EUCTR2017-004012-19-NL进行中（未招募）1 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
Principia Biopharma, a Sanofi Company0 个研究点目标入组 83 人开始时间: 2019年2月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 83
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. 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 options with a platelet count of <30,000/µL on two occasions no less than 7 days apart in the 15 days prior to beginning study treatment.
- •4. A history of response (two or more platelet counts = 50,000/µL with an increase of at least 20,000/µL) to at least one prior line of therapy (with splenectomy being 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,
- •sexual abstinence when this is in line with the preferred and usual lifestyle of the patient). Unless surgically sterile, postmenopausal females should have menopause confirmed by FSH testing.
- •7. Able to provide written informed consent and agreeable to the schedule of assessments
- •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 other 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 hormonereleasing 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 should have
- •menopause confirmed by FSH testing.
- •7. Able to provide written informed consent and agreeable to the
- •schedule of assessments
- •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 67
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •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 rate above 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 before Day 1
- •5. Change in corticosteroid and/or TPO agonist dose within 2 weeks prior to Day 1 (more than 10% variation from Day 1 daily doses)
- •6. Use of rescue medications other than corticosteroids or TPO in Exclusion Criterion #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 drugs 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 within 3 days or 5 half-lives (whichever is longer) of study drug dosing including, but not 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 (NSAIDs), thienopyridenes (within 14 days of planned dosing through end of
- •follow-up).
- •13. Has received any investigational drug within the 30 days before receiving the first 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 the 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 for screening for HIV, hepatitis B (surface 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 3 months 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 the study
- •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
- •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 rate above 100 beats/min on ECG), or other clinically
- •significant abnormalities
- •3. History (within 5 years of SD1) or current, active malignancy requiring or likely to r
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