NCT01348009Unknown1 期
A Phase I-II Study of Tesetaxel Plus Capecitabine and Cisplatin in Subjects With Advanced Gastric Cancer
Genta Incorporated1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2011年5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
- 63
- 试验地点
- 1
- 主要终点
- Progression-free survival rate (in Phase 2 portion of study)
研究概览
简要总结
Cisplatin, an intravenously administered platinum agent, in combination with an intravenously administered taxane and capecitabine has been shown to improve time to disease progression and overall survival in previously untreated patients with gastric cancer.
This study is being performed to evaluate an orally administered taxane (tesetaxel) in combination with cisplatin and capecitabine in previously untreated patients with 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 20 years of age
- •Histologically or cytologically confirmed gastric carcinoma, including gastric or gastroesophageal-junction adenocarcinoma.
- •Measurable disease (revised RECIST) based on computed tomography, or nonmeasurable disease
- •Previously untreated, unresectable advanced (M0) or unresectable metastatic (M1) disease except for prior adjuvant (or neo-adjuvant) chemotherapy.
- •ECOG performance status 0 or 1
- •At least 4 weeks and recovery from effects of prior major surgery
- •Adequate bone marrow, hepatic, and renal function
排除标准
- •Operable gastric or gastroesophageal-junction cancer
- •Known brain metastasis
- •Second cancer
- •Previous adjuvant or neo-adjuvant chemotherapy with capecitabine and cisplatin in combination. (Previous adjuvant or neo-adjuvant monotherapy with capecitabine or S-1 or therapy with S-1 and cisplatin in combination or 5-FU and cisplatin in combination is allowed.)
- •Uncontrolled diarrhea
- •Nausea or vomiting for at least 3 consecutive days within the 14 days prior to registration despite the administration of standard antiemetic therapy
- •Symptomatic peripheral neuropathy ≥ Grade 2
- •Malabsorption syndrome or other disease that significantly affects gastrointestinal function
- •Other uncontrolled systemic illness
研究组 & 干预措施
Tesetaxel-capecitabine-cisplatin
Experimental
干预措施: Tesetaxel-capecitabine-cisplatin (Drug)
结局指标
主要结局
Progression-free survival rate (in Phase 2 portion of study)
时间窗: 6 months from the date of first dose of study medication
次要结局
- Recommended dose of tesetaxel for Phase 2 (in Phase 1 portion of study)(Up to 21 days after first dose of study medication)
- Response rate, as defined in revised RECIST (in Phase 2 portion of study)(Up to 12 months following the date of first dose of study medication)
- Duration of response (in Phase 2 portion of study)(Up to 12 months following the date of first dose of study medication)
- Rate of responses at least 3 months in duration (in Phase 2 portion of study)(Up to 12 months following the date of first dose of study medication)
- Disease control rate, which is defined as the percentage of patients with a response of any duration or stable disease at least 6 weeks in duration (in Phase 2 portion of study)(Up to 12 months following the date of first dose of study medication)
- Durable response rate, which is defined as the percentage of patients with a response at least 6 months in duration (in Phase 2 portion of study)(Up to 12 months following the date of first dose of study medication)
- Progression-free survival (in Phase 2 portion of study)(Up to 12 months following the date of first dose of study medication)
- Overall survival (in Phase 2 portion of study)(Up to 12 months following the date of first dose of study medication)
- Percentage of patients with adverse events (in Phase 1 and Phase 2 portions)(Up to 30 days after the last dose of study medication)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
2 期
Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate CancerAggressive Variant Prostate CarcinomaCastration-Resistant Prostate CarcinomaMetastatic Prostate CarcinomaMetastatic Prostate Neuroendocrine CarcinomaMetastatic Prostate Small Cell CarcinomaStage IV Prostate Cancer AJCC v8NCT04592237M.D. Anderson Cancer Center120
Unknown
2 期
Tesetaxel for Previously Treated Patients With Bladder CancerCarcinoma, Transitional CellNCT01215877Genta Incorporated33
已完成
2 期
Phase II Study of Paclitaxel and Carboplatin plus Bevacizumab in StageIIIA-N2, IIIB, IV patients with Nonsquamous Non-Small-Cell Lung Cancerchemotherapy-na&iumlve StageIIIA-N2, IIIB, IV patients with nonsquamous non-small-cell lung cancerJPRN-UMIN000006809Akita University Graduate School of Medicine31
已完成
1 期
Phase I trial of Docetaxel+Cisplatin+Cetuximab(TPE) for recurrent/metastatic head and neck squamous cell carcinomahead and neck squamous cell carcinomaJPRN-UMIN000013170Osaka University Graduate School of Medicine Otorhinolaryngolory-Head and Neck Surgery12
Unknown
2 期
Tesetaxel as First-line Therapy for Metastatic Breast CancerBreast NeoplasmNCT01221870Genta Incorporated81