NCT01430416已完成1 期
A Phase 1 Study of AEB071, an Oral Protein Kinase C Inhibitor, in Patients With Metastatic Uveal Melanoma
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
- 153
- 试验地点
- 3
- 主要终点
- Number of participants reporting serious adverse events and adverse events - Dose Expansion
研究概览
简要总结
This study has two parts, dose escalation and dose expansion. For dose escalation, the primary objective is to estimate the maximum tolerated dose (MTD) of AEB071 in patients with uveal melanoma. For dose expansion, the primary objective is to characterize the safety and tolerability of the MTD of AEB071 in patients with uveal melanoma.
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
- •Uveal melanoma with biopsy proven metastatic disease
- •Males and females ≥ 18 years of age
- •Consent to biopsy of tumor
- •Measurable disease according to RECIST version 1.1
- •WHO performance status of ≤ 1
排除标准
- •Patients with abnormal laboratory values as defined by the protocol
- •Patients who are receiving treatment with strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued prior to study entry
- •Patients with impaired cardiac function or clinically significant cardiac diseases as defined by the protocol
- •Patients with another malignancy that was treated within the last three years with the exceptions of localized basal cell carcinoma and cervical carcinoma
- •Patients with impairment of gastrointestinal function or disease
- •Patients with severe systemic infections
- •Patients who are known to be HIV positive and/or have active hepatitis B or C infection
- •Time since last therapy for treatment of underlying malignancy:
- •Cytotoxic chemotherapy: ≤ duration of the most recent cycle of the previous regimen (a minimum of 2 weeks for all)
- •Nitrosurea: ≤ 6 weeks
- •Biologic therapy: ≤ 4 weeks
- •≤ 5 x PK half-life of a small molecule therapeutic not otherwise defined above
- •Patients having undergone major surgery less than 4 weeks prior to enrollment or have not fully recovered from prior surgery
- •Women of child-bearing potential unless they are using highly effective methods of contraception during the dosing and for at least 36 hours after last dose. Highly effective contraception as defined in the protocol.
- •Patients with primary central nervous system tumors or brain metastases.
- •Pregnant or nursing (lactating) women.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
AEB071
Experimental
干预措施: AEB071 (Drug)
结局指标
主要结局
Number of participants reporting serious adverse events and adverse events - Dose Expansion
时间窗: Baseline, every 28 days
Frequency of dose limiting toxicity during cycle 1 (28 days) - Dose Escalation
时间窗: cycle 1 (28 days)
次要结局
- Gα genotype in tumor specimens(Baseline, 28 days)
- Overall response rate (Complete Response (CR) + Partial Response(PR)) to AEB071 using RECIST version 1.1(Baseline, 12 months)
- Progression free survival and time to progression using RECIST version 1.1(Baseline, 12 months)
- Number of patients reporting serious adverse events and adverse events(Baseline, 12 months)
- AEB071/AEE800 pharmacokinetic parameters including Cmax, tmax, AUCτ, Ctrough, CL/F, and RA(First 7 months of treatment period)
研究者
研究点 (3)
Loading locations...
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