NCT01095120Unknown2 期
A Phase II Study of Tesetaxel Administered at a Flat Dose Once Every 21 Days as Second-line Therapy to Subjects With Advanced Gastric Cancer
Genta Incorporated8 个研究点 分布在 3 个国家目标入组 27 人开始时间: 2010年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 27
- 试验地点
- 8
- 主要终点
- Response rate (Response Evaluation Criteria In Solid Tumors (RECIST))
研究概览
简要总结
Tesetaxel is an orally administered chemotherapy agent of the taxane class. This study is being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line therapy to patients with advanced gastric cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary inclusion criteria:
- •Confirmed diagnosis of adenocarcinoma of the stomach or esophagogastric junction
- •Measurable disease (revised RECIST; Version 1.1) based on computed tomography
- •Eastern Cooperative Oncology Group performance status 0 or 1
- •Treatment with only 1 prior regimen (as first-line therapy) and that regimen included a fluoropyrimidine and/or a platinum analogue
- •Documented disease progression within 4 months of the last dose of the 1 prior regimen
- •Adequate bone marrow, hepatic, and renal function, as defined in the protocol
- •At least 4 weeks and recovery from effects of prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy, with an approved or investigational agent
- •Ability to swallow an oral solid-dosage form of medication
排除标准
- •Nonmeasurable disease only (revised RECIST; Version 1.1)
- •History or presence of brain metastasis or leptomeningeal disease
- •Operable gastric cancer or operable cancer of the esophagogastric junction
- •Uncontrolled diarrhea, defined as more than 3 loose bowel movements above the patient's usual number of bowel movements on at least 2 days within the 14 days prior to enrollment
- •Uncontrolled nausea or vomiting within the 14 days prior to enrollment despite the administration of standard antiemetic therapy
- •Known malabsorptive disorder
- •Significant medical disease other than cancer, as defined in the protocol
- •Presence of neuropathy > Grade 1 (National Cancer Institute Common Toxicity Criteria [NCI CTC]; Version 4.0)
- •Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid
- •Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
结局指标
主要结局
Response rate (Response Evaluation Criteria In Solid Tumors (RECIST))
时间窗: 12 months from date of first dose of study medication
次要结局
- Adverse events(Through 30 days post last dose of study medication)
- Disease control rate (ie, the percentage of patients with a confirmed complete or partial response [of any duration] or stable disease at least 6 weeks in duration)(12 months from date of first dose of study medication)
- Durable response rate (ie, the proportion of patients with a confirmed complete or partial response at least 6 months in duration)(12 months from date of first dose of study medication)
- Duration of response(12 months from date of first dose of study medication)
研究者
研究点 (8)
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