A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CX-4945 Administered Orally to Patients With Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
This Phase 1 study of oral CX-4945 is designed to test the safety, tolerability, and highest safe dose level of this CK2 inhibitor in patients with relapsed or refractory multiple myeloma.
详细描述
Elevated CK2 activity has been associated with malignant transformation and aggressive tumor growth. Over expression of CK2 has been documented in multiple types of cancers, including multiple myeloma, and inhibition of CK2 represents a potential therapeutic strategy to target a specific molecular defect perpetuating many cancers. CX-4945 has demonstrated potent inhibition of CK2 enzymatic activity. This study will evaluate the safety, pharmacokinetics, and pharmacodynamic effects of CX-4945 when administered to patients with multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Males or females at least 18 years of age
- •Confirmed relapsed or refractory multiple myeloma after at least two prior lines of therapy.
- •Measureable disease.
- •Karnofsky Performance Status at least 60%
- •Adequate liver and renal function and hematology laboratory values
- •Female patients of child-bearing potential must have a negative pregnancy test.
- •Signed informed consent.
排除标准
- •Treatment with systemic cancer therapy within 21 days before screening.
- •Major surgery within 4 weeks or minor surgery within 2 weeks of the start of study drug.
- •Grade 3 sensory neuropathy or motor neuropathy with pain
- •Concurrent severe or uncontrolled medical disease.
- •Active systemic fungal, bacterial, and/or viral infection.
- •Difficulty with swallowing, or an active malabsorption syndrome.
- •Gastrointestinal diseases including Crohn's disease or hemorrhagic coloproctitis.
- •History of gastric or small bowel surgery.
- •Pregnant or nursing females.
研究组 & 干预措施
CX-4945
CX-4945 oral formulation
干预措施: CX-4945 (Drug)
结局指标
主要结局
Safety
时间窗: One year (assessed at Cycle 1).
Adverse events classified as Dose limiting toxicities. Determination of maximum tolerated dose.
次要结局
- Pharmacokinetic and pharmacodynamic assessments.(One year - assessed throughout all cycles of participation)
- Assess for efficacy response(One year (assessed after each cycle))
- Establish the recommended Phase 2 dose(One year)