NL-OMON48854已完成2 期
An Open-Label Phase 2 Study of Itacitinib (INCB039110) in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Subjects With Myelofibrosis - INCB_39110-209
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
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
- •Cohort A only
- •Receiving ruxolitinib dose of less than 20 mg daily with no dose increase or
- •no dose modification in the last 8 weeks before screening visit.
- •Cohort B only
- •Must have had initial reduction in spleen on ruxolitinib treatment (response
- •is defined by any spleen length or volume reduction, by palpation or MRI/CT
- •assessment, from baseline while on previous ruxolitinib treatment per IWG-MRT
- •ELN 2013 guidelines):
- •- Followed by documented evidence of progression in spleen length or volume OR
- •- Discontinued ruxolitinib for hematologic toxicities, after the initial
- •reduction in spleen length or volume.
- •All subjects
- •Men and women, aged 18 years or older.
- •Confirmed diagnosis of PMF, PPV-MF, or PET-MF according to revised WHO 2016
- •Must have palpable spleen of >= 5 cm below the left subcostal margin on
- •physical examination at the screening visit. (If spleen is not palpable due to
- •body habitus, spleen enlargement must be documented by other means [eg,
- •ultrasound or MRI] and study sponsor medical monitor be contacted for
- •acceptance).
- •ECOG performance status of 0, 1, or 2.
- •Screening bone marrow biopsy specimen available or willingness to undergo a
- •bone marrow biopsy at screening/baseline; willingness to undergo bone marrow
- •biopsy at Week 24.
- •Life expectancy of at least 24 weeks.
- •Willingness to avoid pregnancy or fathering children based on the following
- •- Woman of nonchildbearing potential (ie, surgically sterile with a
- •hysterectomy and/or bilateral oophorectomy OR >= 12 months of amenorrhea and at
- •least 50 years of age).
- •- Woman of childbearing potential who has a negative serum pregnancy test at
- •screening and negative urinary test before the first dose on Day 1 and who
- •agrees to take appropriate precautions to avoid pregnancy (with at least 99%
- •certainty) from screening through safety follow-up. Permitted methods that are
- •at least 99% effective in preventing pregnancy should be communicated to the
- •subject and their understanding confirmed.
- •- Man who agrees to take appropriate precautions to avoid fathering children
- •(with at least 99% certainty) from screening through safety follow-up.
- •Permitted methods that are at least 99% effective in preventing pregnancy
- •should be communicated to the subject and their understanding confirmed.
排除标准
- •All subjects
- •Lack of recovery from all toxicities from previous therapy (except
- •ruxolitinib) to Grade 1 or better.
- •Previous treatment with itacitinib or JAK1 inhibitors (JAK1/JAK2 inhibitor
- •ruxolitinib is permitted).
- •Inability to swallow food or any condition of the upper gastrointestinal
- •tract that precludes administration of oral medications.
- •Unwillingness to be transfused with blood components.
- •Recent history of inadequate bone marrow reserve as demonstrated by the
- •- Platelet count < 50 × 109/L in the 4 weeks before screening or platelet
- •transfusion within 8 weeks before screening.
- •- Absolute neutrophil count levels < 0.5 × 109/L in the 4 weeks before
- •- Peripheral blood blast count of > 10% at the screening or baseline hematology
- •assessments.
- •Inadequate liver function at screening and baseline visits as demonstrated by
- •the following:
- •- Direct bilirubin >= 2.0 × the upper limit of laboratory normal (ULN). (NOTE:
- •direct bilirubin may be assumed to be within limits if total bilirubin is <= 2.0
- •- Alanine aminotransferase or aspartate aminotransferase > 2.5 × ULN.
- •Inadequate renal function at screening and baseline visits as demonstrated by
- •creatinine clearance < 40 mL/min measured or calculated by Cockroft-Gault
- •equation, or glomerular filtration rate < 40 mL/min/1.73 m2 as calculated using
- •the Modification of Diet in Renal Disease formula.
- •Active bacterial, fungal, parasitic, or viral infection that requires
- •therapy. Subjects with acute infections requiring treatment should delay
- •screening/enrollment until the course of therapy has been completed and the
- •event is considered resolved. Prophylactic antibiotics will be permitted.
- •Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or
- •risk of reactivation: HBV DNA and HCV RNA must be undetectable. Subjects cannot
- •be positive for hepatitis B surface antigen or anti-hepatitis B core
- •antibodies. Subjects who have positive anti-HBs as the only evidence of prior
- •exposure may participate in the study provided that there is both 1) no known
- •history of HBV infection and 2) verified receipt of hepatitis B vaccine.
- •Known human immunodeficiency virus infection.
- •Clinically significant or uncontrolled cardiac disease, including unstable
- •angina; acute myocardial infarction within 6 months of Day 1 of study drug
- •administration; New York Heart Association Class III or IV congestive heart
- •failure; and arrhythmia requiring therapy unless approved by medical
- •monitor/sponsor.
- •Active invasive malignancy over the previous 2 years except treated basal or
- •squamous carcinomas of the skin, completely resected intraepithelial carcinoma
- •of the cervix, and completely resected papillary thyroid and follicular thyroid
- •cancers. Subjects with malignancies with indolent behavior such as prostate
- •cancer treated with radiation or surgery may be enrolled as long as they have a
- •reasonable expectation to have been cured with the treatment modality received.
- •Splenic irradiation within 6 months before receiving the first dose of
- •itacitinib.
- •Use of any prohibited concomitant medications.
- •Active alcohol or drug addiction that would interfere with their ability to
- •comply with the study requirements.
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研究者
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