NCT01128998已完成1 期
An Open-Label Phase I Dose-Escalation Study of Sorafenib Plus S-1 in Advanced Solid Tumors
National Health Research Institutes, Taiwan1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Determination of MTD/RD
研究概览
简要总结
Primary Objective:
- To define the recommended dose for phase II study of S-1 combined with sorafenib
- To evaluate the dose-limiting toxicities of the combination therapy
Secondary Objectives:
- To characterize the pharmacokinetics (PK) of sorafenib and S-1 in the combination therapy
- To investigate the impact of genetic polymorphisms of metabolic genes on the PK of sorafenib and S-1, respectively, as well as on the toxicity profile of the combination.
- To determine the changes of biomarkers between pre- and post-treatments.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven metastatic or locally advanced malignant solid tumors, which are refractory to current standard systemic treatment.
- •Have measurable lesion.
- •20-75 y/o.
- •ECOG performance score no more than
- •Life expectancy > 12 weeks.
- •Adequate hematopoietic, hepatic and renal functions.
- •Hemoglobin > 9.0 g/dl
- •Absolute neutrophil count > 1,500/mm3
- •Platelet count 100,000/ mm3
- •Total bilirubin < 1.5 times the upper limit of normal (ULN)
- •ALT and AST < 2.5 x ULN
- •Serum creatinine < 1.0 x ULN
- •Recovery from prior therapy that given > 4 weeks before enrolment.
- •No pregnancy and breast-feeding.
- •Signed informed consent.
排除标准
- •Severe cardiovascular disorders.
- •Pulmonary fibrosis or interstitial pneumonia.
- •HIV infection.
- •Active infection.
- •Major anti-cancer treatment within 4 weeks of study entry.
- •Exposure to the current investigational agent before.
- •Known or suspected allergy to the current investigational agent.
- •Unable to swallow oral medications.
- •Substance abuse, medical, psychological or social conditions interfering with the patient's participation or evaluation of the study results.
- •Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
- •Symptoms of bowel obstruction, malnutrition, splenomegaly.
- •Receiving active anti-coagulant therapy.
- •Patients with concurrent CYP 2A6 and/or CYP 3A4 or 3A5 inducers or inhibitors; a minimal of 2 weeks wash-out period required.
研究组 & 干预措施
S-1 and Sorafenib
Experimental
干预措施: Sorafenib (Drug)
S-1 and Sorafenib
Experimental
干预措施: S-1 (Drug)
结局指标
主要结局
Determination of MTD/RD
时间窗: First two cycles
次要结局
- Dose-limiting Toxicity(First two cycles)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Phase I-II to Evaluate Efficacy/Safety of Sorafenib+Gemcitabine+Radiotherapy in Locally Advanced Pancreatic CarcinomaPancreatic CancerNCT00789763Grupo Espanol Multidisciplinario del Cancer Digestivo12
招募中
1 期
A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.CLLChronic Lymphocytic LeukemiaMantle Cell LymphomaMCLNCT06697184BeOne Medicines258
已完成
1 期
Safety and Tolerability Study of SOR-C13 in Subjects With Advanced Cancers Commonly Known to Express the TRPV6 ChannelCancerNCT01578564Soricimed Biopharma Inc23
已完成
1 期
Safety Study of ALRN-6924 in Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic SyndromeMyelodysplastic SyndromesAcute Myeloid LeukemiaNCT02909972Aileron Therapeutics, Inc.55
已完成
1 期
Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic CancerPancreatic Cancer MetastaticPancreatic Cancer Stage IVStage IV Pancreatic CancerNCT03412799Panbela Therapeutics, Inc.50