NL-OMON52638招募中2 期
An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of Rilzabrutinib (PRN1008), an Oral BTK Inhibitor, in Patients with Relapsed Immune Thrombocytopenia - PRN1008-010
Principia Biopharma, a Sanofi Company0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion Criteria:
- •1. Male or female patients, aged 18 to 80 years old (Czech Republic and Norway
- •only: 18 to 65 years old)
- •2. Immune-related ITP (both primary and secondary)
- •3. Refractory or relapsed patients with no available and approved therapeutic
- •with a platelet count of <30,000/µL on two occasions no less than 7 days apart
- •the 15 days prior to beginning study treatment.
- •4. A history of response (two or more platelet counts >=50,000/µL with an
- •of at least 20,000/µL) to at least one prior line of therapy (with splenectomy
- •considered a line of therapy)
- •5. Adequate hematologic, hepatic, and renal function (absolute neutrophil count
- •>=1.5 × 109/L, hemoglobin [Hgb] >9 g/dL, AST/ALT <=1.5 × ULN, albumin
- •>=3 g/dL, total bilirubin <=1.5 × ULN, estimated glomerular filtration rate [eGFR]
- •> 60 mL/min (Cockcroft and Gault method) (C1D1 pre-dose may be checked up to
- •Day -3 prior to C1D1)
- •6. Female patients who are of reproductive potential must agree for the
- •duration of
- •active treatment in the study to use a highly effective means of contraception
- •(hormonal contraception methods that inhibits ovulation, intrauterine device,
- •intrauterine hormone-releasing system, bilateral tubal ligation, vasectomized
- •partner, or true abstinence; when this is in line with the preferred and usual
- •lifestyle of the patient). Unless surgically sterile, postmenopausal females
- •have menopause confirmed by follicle-stimulating hormone (FSH) testing.
- •7. Able to provide written informed consent and agreeable to the schedule of
- •assessments
- •Inclusion Criteria:
- •1. Male or female patients, aged 18 to 80 years old
- •2. Patients with immune-related ITP (both primary and secondary) as defined by
- •current guidelines with at least 3 months duration
- •3. Patients who had a response (achievement of platelet count >=50,000/µL) to
- •IVIg/anti-D or corticosteroid that was not sustained and failed at least one
- •ITP therapy (that was not IVIg or corticosteroid 4. Patients with a platelet
- •count of <30,000/µL on two occasions no less than 7 days
- •apart in the 15 days before treatment begins, and no platelet count above
- •35,000/µL on Study Day 1.
- •5. Patients with adequate hematologic, hepatic, and renal function (absolute
- •neutrophil count >=1.5 × 109/L, Hgb >9 g/dL, AST/ALT <=1.5 × ULN, albumin
- •>=3 g/dL, total bilirubin <=1.5 × ULN, eGFR >50 mL/min (Cockcroft and Gault
- •method) (pre-dose may be checked up to Day -3)
- •6. Female patients who are of reproductive potential must agree for the duration
- •of active treatment in the study to use a highly effective means of
- •contraception
- •(hormonal contraception methods that inhibits ovulation, intrauterine device,
- •intrauterine hormone-releasing system, bilateral tubal ligation, vasectomized
- •partner, or true abstinence; when this is in line with the preferred and usual
- •lifestyle of the patient). Unless surgically sterile, postmenopausal females
- •have menopause confirmed by FSH testing.
- •7. Able to provide written informed consent and agreeable to the schedule of
- •assessments
排除标准
- •Exclusion Criteria:
- •1. Pregnant or lactating women
- •2. ECG findings of QTcF >450 msec (males) or >470 msec (females), poorly
- •controlled atrial fibrillation (i.e., symptomatic patients or a ventricular
- •100 beats/min on ECG), or other clinically significant abnormalities 3. History
- •of current, active malignancy requiring or likely to require
- •chemotherapeutic or surgical treatment during the trial, with the exception
- •of non-melanoma skin cancer
- •4. Transfusion with blood or blood products or plasmapheresis within 2 weeks
- •5. Change in corticosteroid and/or TPO agonist dose within 2 weeks prior to Day
- •(more than 10% variation from Day 1 daily doses)
- •6. Use of rescue medications other than corticosteroids or TPO in Exclusion
- •#5 in the two weeks before Day 1
- •7. Immunosuppressant drugs other than corticosteroids - these drugs should be
- •discontinued for at least 14 days before Day 1
- •8. Treatment with rituximab or splenectomy within the 3 months prior to Day 1
- •9. Ongoing need for the use of proton pump inhibitor drugs such as omeprazole
- •and esomeprazole (it is acceptable to change patient to H2 receptor blocking
- •prior to Day 1)
- •10. Concomitant use of known strong-to-moderate inducers or inhibitors of CYP3A
- •within 3 days or 5 half-lives (whichever is longer) of Day 1
- •11. Use of CYP3A-sensitive substrate drugs with a narrow therapeutic index
- •3 days or 5 half-lives (whichever is longer) of study drug dosing including,
- •limited to, alfentanil, astemizole, cisapride, cyclosporine, dihydroergotamine,
- •ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, or terfenadine
- •12. Planned or concomitant use of any anticoagulants and platelet aggregation
- •inhibiting drugs such as aspirin, non-steroidal anti-inflammatory drugs
- •thienopyridenes (within 14 days of planned dosing through end of follow-up)
- •13. Has received any investigational drug within the 30 days before receiving
- •dose of study medication, or at least 5 times elimination half-life of the drug
- •(whichever is longer); patient should not be using an investigational device at
- •time of dosing
- •14. Current drug or alcohol abuse
- •15. Refractory nausea and vomiting, malabsorption, external biliary shunt, or
- •significant bowel resection that would preclude adequate study drug absorption
- •16. History of solid organ transplant
- •17. Positive screening for human immunodeficiency virus (HIV), hepatitis B
- •antigen and core antibodies unrelated to vaccination), or hepatitis C (anti-HCV
- •antibody confirmed with HCV RNA)
- •18. History of serious infections requiring intravenous therapy within the last
- •before Day 1
- •19. Clinically significant cognitive dysfunction (>= Grade 1) or medical history
- •suggestive of increased risk for cognitive dysfunction during the study
- •20. Live vaccine within 28 days prior to Day 1 or plan to receive one during
- •21. Planned surgery in the time frame of the dosing period
- •22. Any other clinically significant disease, condition, or medical history
- •that, in the
- •opinion of the Investigator, would interfere with patient safety, study
- •evaluations,
- •and/or study procedures
- 另有 2 项未显示
研究者
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