NCT04833582已完成1 期
A Phase 1/2 Dose Escalation and Dose Expansion Study of ZN-c3 in Combination With Gemcitabine in Adult and Pediatric Subjects With Relapsed or Refractory Osteosarcoma
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc17 个研究点 分布在 2 个国家目标入组 31 人开始时间: 2021年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 17
- 主要终点
- Incidence of dose-limiting toxicities (DLT) in DLT evaluable subjects and the incidence and severity of adverse events.
研究概览
简要总结
This is a phase 1/2 study of azenosertib (ZN-c3) in combination with gemcitabine in adult and pediatric subjects with relapsed or refractory osteosarcoma.
详细描述
This is a phase 1/2 dose escalation and dose expansion study, evaluating the clinical activity and safety, pharmacodynamics, and pharmacokinetics of azenosertib (ZN-c3) in combination with gemcitabine in relapsed or refractory osteosarcoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 12 years at the time of informed consent
- •Bodyweight ≥ 40 kg
- •Histologically documented relapsed or metastatic osteosarcoma.
- •Must have measurable disease according to RECIST Guideline version 1.1 criteria.
- •Adequate hematologic and organ function.
- •Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception per institutional standard prior to the first dose and for 6 months after study treatment discontinuation.
- •Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
排除标准
- •Unresolved toxicity of Grade >1 attributed to prior therapies (excluding: Grade ≤2 neuropathy, alopecia, or skin pigmentation)
- •Prior therapy with a WEE1 inhibitor
- •A serious illness or medical condition(s).
- •Pregnant or lactating females. Females of childbearing potential with a positive serum pregnancy test <14 days to Day
- •Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
- •12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of >470 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.
- •History or current evidence of congenital or family history of long QT syndrome or Torsades de Pointes (TdP).
- •Taking medications with a known risk of TdP.
- •Administration of strong and moderate CYP3A4 inhibitors/inducers and strong and moderate P-gp inhibitors.
研究组 & 干预措施
Azenosertib in combination with Gemcitabine
Experimental
Azenosertib (ZN-c3) in combination with Gemcitabine
干预措施: Azenosertib (Drug)
Azenosertib in combination with Gemcitabine
Experimental
Azenosertib (ZN-c3) in combination with Gemcitabine
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicities (DLT) in DLT evaluable subjects and the incidence and severity of adverse events.
时间窗: Through Cycle 1 (21 days) Phase 1
Event-free survival (EFS) at 18 weeks per RECIST (Response Evaluation Criteria in Solid Tumors) Guideline version 1.1.
时间窗: During phase 2, at 18 weeks
EFS at 18 weeks is defined as time from study enrollment until date of disease progression, or detection of disease at a previously uninvolved site, or date of death of the subjects at 18 weeks.
次要结局
- Event-free survival (EFS) per RECIST Guideline version 1.1.(At 12 months)
- Terminal half-life of the plasma PK concentration.(Through completion, approximately 42 months)
- The frequency and severity of adverse events (AEs) and laboratory abnormalities per the National Cancer Institute Common Terminology (NCI CTCAE) version 5.0.lities.(Through completion, approximately 42 months)
- Plasma PK time to maximum concentration (Tmax).(Through completion, approximately 42 months)
- Plasma pharmacokinetics (PK) maximum concentration (Cmax).(Through completion, approximately 42 months)
- Area under the plasma concentration versus timepoint curve (AUC last).(Through completion, approximately 42 months)
- Median overall survival (OS) and OS at 12 months per RECIST Guideline version 1.1.(At 12 months)
研究者
研究点 (17)
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