EUCTR2018-003811-23-DE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
- 90
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) intermediate risk-2 (2 prognostic factors) or intermediate risk-1 (1 prognostic factor). 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 and, in the US, fedratinib).
- •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 k/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
- •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 th
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
- •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).
- •For Italy ONLY, Exclusion 13 reads: Active infection with hepatitis B
- •virus (positive hepatitis B surface antigen; note: positive hepatitis B
- •surface antibody and positive hepatitis B core antibody are not
- •exclusionary provided disease is not active, which should be clearly
- •documented in the patient's medical history) or C virus (patients with
- •positive hepatitis C antibody result would require confirmation of active
- •disease with a positive hepatitis C polymerase chain reaction (PCR)
- •test), seropositivity for human immunodeficiency virus HIV).
- •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 t
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