NCT02034227终止1 期
An Open-Label, Phase 1/Phase 2 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of the DNA Minor Groove Binding Agent SG2000 in the Treatment of Advanced Chronic Lymphocytic Leukemia and Acute Myeloid Leukemia
Spirogen2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2012年4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
- 6
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose (MTD) of SG2000.
研究概览
简要总结
The purpose of this study is to determine if the experimental drug, SG2000 is safe and tolerable in the treatment of participants with advanced chronic lymphocytic leukemia and acute myeloid leukemia whose standard treatment did not work, whose cancer came back or who are not candidates for other types of standard therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female greater than or equal to 18 years of age
- •have one of the following disease states: Acute Myeloid Leukemia (AML) (age <60 years) with relapsed/refractory disease; •Chronic Lymphocytic Leukemia (CLL) with relapsed disease following a fludarabine-based regimen or relapsed disease following an alkylator-based regimen
- •are recovered from the acute adverse effects of prior therapies (excluding alopecia and Grade ≤2 neuropathy).
- •have blast counts that can be controlled by the use of hydroxycarbamide (500 to 3000 mg daily).
- •have adequate hepatic function and renal function
- •have an estimated life expectancy of >3 months
- •female subject must have a negative serum pregnancy result within 7 days before the start of the study; Both men and women must agree to use a medically acceptable form of contraception throughout the treatment period and for 3 months after discontinuation of treatment
排除标准
- •are eligible for any standard therapy known to be life prolonging or life saving
- •have diagnosis of AML French-American-British (FAB) classification (FAB) M3 (acute promyelocytic leukemia (APL))
- •are receiving concurrent chemotherapy, radiotherapy, immunotherapy, biological or hormonal treatment for cancer.
- •have undergone anticancer therapy including chemotherapy (except for hydroxycarbamide at a maximum daily dose of 3000 mg), endocrine therapy, immunotherapy, or the use of other investigational agents within 4 weeks before study entry.
- •prior radiation therapy with volume of bone marrow treated over 25%.
- •use of immunosuppressive therapy, including systemic steroids within 7 days before the first dose of SG
- •hyperleukocytosis (blast counts >30 000/mm3).
- •history of allogeneic stem cell or solid organ transplantation.
- •positive serology for human immunodeficiency virus (HIV), hepatitis B or hepatitis C or have HIV-AIDS, or active hepatitis B or C.
- •history of other invasive malignancy within 3 years except for cervical carcinoma in situ, nonmelanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has been surgically cured.
- •have any coexisting medical condition that will substantially increase the risk associated with the subject's participation in the study.
- •have psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of necessary studies.
- •have persistent Grade 2 or greater toxicities from any cause (except alopecia or peripheral neuropathy).
- •are pregnant or breast-feeding.
研究组 & 干预措施
SG2000 - 15 µg/m2/day
Experimental
Cohort 1 - will commence at 15 µg/m2/day intravenous doses of SG2000 until Maximum Tolerated Dose is determined.
干预措施: SG2000 (Drug)
SG2000 - 30 µg/m2/day
Experimental
Cohort 2 - will commence at 30 µg/m2/day intravenous doses of SG2000 until Maximum Tolerated Dose is determined.
干预措施: SG2000 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of SG2000.
时间窗: From 1st dose of SG2000 given on days 1, 2 and 3, every 21-days, for six 21-day cycles (approximately 16 weeks).
The Maximum Tolerated Dose (MTD) will be determined based on the assessment of the dose-limiting toxicity (DLT) during the DLT period; period is defined as the time from the first dose intravenous doses of SG2000 for 3 consecutive days every 21 days for 1 to 6 cycles until unacceptable toxicity, consent withdrawal, or another reason to discontinue therapy intervenes.
次要结局
- time to reach Cmax(day-1 of each 21-day cycle (cycles 1 and 3) at the following time points: predose, 15 minutes (middle of infusion), 30 minutes (end of infusion), and at 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 24 hours after the end of infusion.)
- hematology and serum chemistry(baseline, days 1,2,3,4,8,15, and 21 for six 21-day cycles.)
- bone marrow aspirate(day-1 (predose), and day- 8 of each 21-day cycle (cycles 1 and 3) and day -1 of cycles 2 and 4)
- pulse oximetry(baseline, day-1 to day-21 for six 21-day cycles.)
- electrocardiogram(days 1, 8, 15, 21, and at Day 22 after the last cycle or early termination.)
- safety profile(day -1 to day- 21 for six 21-day cycles .)
- terminal half life (T1/2),(day-1 of each 21-day cycle (cycles 1 and 3) at the following time points: predose, 15 minutes (middle of infusion), 30 minutes (end of infusion), and at 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 24 hours after the end of infusion.)
- Physical examination(baseline, day-1 to day 21 for six 21-day cycles.)
- Maximum plasma concentration (Cmax)(day-1 of each 21-day cycle (cycles 1 and 3) at the following time points: predose, 15 minutes (middle of infusion), 30 minutes (end of infusion), and at 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 24 hours after the end of infusion.)
- Vital signs(baseline, day-1 to day-21 for six 21-day cycles.)
- area under the concentration-time curve (AUC)(day-1 of each 21-day cycle (cycles 1 and 3) at the following time points: predose, 15 minutes (middle of infusion), 30 minutes(end of infusion), and at 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 24 hours after the end of infusion.)
研究者
研究点 (2)
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