JPRN-jRCT2031210490招募中1 期
A Phase 1/2, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-3654 in Patients with Intermediate or High-Risk Primary or Secondary Myelofibrosis
Koike Haruhiko0 个研究点目标入组 60 人开始时间: 2021年12月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 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
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Confirmed pathological diagnosis of primary myelofibrosis (PMF) or post-PV-MF/post-ET- MF as per WHO diagnostic criteria and intermediate or high-risk primary or secondary MF based on the Dynamic International Prognostic Scoring System (DIPSS)
- •2)Previously treated with a JAK inhibitor and failed on a JAK inhibitor or are ineligible to be treated with Ruxolitinib or Fedratinib at the discretion of the investigator
- •3)Grade >= 2 bone marrow fibrosis, as confirmed by bone marrow biopsy within 12 weeks prior to Screening
- •4)Fulfill the following laboratory parameters:
- •a.Platelet count >= 25 X 10^9 /L, without the assistance of growth factors or platelet transfusions
- •b.Absolute Neutrophil Count (ANC) >= 1 x 10^9/L without the assistance of granulocyte growth factors
- •c.Peripheral blood blast count < 10%
- •5)Eastern Cooperative Oncology Group (ECOG) performance status <= 2
- •6)Life expectancy >= 3 months
- •7)Adequate renal function, as determined by clinical laboratory tests (serum creatinine <= 1.5 x upper limit of normal (ULN), and calculated creatinine clearance >= 30 mL/min) (Cockcroft-Gault)
- •8)Adequate hepatic function (ALT/AST <= 3 x ULN, total bilirubin <= 1.5 x ULN; or ALT/AST <= 5 x ULN, direct bilirubin <= 2 x ULN if due to myelofibrosis), and coagulation ([PT and PTT] <= 1.5 x ULN)
- •9)Agree to provide bone marrow biopsies during the study: at baseline or within 12 weeks prior to enrollment, and every 6 months during treatment.
- •10)Splenomegaly during the screening period as demonstrated by splenic length >= 5 cm below the costal margin by palpation or spleen volume of >= 450 cm3 by Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) scan
- •11)Show at least 2 symptoms measurable (score >= 1) using the MFSAF, v4.0.
排除标准
- •1)Received previous systemic antineoplastic therapy (including unconjugated therapeutic antibodies, toxin immunoconjugates, ESA, and alpha-interferon) or any experimental therapy within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment.
- •2)Major surgery within 2 weeks before the first dose of either study drug.
- •3)Splenic irradiation within 6 months prior to Screening or prior splenectomy.
- •4)AML, MDS, or peripheral blasts >= 10%.
- •5)Prior autologous or allogeneic stem cell transplant at any time.
- •6)Eligible for allogeneic bone marrow or stem cell transplantation within 3 months following enrollment.
- •7)Experiencing electrolyte abnormalities of NCI CTCAE Grade >= 2 unless they can be corrected during screening and are deemed not clinically significant by the Investigator.
- •8)History of congestive heart failure, myocardial infarction within the past 6 months prior to Cycle 1/Day 1; left ventricular ejection fraction < 45% by echocardiogram or MUGA, unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG) within 14 days prior to Cycle 1/Day 1.
- •9)Corrected QT interval (using Fridericia's correction formula) of > 450 msec in men and > 470 msec in women.
- •10)Central nervous system (CNS) cancer or metastases, meningeal carcinomatosis, malignant seizures, or a disease that either causes or threatens neurologic compromise (eg, unstable vertebral metastases).
- •11)Other invasive malignancies within the last 3 years, except non-melanoma skin cancer, and localized cured prostate and cervical cancer
- •12)Experienced portal hypertension or any of its complications.
- •13)Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic antimicrobial within 14 days.
- •14)Known bleeding diathesis or signs of uncontrolled active bleeding (hematuria, GI bleeding) other than self-limited causes of benign etiology that have been adequately investigated at the discretion of the Investigator.
- •15)Requiring anticoagulation with aspirin > 81mg daily, unfractionated heparin, low molecular weight heparin (LMWH), direct anti-thrombin inhibitors, or vitamin K antagonists (eg, warfarin).
- •16)Severe chronic obstructive pulmonary disease with hypoxemia (defined as resting O2 saturation of < 90% breathing room air).
- •17)Medical condition or have undergone significant surgery to the gastrointestinal tract that could impair absorption or that could result in short bowel syndrome with diarrhea due to malabsorption.
- •18)Used hydroxyurea or anagrelide within 24 hours prior to the first dose.
- •19)Systemic steroid therapy (>10 mg daily prednisone or equivalent) within 7 days prior to the first dose of study treatment (note: topical, inhaled, nasal, and ophthalmic steroids are not prohibited).
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