A Phase Ib Clinical Study of BBI608 for Adult Patients With Advanced, Refractory Hematologic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 8
- 主要终点
- Determination of the safety and tolerability of BBI608 administered as monotherapy and in combination with dexamethasone, bortezomib, imatinib or ibrutinib by assessing dose-limiting toxicities (DLTs)
研究概览
简要总结
This is a multicenter, open label, Phase 1 dose-escalation study of BBI608 administered to patients with relapsed, refractory hematologic malignancies, including multiple myeloma, lymphoma, and others.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Signed written informed consent must be obtained and documented according to the International Conference on Harmonisation (ICH) and be in accordance with local regulatory requirements
- •A histologically confirmed hematologic malignancy that is advanced, relapsed, or refractory to standard, currently available anti-cancer treatment options
- •≥ 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at dose escalation phase and of ≤ 2 at dose expansion phase
- •Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after their last dose
- •Females of childbearing potential must have a negative serum pregnancy test
- •Aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN) and alanine transaminase (ALT) ≤ 2.5 × upper limit of normal (ULN). Patients whose disease involves the liver and who have laboratory values of AST ≤ 3.5 ULN, AST ≤ 3.5 ULN, and albumin ≥ 35g/L may be enrolled if agreed upon by the Principal Investigator and Medical Monitor for the Sponsor
- •Total bilirubin < 1.5 x ULN, except for cases in which elevation of total bilirubin is due to elevated levels of unconjugated bilirubin consistent with a diagnosis of Gilbert's Syndrome
- •Life expectancy ≥ 3 months
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Patients with multiple myeloma treated with BBI608
干预措施: BBI608 (Drug)
Arm 2
Patients with lymphoma treated with BBI608
干预措施: BBI608 (Drug)
Arm 6
Patients with multiple myeloma treated with BBI608 and bortezomib
干预措施: BBI608 (Drug)
Arm 3
Patients with acute myeloid leukemia or myelo-dysplastic syndrome treated with BBI608
干预措施: BBI608 (Drug)
Arm 4
Patients with chronic myeloid leukemia treated with BBI608
干预措施: BBI608 (Drug)
Arm 5
Patients with multiple myeloma treated with BBI608 and dexamethasone
干预措施: BBI608 (Drug)
Arm 5
Patients with multiple myeloma treated with BBI608 and dexamethasone
干预措施: Dexamethasone (Drug)
Arm 6
Patients with multiple myeloma treated with BBI608 and bortezomib
干预措施: Bortezomib (Drug)
Arm 7
Patients with chronic myeloid leukemia treated with BBI608 and imatinib
干预措施: BBI608 (Drug)
Arm 7
Patients with chronic myeloid leukemia treated with BBI608 and imatinib
干预措施: Imatinib (Drug)
Arm 8
Patients with chronic lymphocytic leukemia treated with BBI608
干预措施: BBI608 (Drug)
Arm 9
Patients with chronic lymphocytic leukemia treated with BBI608 and ibrutinib
干预措施: BBI608 (Drug)
Arm 9
Patients with chronic lymphocytic leukemia treated with BBI608 and ibrutinib
干预措施: Ibrutinib (Drug)
结局指标
主要结局
Determination of the safety and tolerability of BBI608 administered as monotherapy and in combination with dexamethasone, bortezomib, imatinib or ibrutinib by assessing dose-limiting toxicities (DLTs)
时间窗: 4 weeks
次要结局
- Pharmacokinetic profile of BBI608 when administered in monotherapy and in combination with dexamethasone, bortezomib, imatinib or ibrutinib as assessed by maximum plasma concentration and area under the curve(-5min, 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, 11, 12 hours on day 1, cycles 1 and 2)
- Pharmacodynamic activity of BBI608 when administered in monotherapy and in combination with dexamethasone, bortezomib, imatinib or ibrutinib as assessed by biomarker analysis(20 weeks)
- Assessment of the preliminary anti-tumor activity by performing tumor assessments(20 weeks)