NCT02049281终止1 期
A Phase I Dose Escalation Study Evaluating MK-8109 (Vintafolide) in Japanese Subjects With Advanced Solid Tumor
Endocyte0 个研究点目标入组 3 人开始时间: 2014年2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
- 终止
- 发起方
- 入组人数
- 3
- 主要终点
- Number of Participants Experiencing Dose-limiting Toxicities
研究概览
简要总结
This study will evaluate thrice weekly dosing with vintafolide to find the maximum tolerable dose. The primary study hypothesis is that administration of vintafolide to participants with advanced solid tumors will have acceptable safety and tolerability.
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
- •Histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate organ function
排除标准
- •Chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 4 weeks prior to drug administration (6 weeks for nitrosoureas or mitomycin C) or not recovered from adverse events due to agents administered more than 4 weeks earlier
- •Primary central nervous system (CNS) tumor
- •Active CNS metastases and/or carcinomatous meningitis
- •Known hypersensitivity to the components of the study therapy or its analogs
- •Recent history of abdominal surgery or peritonitis
- •Bowel occlusion or sub occlusion
- •Prior abdominal or pelvis radiation therapy or radiation therapy to > 10% of the bone marrow at any time in the past or prior radiation therapy within the last three years to the breast / sternum, head, or neck
- •Requires anti-folate therapy
- •Symptomatic ascites or pleural effusion
- •Prior stem cell or bone marrow transplant
研究组 & 干预措施
Vintafolide
Experimental
Participants receive vintafolide intravenous (IV) bolus, starting dose 1.4 mg, on Days 1, 3, 5, 15, 17, and 19 of each 28-day cycle for up to 6 cycles.
干预措施: Vintafolide (Drug)
结局指标
主要结局
Number of Participants Experiencing Dose-limiting Toxicities
时间窗: Up to 28 days
次要结局
- Maximum Plasma Concentration (Cmax) of Vintafolide(Cycle 1, Day1 predose and at 2, 5, 10, 20, 30, 45, 60, 90 and 120 minutes post-dose)
- Area Under the Plasma Concentration-time Curve (AUC) for Vintafolide(Cycle 1, Day1 predose and at 2, 5, 10, 20, 30, 45, 60, 90 and 120 minutes post-dose)
- Plasma Concentration of desacetylvinblastine hydrazide (DAVLBH)(Cycle 1, Day1 predose and at 2, 5, 10, 20, 30, 45, 60, 90 and 120 minutes post-dose)
研究者
相似试验
已完成
1 期
Phase I Trial of BI 836845 for Various Solid CancerNeoplasmsNCT01403974Boehringer Ingelheim61
终止
1 期
A Study of MK-8109 (Vintafolide) Given Alone or With Chemotherapy in Participants With Advanced Cancers (MK-8109-001)Advanced CancerNCT01688791Endocyte37
招募中
1 期
IKS014 in Advanced Solid Tumors That Express HER2Gastroesophageal-junction CancerBreast CancerGastric CancerNCT05872295Iksuda Therapeutics Ltd.165
已完成
1 期
Phase I Clinical Study of Metatinib Tromethamine TabletAdvanced or Metastatic Solid TumorsNCT02004548Jiangsu Simcere Pharmaceutical Co., Ltd.18
已完成
1 期
Evaluation of KX2-391 in Elderly Subjects With Acute Myeloid Leukemia (AML)Acute Myelogenous LeukemiaNCT01397799Kinex Pharmaceuticals Inc.24