NCT01371617已完成2 期
A Phase 2 Study of IPI-926 in Patients With Myelofibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- To determine the overall response rate of IPI-926, defined as clinical improvement (CI); partial remission (PR); and complete remission (CR), according to the International working group (IWG) criteria in patients with Myelofibrosis
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of IPI-926 in patients with myelofibrosis (MF) (primary myelofibrosis [PMF], post-polycythemia vera myelofibrosis [post-PV MF], or post-essential thrombocythemia myelofibrosis [post-ET MF]).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age at the time of signing the ICF.
- •Voluntarily sign an ICF.
- •Pathologically confirmed PMF or post ET/PV MF as per the WHO diagnostic criteria (note that it must include at least Grade 1 marrow fibrosis, see Appendix 3) with intermediate-1, intermediate -2, or high risk disease according to the IWG prognostic scoring system (see Appendix 4). If patients have low risk disease, then they must have symptomatic splenomegaly that is ≥ 10 cm below left costal margin by physical exam.
- •ECOG performance of 0-
- •Life expectancy of at least 3 months.
- •Recovery to Grade 1 or baseline of any toxicities due to prior systemic treatments, excluding alopecia.
- •If a woman, be of non-child bearing potential or, for women of child-bearing potential (WCBP) (defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally post-menopausal for at least 24 consecutive months for women ≤55 years; for women >55 years 12 consecutive months), must have a negative serum or urine pregnancy test result within 2 weeks of first dose of study drug.
- •All WCBP and all sexually active male patients must agree to use adequate methods of birth control throughout the study. Adequate methods of contraception include use of oral contraceptives with an additional barrier method, double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera, partner vasectomy, and total abstinence.
- •Ability to adhere to the study visit schedule and all protocol requirements.
排除标准
- •Prior treatment with any inhibitor of the hedgehog pathway (e.g. GDC-0449).
- •Received any treatment for myelofibrosis within 2 weeks of study entry.
- •Other invasive malignancies diagnosed within the last 3 years, except non-melanoma skin cancer and localized cured prostate and cervical cancer.
- •Inadequate hepatic function defined by:
- •Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN).
- •Direct bilirubin >1.5 x ULN.
- •Cirrhotic liver disease, ongoing alcohol abuse, or known chronic active or acute hepatitis.
- •Inadequate renal function defined by serum creatinine >2 x ULN.
- •History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.
- •Presence of active infection or systemic use of antibiotics within 72 hours of treatment.
- •Significant co-morbid condition or disease, which in the judgment of the Investigator, would place the patient at undue risk or interfere with the study.
- •Known human immunodeficiency virus (HIV) positivity.
- •Known hypersensitivity to IPI-926, or any of the excipients in IPI-926 capsules.
- •Pregnant or lactating women.
研究组 & 干预措施
IPI-926
Experimental
Single Arm, Phase 2 trial evaluating the safety and efficacy of IPI-926 in patients with myelofibrosis
干预措施: IPI-926 (Drug)
结局指标
主要结局
To determine the overall response rate of IPI-926, defined as clinical improvement (CI); partial remission (PR); and complete remission (CR), according to the International working group (IWG) criteria in patients with Myelofibrosis
时间窗: At least 2 months
次要结局
未报告次要终点
研究者
研究点 (3)
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