EUCTR2010-024473-39-HU进行中（未招募）1 期
An open-label, multicenter, expanded access study of INC424 for patients with primary myelofibrosis (PMF) of post polycythemia vera myelofibrosis (PPV MF) or post-essential thrombocythemia myelofibrosis (PET-MF)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,500
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. Patients must give written informed consent according to local guidelines prior to any screening procedures.
- •2. Patients must not be eligible for another ongoing INC424 clinical trial.
- •3. Male or female patients aged = 18 years of age.
- •4. Patients must be diagnosed with PMF, PPV-MF or PET-MF, according to the 2008 revised International Standard Criteria , irrespective of JAK2 mutation status.
- •5. Patients with PMF requiring therapy must be classified as high risk (3 prognostic factors) OR intermediate risk level 2 (2 prognostic factors, no more), OR intermediate risk level 1 with an enlarged spleen at the screening visit (assessment to occur at the Screening Visit). The prognostic factors, defined by the International Working Group (Cervantes 2009) are described in Section 1.1 and Section 5.2 and should be evaluated at the Screening Visit.
- •6. Patients with Intermediate-1 and splenomegaly, must have a palpable spleen measuring 5 cm or greater from the costal margin to the point of greatest splenic protrusion.
- •7. Patients with a peripheral blood blast percentage count of < 10%.
- •8. Patients with adequate liver function defined as total bilirubin or direct bilirubin = 2.0 x ULN, and ALT = 2.5 x ULN.
- •9. Patients with adequate renal function defined as serum creatinine
- •= 2 x ULN.
- •10. Patients with an ECOG performance status of 0, 1, or 2
- •11. Women of childbearing potential must have had a negative serum pregnancy test within 14 days prior to the administration of study drug.
- •12. Patients must have recovered or stabilized sufficiently from any adverse drug reactions associated with prior treatments before beginning treatment with INC424.
- •13. Fedratinib pretreated patients with documented complete physical examination including full neurologic examination and cardiology assessment, thiamine level testing, and MRI of the brain if indicated based on signs or symptoms. Patients pretreated with fedratinib should have completed or be receiving thiamine supplementation according to the investigator’s instructions.
- •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. Patients eligible for hematopoietic stem cell transplantation (suitable candidate and a suitable donor is available).
- •2. Patients with a history of malignancy in the past 3 years, except for treated early stage squamous or basal cell carcinoma in situ.
- •3. Patients receiving any medications listed in the Prohibited Medications” listing
- •4. Impairment of GI function or GI disease that may significantly alter the absorption of INC424
- •5. Patients with cardiac disease which in the Investigator’s opinion may jeopardize the safety of the patient or the compliance with the protocol.
- •6. Patients with currently uncontrolled or unstable angina, rapid or paroxysmal fibrillation or recent (approximately 6 months) myocardial infarction or acute coronary syndrome.
- •7. Patients with clinically significant bacterial, fungal, parasitic or viral infection that requires therapy. Patients with acute bacterial infections requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed.
- •8. Patients with known active hepatitis A, B, C or who are HIV-positive.
- •9. Patients with inadequate bone marrow reserve at baseline visit as demonstrated by:
- •(a) ANC that is = 1000/µL.
- •(b) Platelet count that is <50,000/µL without the assistance of growth factors, thrombopoietic factors or platelet transfusions.
- •10. Patients with any history of platelet counts < 50,000/µL or ANC <500/µL except during treatment for a MPD or treatment with cytotoxic therapy for any other reason.
- •11. Patients with coagulation parameters (PT, PTT, INR) >1.5 x ULN.
- •12. Patients with known hypersensitivity to INC424 or other JAK1/JAK2 inhibitors, or to its excipients.
- •13. Patients receiving ongoing treatment with another investigational medication or having been treated with an investigational medication within 30 days of screening or with fedratinib within 14 days of screeing.
- •14. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until termination of gestation, confirmed by a positive ßHCG laboratory test (> 5 mIU/mL).
- •15. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study duration inclusive of 28 days safety follow-up
- •16. Patients who are unable to comprehend or are unwilling to sign an ICF.
- •17. Patients with active alcohol or drug addiction that would interfere with their ability to comply with the study requirements.
- •18. Patients with any concurrent condition that, in the Investigator’s opinion, would jeopardize the safety of the patient or compliance with the protocol.
- •19. In the case of ruxolitinib pretreated patients, ruxolitinib primary resistant patients defined as:
- •No spleen reduction within the first 12 weeks after front line therapy with ruxolitinib. AND
- •No reduction in symptoms within the first 12 weeks after first-line treatment with ruxolitinib
- •20. In the case of ruxolitinib pretreated patients, patients discontinuing ruxolitinib due to a Grade 4 AE related or suspected to be related to ruxolitinib
研究者
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