NCT01110603终止1 期
A Phase Ib Dose Escalation Study of MK-4827 in Combination With Carboplatin, Carboplatin/Paclitaxel and Carboplatin/Liposomal Doxorubicin in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Tesaro, Inc.
- 入组人数
- 12
- 主要终点
- Number of participants with dose limiting toxicities (DLTs)
研究概览
简要总结
This study will find the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of MK4827 when administered in combination with standard doses of carboplatin, or carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin in the treatment of advanced solid cancers in adults.
详细描述
The decision to discontinue new enrollment is not related to any concerns about the safety profile of the product.
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
- •Participant has a locally advanced or metastatic solid tumor for which carboplatin, carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin are the standard of care.
- •Participant has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
排除标准
- •Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks prior to entering the study.
- •Participant has had more than two prior lines of chemotherapy.
- •Participant has known central nervous system metastases or a primary central nervous system tumor.
- •Participant is pregnant or breastfeeding or expecting to conceive during the timeframe of the study.
- •Participant is known to be human immunodeficiency virus (HIV) positive.
- •Participant has a history of Hepatitis B or C.
- •Participant has a symptomatic pleural effusion.
- •Participant with a left ventricular ejection fraction (LVEF) below the institutional norm, or with prior exposure to doxorubicin is not eligible for the MK4827 + carboplatin/liposomal doxorubicin study arm.
研究组 & 干预措施
MK-4827 + carboplatin
Experimental
干预措施: MK-4827 (Drug)
MK-4827 + carboplatin
Experimental
干预措施: carboplatin (Drug)
MK-4827 + carboplatin/paclitaxel
Experimental
干预措施: MK-4827 (Drug)
MK-4827 + carboplatin/paclitaxel
Experimental
干预措施: carboplatin (Drug)
MK-4827 + carboplatin/paclitaxel
Experimental
干预措施: paclitaxel (Drug)
MK-4827 + carboplatin/liposomal doxorubicin
Experimental
干预措施: MK-4827 (Drug)
MK-4827 + carboplatin/liposomal doxorubicin
Experimental
干预措施: carboplatin (Drug)
MK-4827 + carboplatin/liposomal doxorubicin
Experimental
干预措施: liposomal doxorubicin (Drug)
结局指标
主要结局
Number of participants with dose limiting toxicities (DLTs)
时间窗: Each cycle (21 or 28 Days)
次要结局
- Number of participants with clinical and laboratory adverse events (AEs)(Baseline to 30 days post last dose)
研究者
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