NL-OMON44750已完成不适用
A phase Ib, multi-center, open-label, dose-escalation study of PIM447 in combination with ruxolitinib (INC424) and LEE011 administered orally in patients with myelofibrosis (CPIM447X2104C) - CPIM447X2104C
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 4
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
- 18 至 99（—）
入选标准
- •* ECOG performance status 0, 1, 2.
- •* JAK2V617F-positive primary or secondary myelofibrosis.
- •* < 35% reduction in spleen volume by MRI/CT or < 50% reduction in spleen size by physical exam, with or without corresponding symptomatic improvement, after at least 6 months of treatment with single agent ruxolitinib at an optimal dose level in line with label recommendations.
- •* Expansion parts only: Ruxolitinib-naive patients and patients who have been previously treated with single agent ruxolitinib and are relapsed and/or refractory.
- •* Splenomegaly measuring at least 5 cm by MRI at baseline.
- •* Adequate bone marrow function (Platelets * 100 x 10 9/L - Absolute Neutrophil Count * 1.5 x 109/L - Hb * 9 g/dL <= 5,58 mmol/L).
排除标准
- •* Systemic antineoplastic therapy or any experimental therapy within 14 days or 5 half-lives before the first dose of study treatment
- •* Major surgery within 2 weeks before the first dose of study drug.
- •* Splenic irradiation within 2 weeks prior to Screening or splenectomy.
- •* AML, MDS, or peripheral blasts > 5 %.
- •* Prior autologous or allogeneic stem cell transplant.
- •* Treatment with a prohibited medication that cannot be discontinued at least one week prior to the start of treatment (Appendix 1), including agents that are:
- •- substrates of CYP3A4/5, CYP2B6 or CYP2D6 that have a narrow therapeutic window
- •- strong inhibitors of CYP3A4/5 or CYP2D6
- •- potent inducers of CYP3A4/5 or CYP2D6
- •* Medication with a known risk of prolonging the QT interval or inducing Torsades de Pointes (protocol appendix 2).
- •* History of (or predisposition to) clinically significant bleeding, history of platelet dysfunction and/or bleeding diathesis, and/or regular use of drugs that interfere with coagulation or inhibit PLT function (Appendix 3). NOTE: low doses of aspirin * 125 mg/day are allowed.
- •* Total bilirubin > 1.5 x upper limit of normal (ULN), AST (SGOT) or ALT (SGPT) > 3 x ULN, except with liver involvement AST or ALT > 5 x ULN.
- •* Creatinine > 1.5 x ULN or calculated creatinine clearance < 60 ml/min according to Cockcroft-Gault equation.
- •* Electrolyte abnormalities CTCAE grade * 2
- •* Patients with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study treatments
- •* Unresolved nausea, vomiting, or diarrhea of CTCAE grade * 2.
- •* Active infection requiring systemic therapy or other severe infection within 2 weeks before the first dose of either study drug.
- •* Impaired cardiac function or clinically significant cardiac diseases (refer to exclusion criterion #19)
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