nervous system metastases
- •2. Prior malignancy within the past 3 years, with the exception of curatively treated
- •basal or squamous cell carcinoma of the skin, ductal carcinoma in situ of breast,
- •in situ cervical carcinoma, and superficial bladder cancer
- •3. Subjects who have an indwelling draining intraperitoneal catheter
- •4. Residual AEs >Grade 2 from previous treatment
- •5. Myocardial infarction within 6 months prior to C1D1, and/or prior diagnoses of
- •congestive heart failure (New York Heart Association Class III or IV), unstable
- •angina, unstable cardiac arrhythmia requiring medication; and/or the subject is at
- •risk for polymorphic ventricular tachycardia (eg, hypokalemia, family history or
- •long QT syndrome)
- •6. Uncontrolled hypertension defined as systolic blood pressure =160 mmHg and/or
- •diastolic blood pressure =100 mmHg confirmed upon repeated measures
- •7. Left ventricular ejection fraction <40% as determined by echocardiogram
- •(ECHO) performed at screening or within 90 days prior to C1D1
- •8. QT/QTc interval >450 msec, before C1D1 treatment administration, as
- •determined by screening ECG
- •9. Received anti-tumor therapy (chemotherapy, radiotherapy, retinoid therapy, or
- •hormonal therapy) within 4 weeks (less than 28 days) prior to C1D1; antibody
- •therapy, molecular targeted therapy within 5 half-lives prior to C1D1.
- •10. Major surgery within 4 weeks (less than 28 days) prior to C1D1
- •11. Active joint inflammation or other immune disorder involving joints
- •(osteoarthritis is not exclusionary)
- •12. Active infection involving IV antibiotics within 2 weeks prior to C1D1
- •13. Positive serology test for hepatitis B virus (HBV), hepatitis C virus (HCV), or
- •active tuberculosis
- •14. Positive serology test for human immunodeficiency virus (HIV) type 1 and 2, or
- •known history of other immunodeficiency disease
- •15. Albumin <3g/dL or total protein <6g/dL (it is not exclusionary if the patient receives albumin prophylactically)
- •16. Subject has received a live vaccine within 2 weeks (less than 14 days) prior to
- •17. Known hypersensitivity to any component of recombinant protein production by
- •Chinese Hamster Ovary cells.
- •18. Exposure to an investigational product or investigational device in another
- •clinical study within 4 weeks (less than 28 days) prior to screening, or is
- •scheduled to participate in another clinical study involving an investigational
- •product or device during the course of this study
- •19. Any disorder or disease, or clinically significant abnormality on laboratory or
- •other clinical test(s) (eg, blood tests and ECG), that in medical judgment of the
- •investigator may impede the subject’s participation in the study, pose increased
- •risk to the subject, and/or confound the results of the study
- •20. Subject is a family member or employee of the investigator.
研究者
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