NCT02431260终止1 期
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054329 in Subjects With Advanced Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 69
- 试验地点
- 12
- 主要终点
- Number of Participants With a Treatment-emergent Adverse Event (TEAE)
研究概览
简要总结
This was a study of INCB054329 given to patients with advanced malignancies that were conducted in three treatment groups. Each treatment group had a dose escalation (Part 1) and a dose expansion (Part 3), two of the treatment groups also had an intra-patient dose titration (Part 2).
研究设计
- 研究类型
- Interventional
- 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
- •Confirmed diagnosis of advanced malignancy:
- •Treatment Group A (TGA): Part 1 and Part 2: Any advanced solid tumor or lymphoma; Part 3: Histologically confirmed disease in specific solid tumors and lymphomas
- •Treatment Group B (TGB): Acute Leukemia (Part 3 - acute myeloid leukemia [AML] only), myelodysplastic syndrome (MDS), myelodysplastic /myeloproliferative neoplasms (MDS/MPN) and myelofibrosis (MF)
- •Treatment Group C (TGC): Multiple myeloma
- •Progressed following at least 1 line of prior therapy and there is no further approved therapy available that has been demonstrated to prolong survival (including subjects who are intolerant to the approved therapy)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 in Parts 1 and 2 dose escalation and titration, and 0, 1, 2 in Part 3 dose expansion
排除标准
- •Inadequate hematopoietic, liver, endocrine or renal function
- •Receipt of anticancer medications or investigational drugs within the following interval before the first administration of study drug:
- •< 6 weeks for mitomycin-C or nitrosoureas
- •< 5 half-lives or 14 days, whichever is longer, for any investigational agent (for any indication)
- •< 28 days for any antibodies or biological therapies
- •< 5 half-lives for all other anticancer medications, or sponsor approval
- •Prior radiotherapy within 2 weeks prior to first dose of study drug
- •Untreated brain or central nervous system (CNS) metastases
- •Type 1 diabetes or uncontrolled Type 2 diabetes
- •Any sign of clinically significant bleeding
研究组 & 干预措施
INCB054329 Monotherapy
Experimental
干预措施: INCB054329 Monotherapy (Drug)
结局指标
主要结局
Number of Participants With a Treatment-emergent Adverse Event (TEAE)
时间窗: up to 30 days
TEAE is defined as an adverse event reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
次要结局
- Maximum Plasma Concentration (Cmax) Analysis of INCB054329(Summary of steady-state PK parameters by dosing regimen at Day 15)
- Time to Maximum Plasma Concentration (Tmax) Analysis of INCB054329(Summary of steady-state PK parameters by dosing regimen at Day 15)
- Minimum Observed Plasma Concentration Over the Dose Interval (Cmin) Analysis of INCB054329(Summary of steady-state PK parameters by dosing regimen at Day 15)
- AUC0-t Analysis of INCB054329(Summary of steady-state PK parameters by dosing regimen at Day 15)
- Cl/F Analysis of INCB054329(Summary of steady-state PK parameters by dosing regimen at Day 15)
- Objective Response Rate (ORR)(Baseline through end of study, up to 6 months)
- Progression Free Survival (PFS)(Baseline through end of study, up to 6 months)
- Pharmacodynamics (PD) Analysis - Total c-Myc % Inhibition Versus INCB054329(Day 15 in all cohorts)
- Duration of Response (DOR)(Baseline through end of study, up to 6 months)
- Overall Survival (OS)(Baseline through end of study, up to 6 months for participants in Part 2)
研究者
研究点 (12)
Loading locations...
相似试验
终止
1 期
An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced MalignanciesSolid TumorsAdvanced MalignanciesMetastatic CancerNCT02265510Incyte Corporation83
终止
1 期
An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced MalignanciesSolid Tumors and Hematologic MalignancyNCT02712905Incyte Corporation116
已完成
1 期
A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Itacitinib in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101)B-Cell MalignanciesNCT02018861Incyte Corporation88
已完成
1 期
A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors PatientsAdvanced/Metastatic Solid TumorsNCT04501276Adagene Inc72
终止
1 期
Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced MalignanciesSolid TumorsNCT02711137Incyte Corporation137