NL-OMON52828已完成2 期
A randomized, open-label, phase I/II open platform study evaluating safety and efficacy of novel ruxolitinib combinations in myelofibrosis patients - CINC424H12201 (ADORE)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 7
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 64（—）
入选标准
- •* Subjects have diagnosis of primary myelofibrosis (PMF) according to the 2016
- •World Health Organization (WHO) criteria, or diagnosis of post-essential
- •thrombocythemia (ET) (PET-MF) or post-polycythemia vera (PV) myelofibrosis
- •(PPV-MF) according to the International Working Group for Myelofibrosis
- •Research and Treatment (IWG-MRT) 2007 criteria
- •* Palpable spleen of at least 5 cm or enlarged spleen volume of at least 450
- •cm3 per MRI or CT scan at baseline (a MRI/CT scan up to 8 weeks prior to first
- •dose of study treatment can be accepted).
- •* Have been treated with ruxolitinib for at least 12 weeks prior to first dose
- •of study treatment
- •* Are stable (no dose adjustments) on the prescribed ruxolitinib dose (between
- •5 and 25 mg twice a day (BID)) for * 4 weeks prior to first dose of study
- •* Hemoglobin < 11 g/dL
- •* Part 1: Platelet counts * 75 000/*L
- •* Part 2 and Part 3: Platelet counts * 50 000/*L
排除标准
- •* Not able to understand and to comply with study instructions and
- •requirements.
- •* Received any investigational agent for the treatment of MF (except
- •ruxolitinib) within 30 days of first dose of study treatment or within 5
- •half-lives of the study treatment, whichever is greater
- •* Peripheral blood blasts count of >10%.
- •* Received a monoclonal antibody (Ab) or immunoglobulin-based agent within 1
- •year of screening, or has documented severe hypersensitivity
- •reactions/immunogenicity (IG) to a prior biologic
- •* Splenic irradiation within 6 months prior to the first dose of study drug
- •* Received blood platelet transfusion within 28 days prior to first dose of
- •study treatment. PRBC transfusions are permitted
- •* Subjects with known TP53 mutation or deletion of TP53
研究者
相似试验
进行中（未招募）
1 期
A safety, pharmacokinetics and preliminary efficacy study of novel ruxolitinib combination treatments in patients with myelofibrosisPMF or PPV- MF, or PET- MFMedDRA version: 20.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-000373-23-ESovartis Farmacéutica, S.A130
进行中（未招募）
1 期
A safety, pharmacokinetics and preliminary efficacy study of novel ruxolitinib combination treatments in patients with myelofibrosisEUCTR2019-000373-23-DEovartis Pharma AG240
进行中（未招募）
1 期
A safety, pharmacokinetics and preliminary efficacy study of novel ruxolitinib combination treatments in patients with myelofibrosisEUCTR2019-000373-23-ROovartis Pharma AG240
进行中（未招募）
1 期
A safety, pharmacokinetics and preliminary efficacy study of novel ruxolitinib combination treatments in patients with myelofibrosisEUCTR2019-000373-23-ITovartis Pharma AG130
进行中（未招募）
1 期
A safety, pharmacokinetics and preliminary efficacy study of novel ruxolitinib combination treatments in patients with myelofibrosisEUCTR2019-000373-23-DKovartis Pharma AG240