PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Phase I: To find the maximum tolerated dose (MTD) or the highest tolerated dose (HTD) as the study dose of PG2; Phase II: To use the study dose and assess the WBC level of PG2
研究概览
简要总结
The objectives of this Phase I/II study are:
- To find out the maximum tolerated dose (MTD) of PG2 in patients with advanced malignancy receiving chemotherapy and to define a "Study Dose" for Phase II.
- To evaluate the hematopoietic and immunological responses after administering of PG2. Primarily to study the biological response of PG2, defined as WBC count in this study, and secondarily to study the immunological factors, IL-2, IL-6, TGF-beta, and G-CSF.
详细描述
This study is the first step for PG2 clinical development in Taiwan in order to further establish its safety and efficacy profile and to build the basis for larger trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have malignancy with metastatic or recurrent diseases.
- •Patient must have a minimum of thirteen days period elapsed from any previous chemotherapy or radiotherapy and all treatment-related toxicities subsided.
- •Patient must have at least 2 courses of chemotherapy treatment left, and a minimum of 13 days between the administration of the last dose of the chemotherapy with PG2 and the start of the next course of chemotherapy.
- •Performance status is 0-2 by ECOG scale.
- •Patient's compliance and geographic proximity that allow adequate follow up.
- •Adequate bone marrow function before the chemotherapy
- •Adequate liver and renal function before the chemotherapy
- •Written informed consent from patients
- •Woman with childbearing potential should use contraception method through the whole PG2 treatment course.
- •After the previous course of chemotherapy, the nadir of WBC dropped between 1000 to 3000/ mm3 (for phase II only).
排除标准
- •PG2 skin test is positive.
- •Active infection
- •Breast feeding
- •Prior radiotherapy more than 30% of the bone marrow involved.
- •Pregnant woman
- •Bone marrow transplantation or brain disease
研究组 & 干预措施
125 mg/day Treatment Arm
125 mg/day PG2 treatment continuously for 7 days
干预措施: PG2 (Drug)
250 mg/day Treatment Arm
250 mg/day PG2 treatment continuously for 7 days
干预措施: PG2 (Drug)
500 mg/day Treatment Arm
500 mg/day PG2 treatment continuously for 7 days
干预措施: PG2 (Drug)
结局指标
主要结局
Phase I: To find the maximum tolerated dose (MTD) or the highest tolerated dose (HTD) as the study dose of PG2; Phase II: To use the study dose and assess the WBC level of PG2
时间窗: within 14 days of each chemotherapy cycle
For phase I study, the primary endpoint is to determine a safe dosage of PG2 by the dose escalation design. For phase II study, the primary endpoint is to compare the WBC level between PG2 plus chemotherapy and chemotherapy alone.
次要结局
- Phase II: To use the study dose to assess the hematopoietic and immunological cytokine levels(within 14 days of each chemotherapy cycle)