NCT01315431Unknown1 期
A Phase I Study of Tesetaxel Administered in Combination With Capecitabine to Subjects With Solid Tumors
Genta Incorporated1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This study is being performed to confirm the safety of tesetaxel 27 mg/m2 (Day 1) in combination with capecitabine 2000/mg/m2/day (in 2 equally divided doses on Days 1 through 14) in a 21-day cycle.
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
- •At least 18 years of age
- •Confirmed diagnosis of a solid tumor malignancy, excluding lymphoma
- •Chemotherapy-naïve or previously treated with not more than 1 non-taxane-containing chemotherapy (Enrollment of patients with a history of prior taxane therapy in the adjuvant setting is allowed provided at least 6 months have passed since the conclusion of that therapy.)
- •ECOG performance status of 0 or 1
- •Adequate bone marrow, hepatic, and renal function
- •At least 3 weeks and recovery from effects of prior surgery and anticancer therapy, with resolution of any toxicity to not more than Grade 1
排除标准
- •Brain metastasis or leptomeningeal disease
- •Second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which patient has been disease-free for 5 or more years)
- •Known history of human immunodeficiency virus infection or hepatitis B or hepatitis C infection
- •Recurrent diarrhea, defined as more than 3 episodes than is usual in any 24-hour period within the 30 days prior to enrollment in this study
- •Significant medical disease other than cancer
- •Neuropathy at least Grade 2
- •Difficulty swallowing
- •Malabsorptive disorder
- •Need for other anticancer treatment while receiving study medication
- •Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity. A washout period of at least 2 weeks is required prior to the first dose of study medication.
- •Pregnancy or lactation
- •History of hypersensitivity to tesetaxel, capecitabine, 5-fluorouracil, or any of their components
研究组 & 干预措施
Tesetaxel-capecitabine
Experimental
干预措施: Tesetaxel plus capecitabine (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Through 30 days following the last dose of study medication
Percentage of subjects with adverse events
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
Tesetaxel Every 3 Weeks vs Weekly vs Capecitabine as 1st-line Therapy for Locally Advanced or Metastatic Breast CancerLocally Advanced Non-resectable Breast CancerMetastatic Breast CancerNCT01609127Genta Incorporated213
已完成
1 期
CESAR Study in Prostate Cancer With Temsirolimus Added to Standard Docetaxel Therapy (CEPTAS)Prostatic NeoplasmsNCT01206036Central European Society for Anticancer Drug Research19
Unknown
2 期
Docetaxel, Carboplatin, and Capecitabine as Treatment for Patients With Locally Advanced or Inflammatory Breast Cancer Before SurgeryBreast CancerNCT00251329Cancer Research Network48
Unknown
2 期
Tesetaxel for Previously Treated Patients With Bladder CancerCarcinoma, Transitional CellNCT01215877Genta Incorporated33
进行中（未招募）
1 期
Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted TreatmentNCT05627245National Cancer Institute (NCI)48