A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 10
- 主要终点
- To demonstrate bioequivalent area under the time concentration curve (AUC) for both drug products
研究概览
简要总结
The purpose of this study is to demonstrate that a new formulation of an Bendamustine (BDM) Hydrochloride (HCl) is bioequivalent (BE) (similar) to the commercially available product in patients with cancer.
详细描述
This is an open-label, randomized, crossover, Phase I study intended to demonstrate the BE, and safety and tolerability profile of 2 formulations of BDM HCl administered to cancer patients: Eagle-BDM and Teva-BDM Histologically confirmed diagnosis of any malignant disease (solid tumors and hematologic malignancies are eligible) for which no curative or standard therapy is appropriate.
At the end of the study, patients may be enrolled into an open-label extension (OLE) study (Study EGL-BDM-C-1301-OLE), at the discretion of the investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Histologically confirmed diagnosis of any malignant disease for which no curative or standard therapy is appropriate.
- •Bone Marrow Function and Blood Chemistry results within protocol limits
排除标准
- •Presence of brain metastases
研究组 & 干预措施
Eagle-BDM; Teva-BDM; Teva-BDM
Eagle-BDM: IV Teva-BDM: IV
干预措施: Test Product (Bendamustine) (Drug)
Teva-BDM; Eagle-BDM;Teva-BDM
Eagle-BDM: IV Teva-BDM: IV
干预措施: Test Product (Bendamustine) (Drug)
Teva-BDM, Teva-BDM, Eagle-BDM
Eagle-BDM: IV Teva-BDM: IV
干预措施: Test Product (Bendamustine) (Drug)
结局指标
主要结局
To demonstrate bioequivalent area under the time concentration curve (AUC) for both drug products
时间窗: Participants will be in the study for up to 65 days
Each patient will receive 3, single doses of study medication in a 56 day treatment period (2 cycles of 28 days each). Medication will be administered on Cycle 1, Day 1; Cycle 1, Day 2; and Cycle 2, Day 1. Each patient will receive 1 dose of Eagle-BDM and 2 doses of Teva-BDM in 3 randomly assigned, varying treatment sequences(Eagle-BDM, Teva-BDM, Teva-BDM; Teva-BDM, Eagle-BDM, Teva-BDM; or Teva-BDM, Teva-BDM, Eagle-BDM). Pharmacokinetic assessments will be performed.
次要结局
未报告次要终点