EUCTR2010-018768-18-AT进行中（未招募）1 期
An open-label, prospective, multicentre, phase I/II dose escalation study to determine the maximum tolerated dose and to assess the safety and efficacy of P1101, PEG-Proline-Interferon alpha-2b for patients with Polycythaemia vera (PV).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 51
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
- All
入选标准
- •1. Written informed consent obtained prior to any study specific screening activities and able to comply with this protocol
- •2. Patients age =18 years
- •3. Confirmed diagnosis of PV according to either the WHO criteria 2008 or the PSVG criteria plus JAK-2 positivity.
- •4. Eastern Cooperative Oncology Group performance status = 2
- •5. If female of childbearing potential – have a negative urine pregnancy test result within 7 days prior to the scheduled first application of investigational product and agree to employ adequate birth control measures for the duration of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 37
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •1. Diagnosis of any other myeloproliferative disorder
- •2. Any clinically significant illness or surgery within 4 weeks prior to dosing
- •3. Systemic infections, e.g. hepatitis B, hepatitis C, or HIV at screening
- •4. Uncontrolled hypertension (systolic > 150 mmHg and diastolic > 100 mmHg, or clinically significant (i.e. active) cardiovascular disease: CVA/stroke (= 3 months prior to enrolment), myocardial infarction (= 3 months prior to enrolment), significant coronary artery stenosis, unstable angina, New York Heart Association (NYHA) Class 2 or greater Congestive heart failure, or serious cardiac arrhythmia requiring medication.
- •5. Previous treatment with Interferon for PV
- •6. Concurrent treatment with other cytoreductive agents other than Hydroxyurea and investigational agents of any type
- •7. History of malignant disease, including solid tumours and haematological malignancies (except basal cell and squamous cell carcinomas of the skin and carcinoma in situ of the cervix that have been completely excised and are considered cured) within the last 3 years
- •8. History of severe allergic (like anaphylaxis) or hypersensitivity reactions (like angioedema), any known or suspected intolerance to the investigational product.
- •9. Use of any investigational drug or participation in an investigational drug study within the last 4 weeks
- •10. Clinically significant history or known presence of psychiatric disorders, including but not limited to depression, anxiety and sleep disorders
- •11. Organ transplant, past or planned
- •12. Inadequate liver function:
- •Serum (total) bilirubin > 2,5 x ULN, AST and ALT > 2,5 x ULN
- •13. Clinically significant ECG findings
- •14. History of renal disease requiring haemodialysis or seizure disorder requiring anticonvulsant therapy
- •15. Pregnant or lactating females (pregnancy test to be assessed within 7 days prior to study treatment start)
- •16. Acute or chronic infections or autoimmune diseases (collagen diseases, polyarthritis, immune thrombocythemia, psoriasis, lupus etc, thyroiditis.)
研究者
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