Phase 1b/2 Clinical Study of the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles of CFI-400945 as a Single Agent or in Combination With Azacitidine in Patients With AML, MDS or CMML
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 9
- 主要终点
- Incidence of treatment emergent AEs
研究概览
简要总结
The purpose of this study is to test the safety of an investigational drug called CFI-400945 alone and in combination with azacitidine.
详细描述
This study will be evaluating the safety and tolerability of CFI-400945 in subjects with Acute Myeloid Leukemia, Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia. The study is designed to build on encouraging data from another study and to obtain further safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) data of CFI-400945.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients must be >18 years of age
- •For Parts 1A and 1B, the following malignancy types will be included:
- •Relapsed or refractory AML.
- •MDS, after prior hypomethylating agents.
- •CMML, with progressive disease/lack of response after hypomethylating agents
- •For Parts 1A and 1B, Patients may have relapsed or refractory disease.
- •For Parts 2A and 2B, the following malignancy types will be included:
- •Relapsed or Refractory AML.
- •MDS patients should be limited to high risk disease
- •MDS or CMML should be previously untreated and patients with AML may have relapsed or refractory disease;
- •Have clinically acceptable laboratory screening results (i.e., clinical chemistry, hematology, and urinalysis) within certain limits per protocol.
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
排除标准
- •Patients who have received investigational therapy, radiotherapy, immunotherapy, monoclonal antibodies, or chemotherapy within 14 days or 5 half-lives (whichever is shorter)
- •Allogeneic or autologous transplant for AML with infusion of stem cells within 90 days before Cycle 1 Day 1, or on active immunosuppressive therapy for graft-versus-host disease (GVHD) or GVHD prophylaxis within 2 weeks of Cycle 1 Day
- •Any Grade ≥ 2 persistent non-hematological toxicity related to allogeneic transplant, such as those requiring systemic immunosuppressive therapy.
研究组 & 干预措施
1A: Monotherapy escalation and expansion
Dose escalation and expansion arm with CFI-400945
干预措施: CFI-400945 (Drug)
2A: Combination escalation and expansion
Dose escalation and expansion arm with CFI-400945 and azacitidine
干预措施: CFI-400945 (Drug)
2A: Combination escalation and expansion
Dose escalation and expansion arm with CFI-400945 and azacitidine
干预措施: Azacitidine (Drug)
结局指标
主要结局
Incidence of treatment emergent AEs
时间窗: 36 months
The number of subjects who experience an adverse event that was possibly related to study drug
Treatment emergent changes in physical examinations, ECOG performance status, electrocardiograms (ECGs), echocardiograms and cardiac troponins
时间窗: 36 months
The number of subjects who experience changes in physical examinations, performance status, ECG, troponins that were possibly related to study drug.
Treatment emergent changes in vital signs
时间窗: 36 months
The number of subjects who experience changes in blood pressure, heart rate, respiratory rate, body temperature that was possibly related to study drug.
Treatment emergent changes in clinical laboratory tests
时间窗: 36 months
The number of subjects who experience a change in laboratory parameters that was possibly related to study drug.
次要结局
- Overall response rate (ORR, defined as Complete remission + Marrow CR + Partial remission + Hematologic Improvement (CR + mCR+ PR + HI)(36 months)
- The pharmacokinetics of CFI-400945 will be assessed through AUC.(36 months)
- Composite Complete Remission Rate, CRc (complete remission + complete remission with incomplete blood count recovery + complete remission with incomplete platelet count recovery [CR + CRi + CRp])(36 months)
- To assess the pharmacokinetic profile of CFI-400945 through T1/2.(36 months)
- To assess the pharmacokinetic profile of CFI-400945 through Cmax.(36 months)