EUCTR2018-003811-23-GB进行中（未招募）1 期
A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 in Patients with Myelofibrosis. - IMG-7289-CTP-102 Phase 2b expansion
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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.Willing and able to sign the approved informed consent.
- •2.Age: 18+ years old at Screening.
- •3.Diagnosis of either PMF per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms (Section 16.2), PPV-MF per the IWG-MRT (Section 16.3), or PET-MF per the IWG-MRT (Section 16.4) and meet the following additional subtype specific criteria:
- •a.Classified as high risk (3 prognostic factors) OR intermediate risk-2 (2 prognostic factors). The prognostic factors, defined by the International Working Group (Cervantes, et al., 2009):
- •i.Age > 65 years;
- •ii.Presence of constitutional symptoms (weight loss, fever, night sweats);
- •iii.Marked anaemia (Hgb < 10g/dL)*;
- •iv.History of leukocytosis [WBC > 25 x109/L (25,000/µL)];
- •v.Circulating blasts = 1%.
- •*A haemoglobin value < 10 g/dL must be demonstrated during Screening for patients who are not transfusion dependent. Patients receiving regular transfusions of packed red blood cells will be considered to have haemoglobin < 10 g/dL for the purpose of evaluation of risk factors.
- •4.Be refractory or resistant to, inadequately controlled by or intolerant of available approved therapy, or in the Investigator’s judgment, are not candidates for available approved therapy (note: approved therapy includes ruxolitinib).
- •5.Eastern Cooperative Oncology Group (ECOG) performance status score =2.
- •6.Peripheral blast count =10% prior to dosing on Day 0.
- •7.Absolute neutrophil count = 0.5 x 109/L (500/µL) prior to dosing on Day 0
- •8.Platelet count = 100 x 109/L (100,000/µL) prior to dosing on Day 0.
- •9.Life expectancy >36 weeks.
- •10.Have discontinued all previous therapies for MPNs including ruxolitinib, any chemotherapeutic agents, immunosuppressive therapy (e.g., corticosteroids > 10 mg/day with the noted exception: use of corticosteroids for management of gout is allowed; maintenance supplemental corticosteroid therapy such as prednisone = 10 mg/day or corticosteroid equivalent is allowed), immune modulators (e.g., thalidomide), radiotherapy for at least 2 weeks prior, and interferon for 4 weeks prior to study Day 0. Low dose acetylsalicyclic acid is permitted. Palliative radiation treatment to non-index or bone lesions performed < 2 weeks before treatment may be considered with Medical Monitor approval.
- •11.Amenable to bone marrow evaluation, peripheral blood and urine sampling during the study.
- •12.Able to swallow capsules.
- •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 28 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 as refraining from heterosexual intercourse). Patients practicing abstinence must agree to use an approved method of contraception should they become sexually active during the study.
- •Note: In the UK, males with a pregnant partner must agree to use a condom to avoid exposure to the developing child.
- •*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 unde
排除标准
- •1.Has undergone major surgery =4 weeks prior to starting study drug or has not recovered from side effects of such surgery.
- •2.Has undergone any surgical procedure within 2 weeks, excluding minor procedures (e.g., skin biopsy or central venous catheter placement/removal) prior to starting study drug.
- •3.History of splenectomy.
- •4.History of or scheduled haematopoietic stem-cell transplant within 24 weeks of screening.
- •5.Unresolved treatment related toxicities from prior therapies (unless resolved to = Grade 1).
- •6.Current use of a prohibited medication (e.g., romiplostim) or expected to require any of these medications during treatment with the investigational drug.
- •7.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.
- •8.Current use of monoamine oxidase A and B inhibitors (MAOIs).
- •9.Uncontrolled active infection.
- •10.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).
- •11.Evidence at the time of Screening of risk of bleeding, including any of the following:
- •a.Activated partial thromboplastin time (aPTT) = 1.3 x the local upper limit of normal
- •b.International normalized ratio (INR) = 1.3 x the local upper limit of normal
- •c.History of severe thrombocytopenia or platelet dysfunction unrelated to a myeloproliferative disorder or its treatment
- •d.Known bleeding disorder (e.g., dysfibrinogenaemia, factor IX deficiency, haemophilia, Von Willebrand's disease, Disseminated Intravascular Coagulation [DIC], fibrinogen deficiency, or other clotting factor deficiency)
- •12.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:
- •a.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
- •b.Aspartate transaminase (AST) or alanine aminotransferase (ALT) =2 x the local upper limit of normal
- •13.Known human immunodeficiency virus (HIV) infection or known active Hepatitis B or Hepatitis C virus infection (testing will not be conducted as part of Screening procedures).
- •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 study Day 0.
- •16.Pregnant or lactating females; females intending to become pregnant within 6 months; females intending to become pregnant at any time during the study
研究者
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