NCT00796484终止1 期
A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL888 in Subjects With 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
- Exelixis
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Plasma pharmacokinetics of oral administration of XL888 when administered on an intermittent schedule
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of XL888 in subjects with solid tumors. XL888 is a potent and selective inhibitor of HSP90, a key component of a molecular chaperone complex that promotes the conformational maturation and stabilization of diverse client proteins. Many HSP90 client proteins play critical roles in signaling pathways implicated in tumor cell growth, proliferation, and survival.
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
- •Subject has a histologically-confirmed tumor that is metastatic or unresectable and is no longer responding to therapies known to prolong survival or to other standard therapies, or has disease for which no effective therapy exists.
- •For subjects enrolling in the maximum tolerated dose expansion cohorts:
- •Subject has documented evidence of Her2-overexpressing tumor; OR
- •Subject has NSCLC that has progressed after a prior response to erlotinib or gefitinib; OR
- •Subject has histologically-confirmed, metastatic melanoma.
- •For subjects in the expansion cohorts A and C: tumor tissue must be accessible for biopsy and subjects must be willing to undergo tumor biopsy.
- •The subject is ≥ 18 years old.
- •The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤
- •The subject's weight is ≥ 40 kg.
- •The subject has adequate organ and marrow function.
- •The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document.
- •Sexually active subjects (male and female) must use accepted methods of contraception during the course of the study and for 3 months after the last dose of XL
- •Female subjects of childbearing potential must have a negative pregnancy test at screening.
排除标准
- •The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic therapy (cytokines, antibodies) within 3 weeks (or nitrosoureas or mitomycin C within 6 weeks) before the first dose of XL
- •The subject has received prior treatment with a small molecule kinase inhibitor (including an investigational kinase inhibitor) or hormonal therapy within 14 days before the first dose of XL
- •The subject has received any other type of investigational agent within 28 days before the first dose of study treatment.
- •The subject has a previously-identified allergy or hypersensitivity to components of the study treatment formulation.
- •The subject has not recovered from clinically-meaningful toxicity due to prior therapy.
- •The subject has been previously treated with an HSP90 inhibitor
- •The subject has untreated or uncontrolled brain metastases or evidence of leptomeningeal involvement of disease.
- •The subject is currently receiving anticoagulation with therapeutic dose of warfarin.
- •The subject has uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; diabetes mellitus; hypertension; symptomatic congestive heart failure, unstable angina pectoris, stroke or myocardial infarction within 3 months.
- •The subject has a baseline corrected QT interval (QTc) > 460 ms.
- •The subject is pregnant or breastfeeding.
- •The subject is known to be positive for the human immunodeficiency virus (HIV).
- •The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
研究组 & 干预措施
1
Experimental
干预措施: XL888 (Drug)
结局指标
主要结局
Plasma pharmacokinetics of oral administration of XL888 when administered on an intermittent schedule
时间窗: Assessed at several visits during weeks 1 through 4 of the first cycle and approximately once every four weeks each cycle thereafter
Safety, tolerability, and maximum tolerated dose of oral administration of XL888 when administered on an intermittent schedule to adults with solid tumors
时间窗: Assessed at several visits during weeks 1 through 4 of the first cycle and approximately every other week each cycle thereafter
次要结局
- Pharmacodynamic effects of XL888 on both tumor tissue and non-tumor tissue(Assessed at specific visits during the first cycle; mandatory blood samples collected once every four weeks every cycle thereafter with optional tissue samples)
- Exploratory: To evaluate preliminary antitumor activity of XL888(Assessed every eight weeks)
- Estimate renal elimination of XL888(Assessed during the first cycle after three weeks of dosing)
研究者
研究点 (2)
Loading locations...
相似试验
暂停
1 期
Study of XL418 in Adults With Solid TumorsSolid TumorsCancerNCT00460278Exelixis63
已完成
1 期
Study of the Safety and Pharmacokinetics of XL147 (SAR245408) in Adults With Solid Tumors or LymphomaCancerLymphomaNCT00486135Sanofi118
终止
1 期
Safety Study of XL844 in Subjects With Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaChronic Lymphocytic LeukemiaNCT00234481Exelixis
已完成
1 期
Study of XL820 in Adults With Solid TumorsCancerNCT00129571Exelixis
进行中（未招募）
1 期
XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV MelanomaMelanomaSkin CancerNCT02721459H. Lee Moffitt Cancer Center and Research Institute26