EUCTR2019-000583-18-IT进行中（未招募）1 期
A Randomized, Double-Blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic, Anemic Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera (PV) Myelofibrosis, or Post Essential Thrombocythemia (ET) Myelofibrosis who were Previously Treated with JAK Inhibitor Therapy - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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. Age = 18 years
- •2. Confirmed diagnosis of PMF in accordance with the World Health Organization (WHO) 2016 criteria, or Post-PV/ET MF in accordance with the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria
- •3. Symptomatic, defined as a MFSAF TSS of = 10 units assessed by a single MFSAF v4.0 assessment during Screening prior to Day BL1
- •4. Anemic, defined as any of the following:
- •- For any subject; having received a transfusion within 28 days prior to the first day of Baseline assessments (BL1), with pre-transfusion Hgb < 10 g/dL, (if a subject receives a transfusion after Day BL1, but prior to Randomization, this pre-transfusion hemoglobin will be used foreligibility) or
- •- For subjects without ongoing JAK inhibitor therapy at Screening; Hgb < 10 g/dL during the Baseline Period (Days BL1 to Day BL7), or
- •- For subjects receiving ongoing JAK inhibitor therapy at Screening; Hgb < 10 g/dL during Screening, prior to the last day of Baseline assessments (Day BL7)
- •5. Previously treated, with an approved JAK inhibitor for PMF or Post-PV/ET MF for > = 90 days, or > = 28 days if JAK inhibitor therapy is complicated by RBC transfusion requirement of = 4 units in 8 weeks, or Grade 3/4 AEs of thrombocytopenia, anemia, or hematoma
- •- Subjects who discontinued JAK inhibitor therapy prior to Screening require no additional non-treatment interval
- •- For subjects with ongoing JAK inhibitor therapy at Screening, JAK inhibitor therapy must be tapered over a period of at least 1 week. Subjects receiving a low dose of JAK inhibitor, eg, 5 mg QD of RUX, may have a reduced taper period, or no taper, with the sponsor's approval. A non-treatment interval begin >=7 days prior to Day BL1 (the first of 7 consecutive days of baseline MFSAF assessments)
- •6. Baseline splenomegaly, defined as having a palpable spleen at = 5 cm, below the LCM, or with volume = 450 cm3 on imaging (ultrasound, MRI or CT are acceptable), assessed during Screening at any point prior to Randomization
- •7. High risk, intermediate-2, or intermediate-1 risk as defined by DIPSS, or DIPSS-plus
- •8. No allogeneic stem cell transplant planned
- •9. Acceptable laboratory assessments:
- •- ANC = 0.75 x 10(9)/L
- •- PLT = 25 x 10(9)/L (without requirement for platelet transfusion)
- •- Peripheral blast count < 10%
- •- AST/SGOT and ALT/SGPT = 3 x ULN
- •- Calculated creatinine clearance = 30 mL/min
- •- Direct bilirubin = 2.0 x ULN
- •10. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •11. Life expectancy > 24 weeks
- •12. Able to understand and willing to sign the ICF
- •13. Willing and able to complete PRO assessments using an ePRO device according to protocol
- •14. WOCBP, men with partners of childbearing potential, and subjects with pregnant or lactating partners must agree to follow the contraceptive requirements of the clinical trial protocol, effective from the first administration of MMB, throughout the trial and for 6 months after the last dose of MMB.
- •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 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 144
排除标准
- •1. Use of the following treatments within the time periods noted (criteria a-i), restricted therapies are further described in protocol section 5.3.3.
- •2. History of prostate cancer, with the exception of localized prostate cancer that has been treated surgically or by radiotherapy with curative intent and presumed cured
- •3. Prostate specific antigen (PSA) > 4 ng/mL
- •4. Unsuitable for spleen volume measurements due to prior splenectomy or unwilling or unable to undergo an MRI or CT scan for spleen volume measurement per protocol requirements in Section 8.3
- •5. Any of the following (criteria a-k):
- •a. Uncontrolled intercurrent illness including, but not limited to: active uncontrolled infection (subjects receiving outpatient antibacterial and/or antiviral treatments for infection that is under control or as infection prophylaxis may be included in the trial)
- •b. Significant active or chronic bleeding event = Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, within 4 weeks prior to Randomization
- •c. Unstable angina pectoris within 6 months prior to Randomization
- •d. Symptomatic congestive heart failure within 6 months prior to Randomization
- •e. Uncontrolled cardiac arrhythmia within 6 months prior to Randomization
- •f. QTcF interval > 500 msec, unless attributed to bundle branch block
- •g. Current progressive thrombosis despite treatment
- •h. History of porphyria
- •i. Child-Pugh score = 10
- •j. Psychiatric illness, social situation, or any other condition that would limit compliance with trial requirements or may interfere with the interpretation of study results, as judged by investigator or sponsor
- •k. Inability or unwillingness to comply with the protocol restrictions on MF therapy and other medications prior to and during study treatment
- •6. Subjects with a prior or concurrent malignancy, whose natural history or treatment has a significant potential to interfere with the safety or efficacy assessment of the investigational regimen
- •7. Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding or thalassemia
- •8. Known positive status for HIV
- •9. Chronic active or acute viral hepatitis A, B, or C infection, or hepatitis B or C carrier (testing required for hepatitis B and C)
- •10. Unresolved non-hematologic toxicities from prior therapies that are > Grade 1 per CTCAE v5.0
- •11. Presence of peripheral neuropathy = Grade 2 per CTCAE v5.0
- •12. Women who are already pregnant or lactating
- •13. Known intolerance or hypersensitivity to MMB or DAN, their metabolites, or formulation excipients.
- •14. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Note: DAN capsules contain lactose, further details are provided in protocol section 1.6.3.
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