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临床试验/NCT04817007
NCT04817007进行中（未招募）1 期

A Phase 1b/2 Study of BMS-986158 Monotherapy and in Combination With Either Ruxolitinib or Fedratinib in Participants With DIPSS-Intermediate or High Risk Myelofibrosis

Bristol-Myers Squibb102 个研究点 分布在 12 个国家目标入组 216 人开始时间: 2021年3月22日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
216
试验地点
102
主要终点
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the safety, tolerability, and efficacy of BMS-986158 alone and in combination with either Ruxolitinib or Fedratinib in participants with Dynamic International Prognostic Scoring System (DIPSS)-intermediate or high risk blood cancer. Part 1 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and Part 2 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and BMS-986158 alone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of primary myelofibrosis (PMF), post-essential thrombocythemia (ET) or post-polycythemia vera (PV) myelofibrosis
  • •Treatment-related toxicities from prior therapy resolved to Grade 1 or pre-treatment baseline or determined to be irreversible prior to study treatment
  • •Must agree to follow specific methods of contraception, if applicable

排除标准

  • •Women who are pregnant or breastfeeding at screening
  • •Any significant acute or uncontrolled chronic medical illness
  • •Other protocol-defined inclusion/exclusion criteria apply

研究组 & 干预措施

Part 2A2 Add-On: BMS-986158 + Ruxolitinib

Experimental

干预措施: Ruxolitinib (Drug)

Part 2A1: BMS-986158 + Ruxolitinib

Experimental

干预措施: Ruxolitinib (Drug)

Part 1A: BMS-986158 + Ruxolitinib

Experimental

干预措施: BMS-986158 (Drug)

Part 2B1: BMS-986158 + Fedratinib

Experimental

干预措施: Fedratinib (Drug)

Part 2A3: BMS-986158 + Ruxolitinib

Experimental

干预措施: BMS-986158 (Drug)

Part 2A3: BMS-986158 + Ruxolitinib

Experimental

干预措施: Ruxolitinib (Drug)

Part 1A: BMS-986158 + Ruxolitinib

Experimental

干预措施: Ruxolitinib (Drug)

Part 1B: BMS-986158 + Fedratinib

Experimental

干预措施: BMS-986158 (Drug)

Part 1B: BMS-986158 + Fedratinib

Experimental

干预措施: Fedratinib (Drug)

Part 2A1: BMS-986158 + Ruxolitinib

Experimental

干预措施: BMS-986158 (Drug)

Part 2B1: BMS-986158 + Fedratinib

Experimental

干预措施: BMS-986158 (Drug)

Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable

Experimental

干预措施: BMS-986158 (Drug)

Part 2B2: BMS-986158 Mono and/or (BMS-986158 + Fedratinib), if applicable

Experimental

干预措施: Fedratinib (Drug)

Part 2A2 Add-On: BMS-986158 + Ruxolitinib

Experimental

干预措施: BMS-986158 (Drug)

结局指标

主要结局

Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria

时间窗: Up to 26 months

Incidence of AEs leading to discontinuation

时间窗: Up to 52 months

Incidence of death

时间窗: Up to 52 months

Incidence of adverse events (AEs)

时间窗: Up to 52 months

Incidence of serious adverse events (SAEs)

时间窗: Up to 52 months

次要结局

  • Spleen volume reduction (SVR) at end of Cycle 6 assessed by Blinded Independent Central Review (BICR)(Up to 175 days)
  • Response rate defined as proportion of participants with SVR ≥ 35% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR(Up to 175 days)
  • SVR at end of Cycle 3 and 6 assessed by BICR(Up to 175 days)
  • Response rate defined as proportion of participants with SVR ≥ 25% by MRI (preferred) or CT (if MRI is contraindicated and if CT is allowed by local guidelines) assessed by BICR(Up to 175 days)
  • Symptom response rate (SRR) based on total symptom score (TSS) measured by Myelofibrosis Symptom Assessment Form (MFSAF)(Up to 175 days)
  • Additional measures based on TSS measured by MFSAF(Up to 175 days)

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (102)

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