EUCTR2019-003659-13-IT进行中（未招募）1 期
A Phase 2 Multi-Center, Open Label Study to Assess the Safety,Efficacy and Pharmacodynamics of IMG-7289 in Patients with Essential Thrombocythemia - IMG-7289-CTP-201 Phase 2 Essential Thrombocythemia Study
适应症
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
- All
入选标准
- •Patients must meet all of the applicable criteria to be eligible for
- •enrollment in this study:
- •1. Age >= 18 years.
- •2. Diagnosis of Essential Thrombocythemia per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms (Arber et al., 2016).
- •3. Patients who have failed at least one standard therapy (failure is the equivalent of inadequate response or intolerance). European Leukemia Net (ELN) criteria for intolerance / resistance to hydroxyurea (Appendix
- •16.8) may be used in association with Investigator discretion. Ruxolitinib refractoriness or intolerance will be left to the discretion of the Investigator.
- •4. Requires treatment in order to lower platelet count based on patient age over 60 or history of thrombosis.
- •5. Platelet count > 450 k/µL (450 x 109/L) pre-dose Day 1.
- •6. Peripheral blast count < 1% pre-dose Day 1.
- •7. ANC >= 0.5 x 109/L pre-dose Day 1.
- •8. Fibrosis Score < grade 2, as per a slightly modified version (Arber et al., 2016) of the European Consensus Criteria for Grading Myelofibrosis, (Thiele et al., 2005).
- •9. Life expectancy > 36 weeks.
- •10. Able to swallow capsules.
- •11. Amenable to bone marrow evaluations and peripheral blood sampling during the study.
- •12. Must have discontinued ET therapy at least 1 week (4 weeks for interferon) prior to study drug initiation.
- •13. Women of childbearing potential (WOCBP) and fertile men (see Section 6.1.) must agree to use an approved method of contraception from Screening until 14 days* after last IMG-7289 dose. Methods of
- •contraception include: estrogen and progestogen combined hormonal contraception which inhibits ovulation; progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device
- •(IUD); bilateral tubal occlusion; vasectomized partner in a monogamous sexual relationship (vasectomy or tubal ligation at least six months prior to dosing); and, complete sexual abstinence (defined in Section 6.1).
- •Males with a pregnant partner must agree to use a condom to avoid exposure to the developing child. Patients practicing abstinence must agree to use an approved method of contraception should they become
- •sexually active during the study.
- •*The risk of embryofetal toxicity is fully mitigated by 28 days which is >10 half-lives of the drug at the doses used in this study.
- •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 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •Patients will be excluded from the study if they meet any of the
- •following criteria:
- •1. Hemoglobin < 10 g/dL prior to dosing on Day 1.
- •2. Transfusion dependency, defined as requiring 2 or more units of pack red blood cells per month for more than 3 months, or a hemoglobin level of <=8g/dL in the preceding 8 weeks before the start of dosing.
- •3. Eastern Cooperative Oncology Group (ECOG) questionnaire score of 3 or greater at Screening.
- •4. History of splenectomy.
- •5. Has undergone major surgery <=4 weeks prior to starting study drug or has not recovered from side effects of such surgery.
- •6. Unresolved treatment related toxicities from prior therapies (unless resolved to <= Grade 1).
- •7. Uncontrolled active infection.
- •8. Known positive for HIV if not well-controlled (i.e., undetectable viral load) or infectious hepatitis, type A, B or C.
- •9. Current use of monoamine oxidase A and B inhibitors (MAOIs).
- •10. Evidence at the time of screening of increased risk of bleeding, including any of the following:
- •Activated partial thromboplastin time (aPTT) > 1.3 x the upper limit of normal
- •International normalized ratio (INR) >1.3 x the local upper limit of normal
- •History of severe thrombocytopenia or platelet dysfunction unrelated to a myeloproliferative disorder or its treatment
- •Known bleeding disorder (e.g., dysfibrinogenaemia, factor IX deficiency, haemophilia, Von Willebrand's disorder, Disseminated Intravascular Coagulation [DIC], fibrinogen deficiency, or other clotting
- •factor deficiency).
- •11. Evidence at the time of Screening of significant renal or hepatic insufficiency (unless due to haemolysis, or leukaemic infiltration) as defined by any of the following local lab parameters:
- •Calculated glomerular filtration rate (GFR; using the Cockcroft-Gault equation) <40 mL/min or serum creatinine > 1.5 x the local upper limit of normal
- •Aspartate transaminase (AST) or alanine aminotransferase (ALT) >=2 x the local upper limit of normal
- •12. Current use of a prohibited medication (e.g., romiplostim) or expected to require any of these medications during treatment with the investigational drug.
- •13. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to IMG-7289 or LSD1 inhibitors (i.e., monoamine oxidase inhibitors; MAOIs) that contraindicates their
- •participation.
- •14. History of any illness/impairment of gastrointestinal (GI) function that might interfere with drug absorption (e.g., chronic diarrhea), confound the study results or pose an additional risk to the patient by
- •participation in the study; patients with gastric bypass surgery.
- •15. Use of an investigational agent within less than 14 days, or the equivalent of at least 7 half-lives of that agent, whichever is the longer, prior to the study Day 1.
- •16. Females who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study.
- •17. A concurrent second active and non-stable malignancy (patients with a concurrent second active but stable malignancy, such as non melanoma skin cancers, are eligible).
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