NCT01240655已完成1 期
A Phase Ib Study of LCL161 in Combination With Weekly Paclitaxel in Adult 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
- 已完成
- 入组人数
- 76
- 试验地点
- 4
- 主要终点
- Maximum tolerated dose (MTD)/RP2D of LCL161 when administered in combination with once weekly paclitaxel
研究概览
简要总结
This is a dose escalation study that will assess the safety and efficacy of LCL161 in combination with weekly paclitaxel in adult patients with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with breast cancer must have a histologically or cytologically confirmed diagnosis of disease that has metastasized or is resistant to therapy.
- •Patients with ovarian cancer must have histological evidence of recurrent epithelial ovarian, fallopian tube or peritoneal cancer.
- •Patients must have recovered or stabilized from all toxicities related to their previous treatment except for alopecia Male or female patients 18 years or older ECOG performance status 0-1 Life expectancy greater than 12 weeks Measurable disease as determined by RECIST v1.0 Patients must give written informed consent and comply with the protocol
排除标准
- •For patients with breast cancer:
- •Concurrent Her2-directed or anti-estrogen therapy
- •For patients with ovarian cancer:
- •Primary refractory disease, defined as progression during initial treatment with a platinum- and taxane-containing regimen.
- •Prior treatment with weekly paclitaxel. More than two chemotherapy regimens given in the relapse setting. Evidence of a documented bowel obstruction within six months of study entry Patients with unresolved peripheral neuropathy, nausea, vomiting, or diarrhea ≥ CTCAE Grade 2 Any concurrent severe and/or uncontrolled medical conditions that could increase the patient's risk for toxicity while in the study or that could confound discrimination between disease- and study treatment-related toxicities.
- •Patients with impairment of GI function or GI disease that may significantly alter the absorption of LCL161 Patients who have undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of procedure.
- •Pregnant or breast feeding (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive β-HCG laboratory test (> 5 mIU/mL).
- •Known diagnosis of human immunodeficiency virus (HIV) infection or chronic active hepatitis B or C (HIV and hepatitis testing are not mandatory).
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
LCL161 + Paclitaxel
Experimental
干预措施: Paclitaxel (Drug)
LCL161 + Paclitaxel
Experimental
干预措施: LCL161 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)/RP2D of LCL161 when administered in combination with once weekly paclitaxel
时间窗: 24 months
次要结局
- Target inhibition, cell death, and cytokines in surrogate and tumor tissues(24 months)
- Safety and tolerability of the combination, including acute and chronic toxicities(24 months)
- Pharmacokinetics of both LCL161 and paclitaxel when administered in combination (AUC0-∞, Cmax, tmax and other parameters as appropriate)(24 months)
- Preliminary anti-tumor activity associated with this combination treatment(24 months)
研究者
研究点 (4)
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