Protocol EC-FV-01: A Phase 1 Study of EC145 Administered in Weeks 1 and 3 of a 4-Week Cycle
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose During Cycle 1 Treatment
研究概览
简要总结
This is a Phase I clinical trial evaluating the safety and tolerability of escalating doses of vintafolide (EC145) in participants with relapsed or refractory advanced tumors. The primary objective of this study is to determine the safety and maximum tolerated dose of vintafolide given by intravenous bolus or infusion. The efficacy of the treatment will also be measured.
详细描述
This is a dose escalation study of vintafolide administered by intravenous (IV) bolus or infusion during weeks 1 and 3 of a 4-week cycle to participants with solid tumors refractory to current therapies. Vintafolide is a drug that is specifically designed to enter cells via a folate vitamin receptor. Experimental evidence shows that the target receptor is over-expressed in many human cancers. There are no previous human studies of vintafolide treatment; however, lab research (research in test tubes and/or animals) using vintafolide has shown activity against tumors in animals. This activity in animal models suggests that vintafolide may be useful as chemotherapy against human cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histological or cytological diagnosis of neoplasm
- •No effective standard therapeutic options
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •>=4 weeks post therapeutic radiation of chemotherapy >=6 weeks for nitrosoureas and mitomycin C) and recovery from associated toxicities
- •Negative serum pregnancy test for women of child-bearing potential and willingness to practice contraceptive methods
- •Adequate bone marrow reserve, renal, and hepatic function
排除标准
- •Concurrent hematological malignancies
- •Women who are pregnant or lactating
- •Evidence of symptomatic brain metastases
- •Receiving concomitant anticancer therapy (excluding supportive care)
- •Requires palliative radiotherapy at time of study entry
研究组 & 干预措施
Vintafolide 2.5 mg IV Bolus
Vintafolide 2.5 mg administered by IV bolus on Days 1, 3, 5, 15, 17, and 19 of 4-week treatment cycles
干预措施: Vintafolide IV Bolus (Drug)
Vintafolide 1.2 mg IV Bolus
Vintafolide 1.2 mg administered by IV bolus on Days 1, 3, 5, 15, 17, and 19 of 4-week treatment cycles
干预措施: Vintafolide IV Bolus (Drug)
Vintafolide 4.0 mg IV Bolus
Vintafolide 4.0 mg administered by IV bolus on Days 1, 3, 5, 15, 17, and 19 of 4-week treatment cycles
干预措施: Vintafolide IV Bolus (Drug)
Vintafolide 2.5 mg IV Infusion
Vintafolide 2.5 mg administered by a 1-hour IV infusion on Days 1, 3, 5, 15, 17, and 19 of 4-week treatment cycles
干预措施: Vintafolide IV Infusion (Drug)
Vintafolide 3.0 mg IV Infusion
Vintafolide 3.0 mg administered by a 1-hour IV infusion on Days 1, 3, 5, 15, 17, and 19 of 4-week treatment cycles
干预措施: Vintafolide IV Infusion (Drug)
结局指标
主要结局
Maximum Tolerated Dose During Cycle 1 Treatment
时间窗: Up to Day 26 in Treatment Cycle 1
Maximum Tolerated Dose (MTD) was defined as the highest dose that can safely be administered to a patient to produce acceptable, manageable and reversible toxicity. This level was further defined as the dose level at which no more than 1 of 6 participants had dose-limiting toxicity (DLT) and the level below the dose at which ≥2 of 6 participants had DLT.
次要结局
- Number of Participants with an Adverse Event Leading to Study Discontinuation During Cycle 1 Treatment(Up to Day 26 in Treatment Cycle 1)
- Number of Participants with Best Overall Tumor Response: Participants with Folate Receptor Positive Tumors at Baseline(Up to Week 24)
- Number of Participants with a Dose-Limiting Toxiciity During Cycle 1 Treatment(Up to Day 26 in Treatment Cycle 1)
- Area Under the Plasma Concentration-Time Curve (AUC) of Vintafolide on Day 3 of Treatment Cycle 1(Up to 90 minutes after IV bolus dosing and up to 60 minutes after the start of the 1-hour IV infusion on Day 3 of treatment cycle 1)
- Maximum Plasma Concentration (Cmax) of Vintafolide on Day 3 of Treatment Cycle 1(Up to 90 minutes after IV bolus dosing and up to 60 minutes after the start of the 1-hour IV infusion on Day 3 of treatment cycle 1)
- Area Under the Plasma Concentration-Time Curve (AUC) of Vintafolide on Day 1 of Treatment Cycle 1(Up to 90 minutes after IV bolus dosing and up to 60 minutes after the start of the 1-hour IV infusion on Day 1 of treatment cycle 1)
- Maximum Plasma Concentration (Cmax) of Vintafolide on Day 1 of Treatment Cycle 1(Up to 90 minutes after IV bolus dosing and up to 60 minutes after the start of the 1-hour IV infusion on Day 1 of treatment cycle 1)
- Number of Participants with Best Overall Tumor Response: All Treated Participants(Up to Week 24)