NCT00570635已完成2 期
A Phase 2 Study of XL820 in Subjects With Advanced Gastrointestinal Stromal Tumors Resistant to or Intolerant of Imatinib and/or Sunitinib
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Exelixis
- 入组人数
- 16
- 主要终点
- Clinical benefit, defined as either confirmed complete response, confirmed partial response, or evidence of stable disease lasting ≥16 weeks, in subjects with advanced GIST resistant to/intolerant of imatinib and/or sunitinib
研究概览
简要总结
The purpose of this study is to evaluate the clinical benefit of the KIT inhibitor XL820 in subjects with advanced gastrointestinal stromal tumors (GIST) who are resistant to or intolerant of Imatinib and/or Sunitinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients with metastatic or locally advanced or unresectable GIST who have intolerance of or disease progression following prior treatment with imatinib and/or sunitinib
- •ECOG (Eastern Cooperative Oncology Group) performance status ≤2
- •Must have measurable disease per RECIST (Response Evaluation Criteria in Solid Tumors)
- •Recovery from toxicity from prior therapy to Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤1 or to subject's baseline status
- •Adequate organ and marrow function
- •Sexually active subjects (male and female) must agree to use accepted methods of contraception during the course of the study and for 3 months following discontinuation of study drugs.
- •Female subjects of childbearing potential must have a negative pregnancy test at enrollment.
排除标准
- •Therapy with imatinib or sunitinib within 14 days before the first dose of study drug
- •Chemotherapy, immunotherapy, targeted therapy, chemoembolization, or any investigational drug for the treatment of GIST after the last dose of imatinib or sunitinib
- •Anticoagulation with warfarin or coumarin-related compounds
- •Radiation to ≥25% of bone marrow within 28 days of study entry
- •Treatment with other investigational agents within 28 days of the first dose of XL820
- •Known central nervous systems metastases
- •Uncontrolled or intercurrent illness
- •Pregnancy or breast-feeding
- •Active bacterial or viral infection requiring systemic treatment
研究组 & 干预措施
A
Experimental
干预措施: XL820 (Drug)
B
Experimental
干预措施: XL820 (Drug)
结局指标
主要结局
Clinical benefit, defined as either confirmed complete response, confirmed partial response, or evidence of stable disease lasting ≥16 weeks, in subjects with advanced GIST resistant to/intolerant of imatinib and/or sunitinib
时间窗: Assessed at baseline, Week 4 and 8, and every 8 weeks thereafter
次要结局
- Safety and tolerability of XL820(Assessed at each visit)
- Progression-free survival, duration of response, and overall survival(Assessed until progression)
- Further characterize the pharmacokinetic and pharmacodynamic parameters of XL820 in subjects with advanced GIST(Assessed during periodic visits)
研究者
相似试验
已完成
1 期
Study of XL820 Given Orally Daily to Subjects With Solid TumorsCancerNCT00350831Exelixis30
终止
2 期
LGX818 for Patients With BRAFV600 Mutated TumorsSolid TumorHematologic MalignanciesNCT01981187Pfizer12
已完成
2 期
A Study of E7820 in People With Bone Marrow (Myeloid) CancersMyelodysplastic SyndromesAcute Myeloid LeukemiaChronic Myelomonocytic LeukemiaNCT05024994Memorial Sloan Kettering Cancer Center12
已完成
2 期
PTK787 in Patients With Advanced Metastatic Pancreatic AdenocarcinomaNeoplasmNCT00226005Pancreatic Cancer Research Team67
招募中
2 期
XL092 in Patients With Metastatic Castration-Resistant Prostate CancerMetastatic Castration-resistant Prostate CancerNCT06568562University of Utah32