EUCTR2016-001657-41-IT进行中（未招募）1 期
A Phase 1b Dose Escalation Study Evaluating the Safety andPharmacokinetics of Venetoclax in Combination with Azacitidine inSubjects with Treatment-Naïve Higher-Risk Myelodysplastic Syndromes(MDS) - n/a
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject must voluntarily sign and date an informed consent, approved
- •by an Independent Ethics Committee (IEC)/Institutional Review Board
- •(IRB), prior to the initiation of any screening or study specific
- •procedures.
- •2. Subject must be = 18 years of age.
- •3. Subject must have documented diagnosis of previously untreated de
- •novo MDS with:
- •¿ International Prognostic Scoring System (IPSS) risk categories Int-2
- •or High (IPSS overall score = 1.5) and
- •¿ Presence of = 5% and < 20% bone marrow blasts per bone marrow
- •biopsy/aspirate at screening
- •4. Subject must have an Eastern Cooperative Oncology Group (ECOG)
- •performance score of = 2.
- •5. Subject is not a candidate to undergo intensive chemotherapy or
- •allogeneic hematopoietic stem cell transplantation (HSCT).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Subject has received prior therapy for MDS.
- •2. Subject has received prior therapy with a BH3 mimetic.
- •3. Subject has received allogeneic HSCT or solid organ transplantation .
- •4. Subject has received a live attenuated vaccine within 4 weeks prior to
- •the first dose of study drug.
研究者
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