KCT0005293招募中未知
An open-label, multi-center phase IB/II study of abemaciclib with paclitaxel for CDK4/6 pathway activated tumors
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •? Histologically or cytologically confirmed locally advanced or metastatic solid tumors, for which standard therapy proven to provide clinical benefit no longer
- •? CDK4/6 activated tumors on next-generation sequencing or FISH (fluorescence in situ hybridization) analyses
- •- CCND1, 2, or 3 high-level amplification, CCND1 mutation, or a CCND1 splice variant expected to lead to nuclear retention of cyclin D1 protein
- •- CDK4 or CDK6 high-level amplification
- •? ECOG performance status of 0 to 1
- •? = 19 years of age
- •? Subjects with measurable or evaluable disease
- •? Subjects who meet the following criteria:
- •- Absolute neutrophil count (ANC) = 1500 /µL (*ANC = Neutrophil segs + Neutrophil bands)
- •- Platelet count = 75,000/ µL
- •- Serum creatinine < 1.5 x upper limit of normal (ULN)
- •- AST (SGOT) and ALT (SGPT) < 3 x upper limit of normal (ULN) (If there is Liver Metastasis < 5 x upper limit of normal (ULN))
- •-Total bilirubin < 1.5 x upper limit of normal (ULN)
- •? Provision of written informed consent prior to any study procedure
排除标准
- •? Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy.
- •? Any previous chemotherapy or immunotherapy within 2 weeks or at least 3-5 half-lives for previous chemo/immunotherapy whichever is longer.
- •? Any major operation or irradiation within 2 weeks of baseline disease assessment
- •? Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
- •? Previously abemaciclib-exposed patients
- •? Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms
- •? Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma, thyroid cancer or cervical cancer in situ.
- •? Subjects with an uncontrolled major cardiovascular disease (including AMI within 12 months, unstable angina within 6 months, over NYHA class III congestive heart failure, congenital long QT syndrome, 2° or more AV Block and uncontrolled hypertension)
- •? Active infection including hepatitis B, hepatitis C
- •? Pregnant or lactating female
研究者
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